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Body Fluids

Cerebrospinal Fluid (CSF)

Buoro S et al. (2018) Int J Lab Hematol; 40(1): 26:
Two-site evaluation of the diagnostic performance of the Sysmex XN Body Fluid (BF) module for cell count and differential in Cerebrospinal Fluid.
What we see as the essence:
The XN-BF mode provides rapid and accurate counts from of cerebrospinal fluid samples in clinically relevant ranges. It was found to provide a good alternative to conventional microscopic analysis.
Fleming C et al. (2015) Clin Chem Lab Med.; 54(1):e19:
Liposomal interference on Sysmex XN-series body fluid mode.
What we see as the essence:
Liposomal particles from DepoCyt chemotherapy treatment may be misclassified as polymorphonuclear cells by the XN-BF mode (software version 18). The authors worked together with Sysmex to develop an alert, available from software version 20.
Li A et al. (2014) Scand J Clin Lab Invest.; 74(8):673:
Automated white blood cell counts in cerebrospinal fluid using the body fluid mode on the platform Sysmex XE-5000.
What we see as the essence:
“In the present study, we found that the open body fluid mode of the Sysmex XE-5000 was a favourable method for determination of WBC counts and for differentiation between MNCs and PMNs, compared to manual counting."
Zur B et al. (2012) Cen Eur Neurosurg 73: 93–8:
Evaluation of 2 Hematology Analyzers in Body Fluid Mode versus Flow Cytometry Immunophenotyping of Mainly Neurosurgical Cerebrospinal Fluid Samples.
What we see as the essence:
"Determination of CSF cells with the XE-5000 is presently the best automated method for counting leukocytes of blood-stained CSF."
Zimmermann M et al. (2011) Int J Lab Hematol. 33: 629–37:
Automated vs. manual cerebrospinal fluid cell counts: a work and cost analysis comparing the Sysmex XE-5000 and the Fuchs-Rosenthal manual counting chamber.
What we see as the essence:
Using the XE-5000 for automated counting in CSF is trustworthy especially for severely pathological cell counts, but also below. The study demonstrates specific and significant savings in terms of time and money (about 6 times).
Sandhaus LM et al. (2010) Am J Clin Pathol 134: 734–738:
Automated cerebrospinal fluid cell counts using the Sysmex XE-5000: is it time for new reference ranges?
What we see as the essence:
The correlation between XE-5000 and Fuchs-Rosenthal chamber over the entire range of data was very good. Studies are needed to determine method-specific reference intervals for white blood cells in CSF.
Boer K et al. (2009) Clin Biochem 42: 684–691:
Evaluation of the XE-5000 for the automated analysis of blood cells in cerebrospinal fluid.
What we see as the essence:
Most patients were classified correctly using the XE-5000 which is thus suitable for automated quantification of white blood cells in CSF in a defined diagnostic setting. This could significantly improve automation of CSF diagnostics.

General Body Fluids

Favresse J et al (2018) Int J Lab Hematol; 40(2): e28:
Characterization of Candida spp. interference on the Sysmex XN-1000 body fluid mode.
What we see as the essence:
The presence of yeast interferes with WBC and TC counts, and in a less extend with HF count when measuring body fluids on the XN-1000. “Therefore, the assessment of the typical “blue surfboard pattern” is also useful to identify the presence of yeast as it is important for laboratory specialists to report their presence” The absence of the flag “WBC abn Scattergram” does not proof that there are no interferences.
Cho YU et al. (2018) Int J Lab Hematol; 40(3): 258:
Validation of reflex testing rules and establishment of a new workflow for body fluid cell analysis using a Sysmex XN-550 automatic hematology analyzer.
What we see as the essence:
The XN-550 was evaluated for body fluid analysis and the authors conclude that the XN-550 is a suitable alternative to manual body fluid analysis. In addition, several laboratory-specific cytospin review criteria were established, resulting in significant workflow improvements.
Seghezzi M et al. (2017) Clin Chim Acta; 473:133:
Preliminary evaluation of UF-5000 Body Fluid Mode for automated cerebrospinal fluid cell counting.
What we see as the essence:
The present study certifies a good agreement of the UF-5000 BF mode with manual chamber count for the parameters RBC, TNC, WBC (PMN/MN). The diagnostic performance was excellent especially in samples with few cells (RBC <1,000 cells/µL, WBC <20 cells/µL) as well as low LoB, LoD, LoQ and good linearity for CSF samples.
Fleming C et al. (2015) Clin Chem Lab Med 53(11):1689:
Clinical relevance and contemporary methods for counting blood cells in body fluids suspected of inflammatory disease.
What we see as the essence:
Excellent review on body fluid analysis. Several different analysers were compared, including the XE-5000, XN-Series and UF-Series.
Cho YU et al. (2015) Int J Lab Hematol. 37(3): 346:
Body fluid cellular analysis using the Sysmex XN-2000 automatic hematology analyzer: focusing on malignant samples.
What we see as the essence:
It was found that cell counts obtained from the XN-2000 body fluid mode were comparable to counts obtained from microscopy. The authors recommend that samples with highly fluorescent cells (HF-BF) should be further analysed.
Fleming C et al. (2012) Clin Chem Med Lab 50: 1791-1798:
Validation of the body fluid module on the new Sysmex XN-1000 for counting blood cells in cerebrospinal fluid and other body fluids.
What we see as the essence:
"The BF module on the XN-1000 is a suitable tool for fast and accurate quantification of WBC (differential) and RBC counts in CSF and other BFs in a diagnostic setting."
De Jonge R et al. (2010) Clin Chem Lab Med 48: 665–675:
Evaluation of the new body fluid mode on the Sysmex XE-5000 for counting leukocytes and erythrocytes in cerebrospinal fluid and other body fluids.
What we see as the essence:
The body fluid mode on the Sysmex XE-5000 offers rapid and accurate RBC and WBC (differential) counts in clinically relevant concentration ranges in CSF and other fluids.
Paris A et al. (2010) Int J Lab Hematol 32: 539–547:
Performance evaluation of the body fluid mode on the platform Sysmex XE-5000 series automated hematology analyzer.
What we see as the essence:
The XE-5000 count is trustworthy and can provide more precise and reliable information than the manual method using the Malassez chamber (1μL counting volume).
Riedl JA et al. (2010) J Clin Pathol 63: 538–43:
Automated morphological analysis of cells in body fluids by the digital microscopy system DM96.
What we see as the essence:
The 24 h available DM96 body fluid module reliably and accurately
preclassifies five main cell categories in cytospin slides with a low CV and an agreement of 90% as compared with highly trained technicians, thereby contributing to quality improvement.

Other Body Fluids

Xu W et al. (2016) Medicine (Baltimore);96(27):e7433:
Evaluation of Sysmex XN-1000 hematology analyzer for cell count and screening of malignant cells of serous cavity effusion.
What we see as the essence:
The analysis of serous fluid on the XN-BF mode showed good comparability with microscopy. High fluorescence cells (HF-BF) count correlated with the presence of malignant cells.
Bottini PV et al. (2015) Int J Lab Hematol.;37(2):e16:
Comparison between automated and microscopic analysis in body fluids cytology.
What we see as the essence:
The authors describe a performance evaluation of the XE-5000 body fluid mode for peritoneal and serous fluids. A good correlation between the XE-5000 and microscopy was found as well as good precision and low carryover.
Labaere D et al. (2015) Int J Lab Hematol; 37(5):715:
Detection of malignant cells in serous body fluids by counting high-fluorescent cells on the Sysmex XN-2000 hematology analyzer.
What we see as the essence:
Analysis of serous fluids on the XN-2000 showed that the absence of high fluorescence body fluid cells (HF-BF) could be used to exclude malignant samples: the negative predictive value was 92% at a cutoff of 2.1% and 95% at a cutoff of 17/µL.
Lippi G et al. (2013) J Lab Autom 2013;18(3):240:
Evaluation of the Fully Automated Hematological Analyzer Sysmex XE-5000 for Flow Cytometric Analysis of Peritoneal Fluid.
What we see as the essence:
This evaluation of the XE-5000 for peritoneal fluid analysis showed excellent performance for all analysed parameters. The performance of the XE-5000 was slightly better than that of the XE-2100.
De Jonge R et al. (2006) Clin Chem Med Lab 44: 1367–71:
Automated analysis of pleural fluid total and differential leukocyte counts with the Sysmex XE-2100.
What we see as the essence:
With some limitations, total and differential WBC counts in pleural fluid can be reliably determined using the XE-2100.
De Jonge R et al. (2004) Rheumatol 43: 170–173:
Automated counting of white blood cells in synovial fluid. Rheumatol 43: 170–173.
What we see as the essence:
The WBC count in synovial fluid using the DIFF channel of the XE-2100 can be reliably determined more precisely and faster than by manual counting. The better precision may also improve the low confidence that clinicians have in these results at present.
COVID-19

Attention - Please consider the following when assessing the literature regarding COVID-19 (SARS-CoV-2 infection)

Please consider the following when assessing the literature regarding COVID-19 (SARS-CoV-2 infection):
COVID-19 is an emerging, rapidly evolving pandemic.
Available literature is changing quickly and studies summarised here may not represent the latest status of knowledge. Please consider that conclusions of articles of this list may be based on low sample numbers or manuscripts that are not peer-reviewed yet (pre-prints).

COVID-19 and Haematology parameters

Zhou F et al. (2020) Lancet; Epub ahead of print:
Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study.
What we see as the essence:
In this study the demographics, symptoms, comorbidities and lab results of 191 COVID-19 pneumonia patients were analysed from admission until either death or discharge from hospital differentiating survivors and non-survivors. Leucocytosis and lymphocytopenia were identified as risk factors associated with death in a univariant analysis, in terms of WBC differential parameters only the lymphocyte count is given in the data.
Wang D et al. (2020) JAMA; Epub ahead of print:
Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China.
What we see as the essence:
This article summarises demographics, symptoms, comorbidities and lab results of 138 COVID-19 patients with pneumonia from one hospital in Wuhan/China by differentiating ICU and non-ICU patients. Regarding haematology parameters the total WBC, neutrophil, lymphocyte, monocyte and platelet counts are given and data about the time course of total WBC count, neutrophils and lymphocytes in survivors and non-survivors.
Liu Y et al. (2020) Sci China Life Sci; 63 (3), 364:
Clinical and Biochemical Indexes From 2019-nCoV Infected Patients Linked to Viral Loads and Lung Injury.
What we see as the essence:
The most common laboratory abnormalities were hypoalbuminaemia, lymphocytopenia, decreased LYMPH% and NEUT%, elevated C-reactive protein (CRP) and lactate dehydrogenase (LDH), and decreased CD8+ count. Age, viral load, lung injury score, albumin, CRP, LDH, LYMPH%, LYMPH#, and NEUT% may be predictors of disease severity.
Chen N et al. (2020) Lancet; 395 (10223), 507:
Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study.
What we see as the essence:
Based on 99 cases the 2019-nCoV infection is more likely to affect older males with comorbidities and can result in severe respiratory diseases. The lymphocyte count in most patients was reduced and this suggests that 2019-nCoV might mainly act on lymphocytes, especially T lymphocytes and this might be an important factor leading to exacerbations of patients.
Lippi G et al. (2020) Clin Chim Acta; 505:190:
Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis.
What we see as the essence:
The authors summarise the behaviour of procalcitonin (PCT) in COVID-19 based on data of four articles. Although viral infections do not trigger PCT it shows an odds ratio of 4.76% in severe versus mild SARS-CoV-2 infections and Lippi et al. hypothesises that bacterial co-infections are the cause and thus suggests monitoring PCT over time to allow early detection of severe cases.
Fan BE et al. (2020) Am J Hematol; 95(6): E131:
Hematologic parameters in patients with COVID-19 infection.
What we see as the essence:
In conclusion, the study showed that on admission of SARS-CoV-2 positive patients, older age, lymphocytopenia and raised LDH were associated with ICU admissions. Patients who were transferred to the ICU showed over the course of time decreasing lymphocytes, monocytes and haemoglobin counts together with increasing neutrophil counts and strongly elevated LDH levels when compared to patients who did not require ICU stay.
Liu J et al. (2020) J Transl Med; 18(1): 206:
Neutrophil-to-Lymphocyte Ratio Predicts Severe Illness Patients with 2019 Novel Coronavirus in the Early Stage.
What we see as the essence:
As of CBC parameters neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio (NLR) show significant differences between the groups of mild and severe course COVID-19 patients in this study. Based on age and NLR the authors propose a model for risk stratification and pneumonia patient management in hospital.
Lippi G et al. (2020) Clin Chem Lab Med; 58(7): 1131:
Laboratory abnormalities in patients with COVID-2019 infection.
What we see as the essence:
This letter to the editor gives an overview on laboratory abnormalities in COVID-19 patients based on 11 Chinese studies. Detailed results of eight studies are given and as haematological abnormalities of unfavourable progression increased total WBC count, increased neutrophil count and decreased lymphocyte count are mentioned.
Zheng HY et al. (2020) Cell Mol Immunol; 17(5): 541:
Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients.
What we see as the essence:
The study identified potential immunological risk factors for COVID-19 pneumonia and provided clues for its clinical treatment. In contrast to most other studies the authors did not observe increased neutrophils or decreased lymphocytes.
Qu R et al. (2020) J Med Virol; Epub ahead of print:
Platelet-to-lymphocyte ratio is associated with prognosis in patients with Corona Virus Disease-19.
What we see as the essence:
The authors suggest that the changes in the platelet-to-lymphocyte ratio (PLR) in peripheral blood during treatment could reflect the disease progression and prognosis of COVID-19 patients. In severe cases, the platelets significantly increased during treatment, which may be linked to the release of a large number of cytokines by the immune system.
Chen W et al. (2020) Emerg Microbes Infect; 9(1): 469:
Detectable 2019-nCoV viral RNA in blood is a strong indicator for the further clinical severity.
What we see as the essence:
The presence of viral RNA in the blood is positively correlated with the severe disease stage. Early monitoring of virus RNA in blood on top of the respiratory tract might be beneficial for the prediction of disease stage progression.
Lin L et al. (2020) Emerg Microbes Infect; 9(1): 727:
Hypothesis for Potential Pathogenesis of SARS-CoV-2 Infection-A Review of Immune Changes in Patients With Viral Pneumonia.
What we see as the essence:
In severe patients lymphocyte counts were significantly reduced. Non-survivors had higher levels of neutrophils, D-dimer, blood urea nitrogen and creatinine than the survivors.
Li G et al. (2020) J Med Virol; 92(4): 424:
Coronavirus infections and immune responses.
What we see as the essence:
This review article summarises the mechanisms of innate and adaptive immune response in the context of past SARS, MERS and present SARS-CoV-2 infections and thus provides insights into the pathology of COVID-19.
Osman J et al. (2020) Br J Haematol; epub ahead of print:
Rapid Screening of COVID-19 Patients by White Blood Cells Scattergrams, a Study on 381 Patients.
What we see as the essence:
A specific pattern of WDF scattergram, the “sandglass shape” pattern of lymphocyte population, was investigated in a cohort of 381 patients and exhibited a sensitivity and specificity of 85.9% and 83.5% for identifying COVID-19 infection, respectively.
Yip CYC et al. (2020) Br J Haematol; 190(1): 33:
Temporal changes in immune blood cell parameters in COVID‐19 infection and recovery from severe infection.
What we see as the essence:
The results show that CBC including extended parameters about activated lymphocytes may be a valuable tool to triage patients with COVID-19. AS-LYMP%L (as a percentage of lymphocytes) yielded the best area under the receiver operating characteristic curve for predicting severe disease.
Wang Z et al. (2020) Br J Haematol; Epup ahead of print:
High-fluorescent lymphocytes are increased in patients with COVID-19.
What we see as the essence:
A retrospective analysis of patients from the epicentre of the COVID-19 outbreak in Wuhan, China showed that while lymphocyte (L) counts were progressively decreased as disease severity increased, high-fluorescent lymphocyte (HFL) count and HFL/L ratio were increased in mild and severe cases compared to healthy controls.
Lippi G et al. (2020) QJM; 113(7): 511:
Eosinophil count in severe coronavirus disease 2019.
What we see as the essence:
The systematic literature review of data on eosinophil count in patients with COVID-19 suggest that eosinopenia may not be associated with unfavourable progression of COVID-19.
Henry BM et al. (2020) Clin Chem Lab Med; 58(7): 1021:
Hematologic, Biochemical and Immune Biomarker Abnormalities Associated With Severe Illness and Mortality in Coronavirus Disease 2019 (COVID-19): A Meta-Analysis. Clin Chem Lab Med; 58(7): 1021
What we see as the essence:
Based on 18 studies with reported laboratory data and comparison between COVID-19 patients with severe and non-severe disease the authors identified several biomarkers which may potentially aid in risk stratification for predicting severe COVID-19. The authors recommend clinicians to closely monitor WBC, LYMPH, PLT, IL-6 and serum ferritin as markers for potential progression to critical illness.
Qilin L et al. (2020) E Clinical Medicine; 23: 100375:
Eosinopenia and elevated C-reactive protein facilitate triage of COVID-19 patients in fever clinic: a retrospective case-control study.
What we see as the essence:
The combination of eosinopenia and elevated hs-CRP can effectively identify suspected COVID-19 patients from other patients attending the fever clinic with COVID-19-like initial symptoms.
Zhang C et al. (2020) Chem Lab Med; 58(7): 1152:
Decreased "WBC*LYM" was observed in SARS-CoV-2-infected patients from a fever clinic in Wuhan.
What we see as the essence:
Retrospective CBC+DIFF data analysis from a Fever Clinic in Wuhan from February 2020 (mid-Corona-pandemic in China) to evaluate the diagnostic value of haematologic parameters in suspected COVID-19 patients. The combination parameter of WBC and LYM (WBC*LYM) showed the best performance data for the quick evaluation of the patients disease severity and whether the patient is likely to have COVID-19 or not.
Woodruff MC et al. (2020) medRxiv; Epub ahead of print:
Critically ill SARS-CoV-2 patients display lupus-like hallmarks of extrafollicular B cell activation.
What we see as the essence:
Critically ill patients with COVID-19 robustly upregulate B cells producing high numbers of antibody-secreting cells. Specific B cell phenotype might serve as an immunological marker of severe COVID-19 infection at early stages.
Liua J et al. (2020) E Bio Medicine; 55: 102763:
Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients.
What we see as the essence:
In this time course study the authors confirmed lymphopenia in severe COVID-19 cases based on the decrease of CD8+ T cells but not a decrease in B cells or NK cells. The kinetics of most cytokines analysed show an inverse correlation with the T cell counts and the authors refer to a hypothesis about the function of T cells in regulating innate immune response in viral infection and thus reducing severe courses. Neutrophil-to-lymphocyte ratio (NLR) and Neutrophil-to-CD8+ T cell ratio (N8R) were identified as early indicators of severe course of COVID-19.
Gérard D et al. (2020) Br J Haematol; 189(5): 845:
SARS-CoV-2: A New Aetiology for Atypical Lymphocytes.
Fan BE et al. (2020) Am J Hematol; 95(6): 723:
COVID-19 and mycoplasma pneumoniae coinfection.
Foldes D et al. (2020) Am J Hematol; 95(7): 861:
Plasmacytoid lymphocytes in SARS-CoV-2 infection (Covid-19).
Mitra A et al. (2020) Am J Hematol; Epub ahead of print:
Leukoerythroblastic Reaction in a Patient With COVID-19 Infection.

COVID-19 and haemostasis parameters

Jecko Thachil et al (2020): (2020) Prelease from jth. Online version:
ISTH interim guidance on recognition and management of coagulopathy in COVID‐19.
What we see as the essence:
The ISTH interim guidance recommends measuring D-dimer, prothrombin time and platelet count in all patients suspected of having a COVID-19 infection, to decide whether patient admission and close monitoring is necessary or not. For a better and easy understanding, an algorithm to manage the COVID-19 coagulopathy based on simple laboratory markers is proposed in the appendix of the document. The authors also encourage measuring fibrinogen in COVID-19 positive patients, as recommended by the ISTH guidance on disseminated intravascular coagulation (DIC). Finally, the publication gives some advice on the use of LMWH treatment of COVID-19 positive patients.
Tang et al (2020) Prelease from jth. Online version:
Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy.
What we see as the essence:
This publication is investigating the contribution of heparin to surviving COVID-19 associated complications such as disseminated intravascular coagulopathy (DIC) or venous thromboembolism (VTE). 449 patients tested positive for COVID-19 were enrolled in this study in which 22% received heparin (mainly LMWH) treatment. The heparin treatment is associated with lower mortality in patients with a sepsis-induced coagulopathy (SIC) score ≥ 4, but not in those with a SIC score < 4. The mortality of patients with a D-dimer level > 3 μg/L was up to 20 % lower in heparin users than in non-users. Generally, increasing levels of D-dimer and PT (sec.) correlated with a higher 28-day mortality, while higher platelet counts correlated with a lower mortality.
Lippi et al. (2020) Clinica Chimica Acta 506 (2020):145–148:
Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A metaanalysis.
What we see as the essence:
A low platelet count is associated with an increased risk of severe disease and mortality in patients with COVID-19.
Han et al (2020) Clinical Chemistry and Laboratory Medicine (CCLM):
Prominent changes in blood coagulation of patients with SARS-CoV-2 infection.
What we see as the essence:
This paper presents the result of a comparison of prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), antithrombin (AT), D-dimer and fibrin degradation products (FDP) in patients with SARS-CoV-2 (COVID-19) compared with a healthy population. Patients with COVID-19 were subdivided into three groups: mild, severe and critical. APTT and TT showed no significant differences between patients with COVID-19 and the control group. PT activity (%) and AT were lower in the COVID-19 group, with a descending tendency at an increasing level of the disease, but mostly remained within the reference ranges. FIB was elevated in COVID-19 patients at an equal level, regardless of the severity of the disease. D-dimer and FDP increased with the severity of the disease, with values generally appearing higher than in the control group.
Chaomin Wu et al (2020) JAMA Intern Med. Published online:
Risk Factors Associated with Acute Respiratory Distress Syndrome and Death in Patients with Coronavirus Disease 2019 Pneumonia in Wuhan, China.
What we see as the essence:
The publication reveals the results of a retrospective cohort study of 201 patients with confirmed COVID-19 pneumonia admitted to Wuhan Jinyintan Hospital. Elevated prothrombin time (PT) and D-dimer results were significantly associated with higher risks of developing Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS who died later in the course of the disease presented significantly higher D-dimer levels than patients with ARDS who survived. In contrast to this, anomalies in PT were not associated with higher death rates in ARDS patients.
Tang et al (2020) J Thromb Haemost. 2020; 00:1–4.:
Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia.
What we see as the essence:
Coagulation tests prothrombin time (PT), activated partial thromboplastin time (APTT), antithrombin activity (AT), fibrinogen (FIB), fibrin degradation product (FDP), and D-dimer were determined from 183 patients with confirmed novel coronavirus pneumonia (NCP, COVID-19) admitted to Tongji Hospital. Coagulation tests were performed in three-day intervals for 14 days in total. The non-survivors revealed significantly higher D-dimer and FDP levels, longer PT (sec.) and significantly lower AT levels compared with survivors on admission. A decrease in fibrinogen levels in non-survivors was found on days 10 and 14. DIC, mostly due to virus sepsis, appeared in most of the non-survivors.
Dawei Wang et al (2020) JAMA. 2020; 323(11):1061-1069.:
Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus – Infected Pneumonia in Wuhan, China.
What we see as the essence:
This publication reveals the results of a retrospective, single-centre case study of 138 consecutively hospitalised patients with confirmed novel coronavirus pneumonia (NCP). The level of D-dimer is a promising prognostic marker for survival of the disease, with higher survival rates in patients with low D-dimer levels compared with those having high D-dimer levels.
Fei Zhou et al (2020) THE LANCET. Volume 395, Number 10229, p1011-1088, e54-e61:
Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study
What we see as the essence:
This release presents the findings of 191 patients tested positive for COVID-19. The most frequently observed complication was sepsis. Most of the patients had an increased coagulation activity marked by elevated D-dimer concentrations. Found in most of the inpatients, this finding was associated with a higher mortality with increasing D-dimer levels at admission. Elevated prothrombin time (PT, sec.) results were not strongly associated with the disease or its outcome.
Suxin Wan et al (2020) Prelease from JOURNAL OF MEDICAL VIROLOGY. Online version.:
Clinical Features and Treatment of COVID-19 Patients in Northeast Chongqing
What we see as the essence:
This publication describes the clinical and laboratory presentation of 135 patients tested positive for COVID-19. All patients had elevated D-dimer levels. Patients with a severe presentation of the disease had higher levels of D-dimer than patients with a mild form. Other haemostasis parameters were mostly within their normal ranges, but prothrombin time (PT, sec.) and activated partial thromboplastin time (APTT, sec.) were higher in patients with a severe form of the disease than in patients with a mild form.
Yong Gao et al (2020) JOURNAL OF MEDICAL VIROLOGY. Online version:
Diagnostic Utility of Clinical Laboratory Data Determinations for Patients with the Severe COVID-19.
What we see as the essence:
The study presents the results of investigations made on 43 adult patients tested positive for COVID-19 and which aimed at looking for a warning index for severe patient cases. Most patients presented with a mild form of the disease. Prothrombin time (PT) and activated partial thromboplastin time (APTT) levels were not significantly different between mild and severe cases. Thrombin time (TT), fibrinogen (FIB) and D-dimer levels were higher in patients with severe disease presentation than in those with mild cases. The study suggests interleukin-6 (IL-6) and D-dimer level determination having the highest specificity and sensitivity for an early prediction of severe clinical presentations of COVID-19.
Dolhnikoff et al (2020) Pathological evidence of pulmonary thrombotic phenomena in severe COVID-19.:
Prelease from jth. Online version first published: 15 April 2020.
What we see as the essence:
This letter to the editor refers to recently published findings in COVID-19-positive patients and gives new insights into the relation between COVID-19 and DIC based on autopsy results. A variable number of small fibrinous thrombi in small pulmonary arterioles in areas of both damaged and more preserved lung parenchyma have been found in eight out of the ten investigated fatal cases. Other indications of hypercoagulative processes found in these cases were endothelial tumefaction and a large number of pulmonary megakaryocytes in the pulmonary capillaries, as well as – in rare cases – small fibrinous thrombi in the glomeruli and superficial dermal vessels.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, blood coagulation, coagulopathy, autopsy.
Klok et al (2020) Incidence of thrombotic complications in critically ill ICU patients with COVID-19.:
Prelease from Thrombosis Research. Online version first published: 10 April 2020.
What we see as the essence:
The publication presents the result of evaluating the incidence of the combined outcome of venous thromboembolism (VTE) and arterial thrombotic complications in all COVID-19 patients admitted to the intensive care unit of two Dutch university clinics and one Dutch teaching hospital. In total, 184 patients with proven COVID-19 pneumonia admitted to the ICU have been studied. The majority of patients were still on the ICU at the time the study ended, whereas 23 (13 %) died. All patients received at least standard doses of thromboprophylaxis. Most frequently found VTE was pulmonary embolism (PE). Prolongation of prothrombin time (PT, sec.) and activated partial thromboplastin time (APTT, sec.) are considered as independent predictors of thrombotic complications. Pharmacological thrombosis prophylaxis is recommended for all COVID-19 patients admitted to the intensive care unit, with an increase in doses from prophylactic to highly prophylactic ones.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, blood coagulation, coagulopathy, pulmonary embolism, deep vein thrombosis, stroke, thromboprophylaxis.
Brandon Michael Henry, Giuseppe Lippi et al (2020) Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis.:
Published at Clinical Chemistry and Laboratory Medicine (CCLM), 20200369, eISSN 1437-4331, ISSN 1434-6621. First published online: 10 April 2020.
What we see as the essence:
This publication analysed the findings of a total of 21 studies. Overall, the laboratory findings of 2,984 COVID-19 patients from 18 studies are compared between those with severe and with non-severe presentation of the disease. Additionally, the laboratory findings of three studies with 393 patients are compared between patients who survived and those who did not. Prothrombin time (PT) and D-dimer are elevated in patients with severe or fatal COVID-19. Non-survivors had more significant decreases in lymphocyte and platelet counts compared with survivors.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, blood coagulation, clinical chemistry.
Manalo IF, Smith MK, Cheeley J, Jacobs R (2020) A Dermatologic Manifestation of COVID-19: Transient Livedo Reticularis. Online pre-release at JAAD.:
Online version first published: 10 April 2020.
What we see as the essence:
This publication suspects that micro thromboses manifested in organs and as disseminated intravascular coagulation (DIC) in critically ill COVID-19 patients causes livedo reticularis (LR). Two cases of transient LR, from which the patients recovered fully, are reported. This finding of LR seems to be different to SARS-CoV and MERS-CoV. Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, livedo reticularis, disseminated intravascular coagulation.
Terpos et al (2020) Hematological findings and complications of COVID-19. Online pre-release at American Journal of Hematology.:
Online version first published: 13 April 2020.
What we see as the essence:
This review article highlights clinical and laboratory presentation of COVID-19 patients to give guidance for early prevention and management of the disease. Signs of major blood hypercoagulability, namely elevated levels of D-dimer, FDP, activated partial thromboplastin time (APTT) and prothrombin time (PT), as well as a reduced activity of antithrombin were commonly found in patients with COVID-19. The levels of D-dimer and FDP are significantly higher in non-survivors than in survivors. Careful evaluation of laboratory indices at baseline and throughout the course of the disease is advised for a tailored, efficient treatment and thromboprophylaxis, contributing to the survival rate of the affected patients.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, coagulation.
Hussain et al (2020) COVID-19 and Diabetes: Knowledge in Progress. Published at Diabetes Research and Clinical Practice. Volume 162, April 2020, 108142.:
First published online: 9 April 2020.
What we see as the essence:
This review article summarises the findings of publications about COVID-19 and diabetes. Some studies did not find a clear association between diabetes and severity of the disease while others indicated that older patients with chronic diseases including diabetes were at higher risk of severe COVID-19 courses and mortality. SARS-CoV-2 possibly triggers higher stress conditions in patients with diabetes, with a greater release of hyperglycaemic hormones leading to increased blood glucose levels and abnormal glucose variability. Around 10% of the patients with type-2 diabetes mellitus and COVID-19 suffered at least one episode of hypoglycaemia (< 3.9 mmol/L), causing the mobilisation of pro-inflammatory monocytes and an increase of platelet reactivity. These conditions contribute to a higher cardiovascular mortality in patients with diabetes. Besides the inflammatory processes, an imbalance between coagulation and fibrinolysis occurs, with increased levels of clotting factors and relative inhibition of the fibrinolytic system. Both insulin resistance and type-2 diabetes mellitus are associated with endothelial dysfunction, and enhanced platelet aggregation and activation. In addition to atherosclerosis, vascular inflammation and endothelial dysfunction, these abnormalities contribute to the development of a hypercoagulable pro-thrombotic state.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, diabetes, coagulopathy, coagulation.
Songping Cui, Shuo Chen et al (2020) Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia. Prelease from jth. Online version.:
First published: 9 April 2020.
What we see as the essence:
This publication reveals the incidence of VTE in a retrospective study of 81 patients tested positive for COVID-19 at Union Hospital, Wuhan over a period of nearly two months. 25 % of patients with a severe presentation of COVID-19 developed a deep venous thrombosis in their lower limbs. Higher age, lower lymphocyte counts, prolonged activated partial thromboplastin time (APTT) and elevated D-dimer levels have been reported in these patients frequently. Even though D-dimer levels were above the normal range in both VTE and non-VTE patients, D-dimer was elevated to a remarkably higher extent in VTE patients. The incidence of DIC in non-survivors was 71.4 %, suggesting that abnormal blood coagulation and thrombosis are associated with poor prognosis in patients with COVID-19. Furthermore, the paper implies to increase the D-dimer cut-off level to predict VTE in COVID-19-positive patients.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, D-dimer, coagulopathy, coagulation, venous thromboembolism.
Wang et al (2020) Tissue Plasminogen Activator (tPA) Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Case Series. Prelease from jth. Online version.:
First published: 8 April 2020.
What we see as the essence:
This publication reports utility of tissue plasminogen activator (t-PA, Alteplase) in three cases of critically ill, mechanically ventilated COVID-19-positive patients with ARDS and respiratory failure. All three cases showed initial improvement of the respiratory conditions. However, the improvements were transient only, and the respiratory conditions of all patients deteriorated after terminating the tPA therapy. The paper concludes that the utility of larger bolus tPA (with or without anticoagulation) to prevent the recurrence of suspected pulmonary microvascular thrombosis in COVID-19 ARDS should be investigated in further studies.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, Tissue Plasminogen Activator (tPA), fibrinolysis, coagulation, Acute Respiratory Distress Syndrome (ARDS).
Shiyu Yin, Ming Huang, Dengju Li, Ning Tang (2020) Difference of coagulation features between severe pneumonia induced by SARS-CoV2 and non-SARS-CoV2. Published at J Thromb Thrombolysis. Online version.:
First published: 3 April 2020.
What we see as the essence:
This publication investigates the differences of coagulation features between severe pneumonia induced by SARS-CoV-2 and non-SARS-CoV-2. Four hundred and forty-nine patients classified as a COVID group, and 104 patients classified as a non-COVID group were enrolled in this study. Compared with the non-COVID group, patients of the COVID group were older, had higher platelet counts, and their mortality was almost twice as high. In patients with D-dimer levels exceeding the upper normal limit sixfold, a significantly lower mortality among heparin (mainly LMWH) users than among non-users was found in the COVID group, while no difference in the mortality between heparin users and non-users could be found in the non-COVID group when being stratified by D-dimer. However, anticoagulant therapy may not benefit unselected patients, whether in the COVID or non-COVID group.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, D-dimer, coagulopathy.
Yulong Zhou, Zhicheng Zhang, Jie Tian, Shaoyun Xiong (2020) Risk factors associated with disease progression in a cohort of patients infected with the 2019 novel coronavirus. Published at Ann Palliat Med 2020; 9(2):428-436.:
First published: 22 March 2020.
What we see as the essence:
The clinical presentation of 17 patients tested positive for COVID-19 has been reported in this publication. While fever and cough were reported most frequently, dyspnoea and fatigue were rarer, and none of the patients had diarrhoea. The publication could not reveal any difference in D-dimer levels between patients with a worsening condition and stable patients. In contrast to this, significantly decreased total lymphocyte counts were found in patients with a worsening condition.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, D-dimer, coagulopathy.
Weina Guo, Mingyue Li et al (2020) Diabetes is a risk factor for the progression and prognosis of COVID‐19. Published at Diabetes Metab Res Rev. 2020; e3319.:
First published: 31 March 2020.
What we see as the essence:
This publication is a retrospective study of 174 patients with SARS-Cov-2 infection who were admitted to Wuhan Union hospital from 10 February 2020 to 29 February 2020. Patients with diabetes were at higher risk of severe pneumonia, the release of tissue injury-related enzymes, excessive inflammation response, and hypercoagulable state associated with dysregulation of glucose metabolism. D-dimer levels were significantly higher in patients with type 2 diabetes mellitus than in those without.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, D-dimer, diabetes.
Taisheng Li, Hongzhou Lu and Wenhong Zhang (2020) Clinical observation and management of COVID-19 patients. Published at Emerging Microbes & Infections 2020, vol. 9, issue 1, pages 687-690.:
First published online: 25 March 2020.
What we see as the essence:
In this publication, three leading infectious disease experts in China share their observations in the management of COVID-19 patients. In the clinical course of the disease and with a worsening of the symptoms, D-dimer values increased from mildly to significantly elevated, along with prolonged prothrombin time (PT), and a gradual decrease of fibrinogen (FBG) and platelets. The clinical and laboratory manifestations are consistent with the diagnosis of the hypercoagulable phase of DIC. It is assumed that COVID-19 can activate the coagulation cascade through various mechanisms, leading to severe hypercoagulability. Low molecular weight heparin (LMWH) treatment may prevent further clot formation and reduce microthrombi. Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, coagulopathy, low molecular weight heparin, clinical management, antiviral drugs.
Zhang et al (2020) D‐dimer levels on admission to predict in‐hospital mortality in patients with Covid‐19. Prelease from jth. Online version.:
First published: 19 April 2020.
What we see as the essence:
Based on the outcome of 343 patients tested positive for COVID-19 and their survival rate, this publication recommends using a higher cut-off value for D-dimer to predict the mortality of patients on hospital admission. The authors state to use a cut-off four times higher than the cut-off recommended by the reagent manufacturer for the exclusion of VTE in patients. Patients with a D-dimer result above this COVID-19 D-dimer cut-off have a higher mortality than patients with a D-dimer level below it.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, D-dimer, mortality, prognosis, CS-5100.
Chuen Wen Tan et al (2020) Critically Ill COVID-19 Infected Patients Exhibit Increased Clot Waveform Analysis Parameters Consistent with Hypercoagulability. Prelease from AJH. Online version.:
First published: 08 April 2020.
What we see as the essence:
The letter to the editor shares the outcome of the clot waveform analysis (CWA) evaluation of the APTT results from three patients tested positive for COVID-19 and admitted to the ICU. None of the patients had an underlying malignancy, bleeding or thrombotic disorder, nor were they under antithrombotic therapy on admission. The APTT values were moderately prolonged. The author indicates that there is a relation between the increase of the CWA parameter and a worsening of the severity of the COVID-19 infection. Furthermore, differences in the CWA parameter between COVID-19 and other viral or bacterial infections are reported.
Keywords: Corona Virus Disease 2019, SARS-CoV-2, COVID-19, clot waveform analysis (CWA), CS-2100, CS-2500.

COVID-19: Urinalysis

Wu et al. (2020) Journal of Urology 204:1-2:
Focus on the crosstalk between COVID-19 and the urogenital systems.
What we see as the essence:
This short editorial comment reflects the potential effects of the SARS-CoV-2 infection on urogenital systems. SARS-CoV-2 utilises the ACE2-receptor (ACE2 = angiotensin-converting enzyme II) for entering target cells. The ACE2-receptor is also expressed on cells of the proximal renal tubule, the bladder urothelial and cells of the male reproductive system.
In summary, more attention should be paid on COVID-19 patients with chronic urological histories, as comorbid conditions, such as chronic kidney disease and urological malignancies contribute to a weaker immune system, increasing the risk to be infected by SARS-CoV-2.
Liu et al. (2020) Clin Chem Lab Med 58(7):1121-1124:
The value of urine biochemical parameters in the prediction of the severity of the corona virus disease 2019.
What we see as the essence:
The authors of this study aimed to evaluate the potential urine biochemistry parameters in predicting disease severity in addition to diagnosis by viral nucleic acid test and auxiliary haematology diagnostic parameters. The relationship between urinalysis parameters and COVID-19 disease severity were investigate on 119 patients at Wuhan University Hospital grouping patients according to disease severity into healthy, moderate, severe and critical.
In general, COVID-19 patients showed haematuria and proteinuria, increased pH values and decrease specific gravity, if compared to healthy individuals. Within the population of COVID-19 patients, urinary glucose and protein levels were significantly higher within the severe and critical cohorts. Other urine biochemistry parameters seemed not to be related to the severity of COVID-19.
In conclusion, some urinary are parameters might complement the differentiation between healthy and COVID-19-positive individuals and urinary glucose and protein levels might be suitable parameters to distinguish between different stages of disease severity.
Bonetti et al. (2020) Clin Chem Lab Med:aop:
Urinalysis parameters for predicting severity in coronavirus disease 2019 (COVID-19).
What we see as the essence:
Inspired by Liu et al. and the potential use of urinalysis parameters in discrimination of the COVID-19 disease severity, the authors of this study provide a deeper insight into urinalysis parameters and their potential for accurate risk stratification of progressing toward severe or critical disease, especially as the urinary tract is commonly involved in COVID-19 infections.
From 226 patients admitted to the emergency department for COVID-19, 45 patients showed a more severe condition from CT imaging and were in the emergency department and included in this study. Urinalysis was carried out using Aution Max AX-4030 and SediMax systems. Patients with a history of diabetes or kidney disease were excluded.
All 226 COVID-19-positive patients showed proteinuria and haematuria at point of admission. In addition, urine sediment analysis revealed the presence of erythrocytes and casts in nearly half of all patients. Comparing the two study cohorts ‘In-hospital deaths’ and ‘Discharged’
Showed a more frequent presence of granular cylinders and tubular cells in the urine of patients who died. Higher abnormal rates of urea and creatinine values reflected renal impairment, which might be a significant predictor of an unfavourable disease progression.
In conclusion, urinalysis should be regularly performed in all COVID-19 patients to obtain additional information for optimisation of patient management and risk prediction.
Gross et al. (2020) Lancet 395:87-88:
COVID-19-associated nephritis: early warning for disease severity and complications?
What we see as the essence:
Since SARS-CoV-2 uses the ACE2 receptor to enter its target cells, also renal podocytes are a potential target of this corona virus. In concordance with post-mortem analysed histopathology samples that showed glomerular injury and nephritis-like histology, SARS-CoV-2 infections can induce nephritis.
Nephritis can cause a severe course of infection by inducing a capillary leak syndrome, a systemic condition in which plasma fluid and proteins leak from capillary vessels into the surrounding tissue. This results in hypotension, hypoalbuminemia and a reduced haemoconcentration, finally leading to respiratory decompensation that requires ICU admission and ventilation.
In this correspondence, the authors conclude that analysis of urine specimens at the point of hospital admission for COVID-19 patients could help to identify patients with a COVID-19-associated nephritis and the risk for respiratory decompensation. The risk for these patients is elevated, if two or three conditions of leucocyturia, albuminuria or haematuria are fulfilled.
Henry and Lippi (2020) Int Urol Nephr 52:1193-1194:
Chronic kidney disease is associated with a severe coronavirus disease 2019 (COVID-19) infection.
What we see as the essence:
Since chronic Kidney disease (CKD) is associated with an increased risk of both inpatient and outpatient pneumonia, causing an 14 to 16-fold increase in the mortality rate in CKD patients seems to be 14–16, the authors conducted a meta-analysis to explore the potential association between CKD and severity of the COVID-19 infection.
A meta-analysis was performed on retrievable data, including the estimation of the odds ratio (OR) and its 95% confidence interval (95% CI) in patients with or without severe forms of COVID-19.
Finally, four studies were included, including 1389 COVID-19 patients, among which 273 (19.7%) were classified as having severe disease. Although no study individually found CKD as significant clinical predictor, the meta-analysis revealed a significant association of CKD with a severe course of COVID-19 infection.
In conclusion, CKD seems to be associated with enhanced risk of severe COVID-19 infection.
Cheng Y et al. (2020) Kidney International 97:829-838:
Chronic kidney disease is Kidney disease is associated with in-hospital death of patients with COVID-19.
What we see as the essence:
This study prospectively investigated the link between renal involvement and observed mortality rate. Out of 701 patients, hospitalised for COVID-19, 43.9 % showed proteinuria and 26.7 % showed haematuria. Furthermore, increased prevalence for increased creatinine and urea levels and reduced glomerular filtration rates were observed.
The authors conclude that these parameters are independent risk factors for morbidity and that renal damage is a major complication in COVID-19.
Selby et al. (2020) BMJ 369:m1963:
COVID-19 and acute kidney injury in hospital: summary of NICE guidelines.
What we see as the essence:
Acute kidney injury (AKI) is observed in a subset of COVID-19 patients, significantly increasing the risk of mortality. AKI can occur at all stages of COVID-19 infection, demanding clinical vigilance and consideration of risk factors for AKI alongside early detection and diagnosis are essential components of general supportive care.
This article summarises key points from the National Institute for Health and Care Excellence (NICE) COVID-19 rapid guideline on AKI in hospital.
Oncology

Digital pathology

Fu et al. (2017) Diagnostic Pathology:
Evaluation of a confocal WSI scanner for FISH slide imaging and image analysis
What we see as the essence:
A study on 14 FISH slides scanned with confocal and wide field microscopy on a 3D Histech Pannoramic Scanner System showed that confocal imaging provides sharper images. Confocal multi-layer scanning is supposed to be the future application tool for FISH imaging.
Paulik R et al. (2017) Cytometry Part A:
An Optimized Image Analysis Algorithm for Detecting Nuclear Signals in Digital Whole Slides for Histopathology
What we see as the essence:
A new 3D Histech algorithm for image analysis optimized for whole slide quantification of nuclear immunostaining signals of ER, PR, and Ki-67 proteins in breast cancers was tested against two other open source applications. The new algorithm outcompeted the comparators for histopathological evaluation of breast cancer biomarkers in accurately detecting nuclear signals of predictive and prognostic biomarkers (ER, PR, Ki-67) as well as fluorescent DAPI labeled cell nuclei and higher processing speed.
Paulik R et al. (2017) Cytometry Part A:
An Optimized Image Analysis Algorithm for Detecting Nuclear Signals in Digital Whole Slides for Histopathology
What we see as the essence:
A new 3D Histech algorithm for image analysis optimized for whole slide quantification of nuclear immunostaining signals of ER, PR, and Ki-67 proteins in breast cancers was tested against two other open source applications. The new algorithm outcompeted the comparators for histopathological evaluation of breast cancer biomarkers in accurately detecting nuclear signals of predictive and prognostic biomarkers (ER, PR, Ki-67) as well as fluorescent DAPI labeled cell nuclei and higher processing speed.
Nolte et al. (2017) The Journal of Pathology: Clinical Research:
Construction and analysis of tissue microarrays in the era of digital pathology: a pilot study targeting CDX1 and CDX2 in a colon cancer cohort of 612 patients
What we see as the essence:
Several investigated parameters indicate that CDX2 performs more robustly than CDX1 in terms of applicability. Our projected results show that (1) ngTMA is highly accurate and leads to a low frequency of tissue core loss, (2) different types of tumour heterogeneity can be investigated using the combined ngTMA-DIA workflow and (3) low percentages of CDX1 and CDX2 positive cells are associated with more aggressive tumour biology and the influence of different staining intensities on patient selection is much lesser in CDX2 than in CDX1.
Goos J. et al. (2016) Annals of Surgery:
Glucose Transporter 1 (SLC2A1) and Vascular Endothelial Growth Factor A (VEGFA) Predict Survival After Resection of Colorectal Cancer Liver Metastasis
What we see as the essence:
During this investigation Tissue microarrays (TMA) were produced by using colorectal cancer (CRC) liver metastasis and patient-matched primary CRC. TMA covers every step of the digital TMA workflow from sample designation/slide preparation from the donor block to the final evaluation of the TMA project using TMA software solutions.
Zlobec I. et al. (2014) Journal of Visualized Experiments:
A Next-generation Tissue Microarray (ngTMA) Protocol for Biomarker Studies
What we see as the essence:
“Tissue microarrays (TMA) are produced by repeated transfer of small tissue cores from a ‘donor’ block into a ‘recipient’ block and then used for a variety of biomarker applications. In this study a procedure using next-generation Tissue Microarrays (ngTMA) is decribed. ngTMA uses a protocol based on TMA planning and design, digital pathology and automated tissue microarraying. Due to its precision, flexibility and speed, ngTMA is a powerful tool to further improve the quality of TMAs used in clinical and translational research.”
Nap M. et al. (2012) APMIS:
A travel report of the implementation of virtual whole slide images in routine surgical pathology
What we see as the essence:
This study provides an extensive overview about virtual microscopy and its implementation in the daily routine.
Fónyad L. et al. (2012) Diagnostic Pathology:
Validation of diagnostic accuracy using digital slides in routine histopathology
What we see as the essence:
“Digital microscopy: a study designed to evaluate the scanning properties and digital slide based diagnostic accuracy. The study results reveal that digital slide based histopathological diagnoses can be highly coherent with those using optical microscopy, that the competency of pathologists is a factor more important than the quality of digital slide and that poor digital slide quality do not endanger patient safety as these errors are recognizable by the pathologist and further actions for correction could be taken.”
Varga VS. et al. (2012) Stud Health Technol Inform.:
Automated high throughput whole slide imaging using area sensors, flash light illumination and solid state light engine
What we see as the essence:
This article deals with the technical background and conclusion behind engineering decisions made during the development of 3DHISTECH's 3rd generation combined brightfield and fluorescent scanner. By applying the current camera technology and standard microscope optical components, a high throughput and high quality whole slide imaging is feasible which meets all demands for most of the routine diagnostic work.
Rossing HH. et al. (2012) Wiley Online Library:
Implementation of TMA and digitalization in routine diagnostics of breast pathology
What we see as the essence:
This study demonstrates that in breast cancer routine diagnostics the application of Tissue microarrays (TMA) combined with digitalization of the stained multi-slides is more economical, less time consuming and therefore accompanied with a considerable cost reduction. In the daily diagnostics this tool also improves standardization of tumour profiling.

Faecal immunochemical test for colorectal cancer screening

Brenner H. et al. (2017) International Journal of Cancer:
Strong subsite-specific variation in detecting advanced adenomas by fecal immunochemical testing for haemoglobin
What we see as the essence:
FOB-Gold was applied prior to colonoscopy by 3.466 participants of the German screening colonoscopy program. The goal was to proof the subsite specific sensitivity for various types of colorectal neoplasms by comparing FIT results with findings at screening colonoscopy. The iFOBT FOB-Gold showed a sensitivity of 95-100% and therefore an excellent performance in detecting CRC.
Toes-Zoutendijk E. et al. (2017) Gastroenterology:
Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels
What we see as the essence:
Data were collected from the first year of the Dutch screening program (2014) with biennial FITs by real-time monitoring (529.056 people participating). Because of the higher than predicted positivity rate (10.6%) and the lower PPV (42.1%) after some months the FOB-Gold test cut-off was increased (from 15 to 47 µg Hb/g feces), resulting finally in 6.7% positivity rate and 49.1% PPV. It has been concluded that for optimization of screening performance (test cut-off adjustments) a close monitoring of the implementation program is needed.
(2016) National Institute for Public Health and the Environment (RIVM):
Erasmus MC Rotterdam, NKI/Antoni van Leeuwenhoek COLORECTAL CANCER SCREENING PROGRAMME • Monitor 2014, 2015, 2016
What we see as the essence:
RIVM commissioned Erasmus MC and the Netherlands Cancer Institute (NKI)/Antoni van Leeuwenhoek Hospital to carry out national monitoring of the CRC screening programme on an annual basis. Considering the first screening rounds in all 3 years participation rates (~71-73%) were quite similar. The same was valid for positivity and detection rates for advanced neoplasia (AN). During the second round in 2016 an increase in participation rate was visible and not unexpected, the positivity and detection rates and PPV decreased compared to the first round. This is based on the fact that the prevalence of AN normally decreases after the first rounds of screening.
Dancourt V. et al. (2016) European Journal of Cancer Prevention:
Influence of sample return time and ambient temperature on the performance of an immuno-chemical faecal occult blood test with a new buffer for colorectal cancer screening
What we see as the essence:
Investigation on the effects of sample return time and of season on the FOB-Gold performance with a new buffer (study included 20.371 participants from French SP). The positivity rates were 4.1, 4.1 and 4.6% for a sample return time of up to 3 days, 4-5 days and 6-7 days. At 20°C there was a decrease in Hb concentration of 5.1% after 7 days, at 30°C of 20.5%. As result at 20°C after 7 days 100% of the samples of participants with CRC (4/4) and 97% of samples of participants with advanced adenomas (38/39) remained positive. It was concluded that a delay in sample return and season did not affect the diagnostic yield of FOB-Gold.
Grobbee E.J. et al. (2016) Gut:
A randomised comparison of two faecal immuno-chemical tests in population-based colorectal cancer screening
What we see as the essence:
Comparison of two iFOBTs (FOB-Gold and OC-Sensor) on Dutch screening population (n=19.291; 60-74 years old). Both iFOBTs were equally acceptable to the participants. The test performance regarding detection of colorectal advanced neoplasia was comparable for both tests, as well as the positive predictive value. In conclusion, the OC-Sensor and FOB-Gold perform similar in population-based screening.
Chen H. et al. (2016) Clinical Gastroenterology and Hepatology:
Fresh vs Frozen Samples and Ambient temperature have Little Effect on Detection of Colorectal Cancer or Adenomas by a Fecal Immunochemical Test in a Colorectal Cancer Screening Cohort in Germany
What we see as the essence:
Comparison of detection of CRCs and colorectal neoplasms by FOB-Gold using fresh samples vs frozen samples and assessment of the influence of seasonal variations (temperatures) on test performance. 3.466 FIT sample results from the German colonoscopy screening program were assessed. 12.8% of frozen stool samples and 8.7% of fresh stool samples had positive results by FIT. After adjusting the test cut-off to achieve the same %age of positive results, both sample cohorts showed similar levels of sensitivity and specificity for colorectal neoplasms. In addition no differences in detection of neoplasms during different seasons (different outdoor temperatures) were observed. It has been concluded that the use of fresh vs frozen samples only slightly affected positivity rates at the recommended test cut-off.
Dvir R. et al. (2016) United European Gastroenterology Journal:
SENTIFIT 270 SYSTEM CLINICAL PERFORMANCE EVALUATION COMPARED WITH OC SENSOR DIANA, FOR THE DETECTION OF HUMAN HAEMOGLOBIN AS FAECAL OCCULT BLOOD (FOB)
What we see as the essence:
The study goal was to compare the clinical performances of SENTiFIT FOB-Gold (SENTiFIT270 system) with the OC-SENSOR DIANA system. A good concordance between the SENTiFIT and the DIANA assay was observed: SENTiFIT assay is a valid quantitative FIT.
Poster Presentation Soliera A.R. et al. (2014) IFCC WorldLab Istanbul:
Automated Faecal Imunoassay Testing (FIT) for Hemoglobin on a new dedicated analyzer
What we see as the essence:
The SENTiFIT® 270 system with SENTiFIT® pierceTube for the quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy.
Poster Presentation Correale M. et al. (2014) IFCC WorldLab Istanbul:
SENTiFIT® - FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer
What we see as the essence:
The SENTiFIT® 270 system with SENTiFIT® pierceTube for the immunochemical quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy. The system is user friendly and easy to use. The new, pierceable sample tube improves the measurement accuracy, reduces the input and leads to a complete automation of the FIT.
Gnatta E. et al. (2014) Clin Chem Lab Med:
A new sampling device for faecal immuno-chemical testing: haemoglobin stability is still an open issue
What we see as the essence:
Evaluation of the Hb stability in faeces collected with FOB-Gold Tube Screen and Tube NG that contain different buffers (buffer H, BH). 15 true positive samples were collected with both buffers, portioned and incubated at 4, 21 and 32°C for 10 days. Endpoint was the percentage of cumulative faecal Hb decrease (HbCD%). The results showed that no significant difference was visible between BH and BN in HbCD% at 4°C. At 21 and 32°C the HbCD% was lower in BH than in BN samples whereas no difference was found between samples stored in BH at 4 and 21°C.
Anelli MC. et al. (2014) AACC ANNUAL MEETING & CLINICAL LAB EXPO (Chicago):
SENTiFIT®-FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer in CoreLab at the AUSL Modena Nuovo S.Agostino Estense hospital in Emilia Romagna Region
What we see as the essence:
The aim of this study was to compare two quantitative FITs: SENTiFIT270 and OC-Sensor Diana. Both systems showed a high concordance (95.8%), sensitivity (100%) and specificity (95.2%).
Hamza S. et al (2013) European Journal of Cancer:
. Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer
What we see as the essence:
The objective target of this evaluation was to check the performance of the quantitative immunochemical test FOB-Gold and to propose a possible strategy for an organized screening programme. Result of this study: a one-sample strategy is preferred and with a recommended cut-off, the overall positivity rate would be manageable in EU countries.
Faivre J. et al. (2012) European Journal of Cancer:
Comparison between a guaiac and three immunochemical faecal occult blood tests in screening for colorectal cancer
What we see as the essence:
The objective of this study was to evaluate a guaiac-based (G-) FOBT (Hemoccult-II) versus 3 immunochemical (I-)FOBTs (FOB-Gold, OC-Sensor, Magstream) within the French population-based organized screening programme. The study outcome reveals additional proof that I-FOBTs are superior to the selected G-FOBT whereas none of the 3 applied I-FOBTs pointed out any significant performance advantages towards the others.
Faivre J. et al. (2012) Digestive and Liver Disease:
Positivity rates and performances of immunochemical faecal occult blood tests at different cut-off levels within a colorectal cancer screening programme
What we see as the essence:
The goal of this study was to investigate the following approaches: on the one hand a 2-sample strategy with at least one positive test and on the other hand a 1-sample strategy implying various cut-off values for one of the two I-FOBTs (FOB-Gold or OC-Sensor) performed in combination with a G-FOBT (Hemoccult-II). It turned out that using I-FOBTs, an acceptable strategy (for the French CRC screening programme) would be 2-day sampling with at least one positive test at a cut-off between 150-200 ng/mL (OC-Sensor) and 176-234 ng/mL (FOB-Gold).

Liquid biopsy in colorectal cancer

Garcia-Foncillas J. et al. (2018) British Journal of Cancer:
Prospective multicenter real-world RAS mutation comparison between OncoBEAM-based liquid biopsy and tissue analysis in metastatic colorectal cancer
What we see as the essence:
This study represents the first prospective RAS mutation performance comparison providing a final concordance of 92% between plasma and tissue samples using the OncoBEAM™ RAS CRC assay (236 mCRC patients). This outcome reveals that the plasma-based OncoBEAM™ RAS CRC assay is a reliable opportunity to detect RAS mutations in order to decide about the rationale of applying anti-EGFR therapy.
Garcia J. et al. (2018) Oncotarget:
Cross-platform comparison for the detection of RAS mutations in cfDNA (ddPCR Biorad detection assay, BEAMing assay, and NGS strategy)
What we see as the essence:
This study compared the performance of the OncoBEAM™ RAS CRC IVD assay to ddPCR and NGS for the detection of KRAS/NRAS mutations in plasma from mCRC and NSCLC patients based of the analysis of paired blood and tissue samples. The OncoBEAM™ RAS CRC test revealed higher sensitivity than the two other technologies by testing cfDNA vs tissue analysis in mCRC and NSCLC samples (extended RAS panel) and enabled monitoring of somatic alterations in plasma-derived cfDNA.
Klein-Scory S. et al. (2018) Translational Oncology:
Significance of Liquid Biopsy for Monitoring and Therapy Decision of Colorectal Cancer
What we see as the essence:
This study monitored three mCRC patients who initially were RAS WT and demonstrate that follow-up using OncoBEAM RAS testing in plasma provides information about the clonal redistribution after discontinuation of anti-EGFR as well as emerging RAS mutations leading to resistance during anti-EGFR administration. On top of this it has been observed that RAS mutations can even develop in the absence of anti-EGFR therapy pressure.
Garcia-Foncillas J. et al. (2017) Annals of Oncology:
Incorporating BEAMing technology as a liquid biopsy into clinical practice for the management of colorectal cancer patients: an expert taskforce review
What we see as the essence:
BEAMing technology for the detection of mutated ctDNA in plasma based on international guideline-recommended expanded RAS testing offers the opportunity of rapid turnaround times, high sensitivity and standardization compared to conventional testing of tissue samples. The high degree of concordance between plasma OncoBEAM RAS testing versus standard tissue testing methods has been shown in several studies. BEAMing posseses the potential to replace tissue biopsy for the detection and monitoring of RAS mutations and enables precision and cost-effective CRC patient management by individualizing treatment plans.
Grasselli J. et al. (2017) Annals of Oncology:
Concordance of blood- and tumor-based detection of RAS mutations to guide anti-EGFR therapy in mCRC
What we see as the essence:
“Tumor tissue from 146 mCRC patients was tested for RAS status with standard of care (SoC) PCR techniques, and Digital PCR (BEAMing) was used both in plasma and tumor tissue. Plasma RAS determination showed high overall agreement and captured a mCRC population responsive to anti-EGFR therapy with the same predictive level as SoC tissue testing. The feasibility and practicality of ctDNA analysis may translate into an alternative tool for anti-EGFR treatment selection.”
Vidal J. et al. (2017) Annals of Oncology:
Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients
What we see as the essence:
RAS in tissue and plasma samples from 115 mCRC patients showed a 93% overall agreement using the OncoBEAM™ RAS CRC assay. Monitoring of RAS ctDNA in patients RAS wt showed that OncoBEAM was useful to detect RAS mutations during anti-EGFR treatment. It was finally concluded that the high overall agreement in RAS mutational assessment between plasma and tissue supports blood-based testing with OncoBEAM™ as a viable alternative for genotyping RAS of mCRC patients and that it is useful to monitor RAS in patients undergoing systemic therapy to detect potential treatment resistances.
Toledo R.A. et al. (2017) Oncotarget:
Clinical validation of prospective liquid biopsy monitoring in patients with wild-type RAS metastatic colorectal cancer treated with FOLFIRI-cetuximab
What we see as the essence:
”The current study provides evidences, obtained for the first time in an unbiased and prospective manner, that reinforces the utility of LqB for monitoring mCRC patients.”
Jones F.S. et al. (2016) ASCO:
Performance of Standardized BEAMing Platform for Detecting RAS Mutations in the Blood of Metastatic Colorectal Cancer (mCRC) Patients
What we see as the essence:
“The high overall agreement of plasma and tissue RAS testing results (93.3%) demonstrates that blood-based OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based RAS testing. Plasma RAS testing also provides an opportunity to monitor tumor RAS mutation dynamics during therapy in patients with systemic disease.”
Saunders M.P. et al. (2016) ESMO:
Performance assessment of blood based RAS mutation testing: concordance of results obtained from prospectively collected samples
What we see as the essence:
“The high overall agreement of plasma and tissue RAS testing results (92.2%) shows that OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based testing in this prospective study. Analysis of discordants shows that differences between plasma and tissue RAS results may arise from tumour heterogeneity, disease evolution, low ctDNA shedding, or low tumour burden.”
Schmiegel W. et al. (2016) Molecular Oncology:
Blood-based detection of RAS mutations to guide anti-EGFR therapy in colorectal cancer patients: Concordance of results from circulating tumor DNA and tissue-based RAS testing
What we see as the essence:
”The high concordance of plasma and tissue results demonstrates that blood-based RAS mutation testing is a viable alternative to tissue-based RAS testing.”
Siravegna G. et al. (2015) Nature Medicine:
Clonal Evolution and Resistance to EGFR Blockade in the Blood of Colorectal Cancer Patients
What we see as the essence:
Liquid instead of tissue biopsy can be used to closely monitor the dynamic molecular evolution of metastatic colorectal tumors during anti-EGFR therapy in order to identify those patients that benefit from anti-EGFR.
Morelli M.P. et al. (2015) Annals of Oncology:
Characterizing the patterns of clonal selection in circulating tumor DNA from patients with colorectal cancer refractory to anti-EGFR treatment
What we see as the essence:
”Monitoring treatment-induced genetic alterations by sequencing ctDNA could identify biomarkers for treatment screening in anti-EGFR-refractory patients.”
Tabernero J. et al. (2015) The Lancet Oncology:
Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial
What we see as the essence:
BEAMing of circulating tumour DNA allowed the non-invasive analysis of tumour genotype in real time and the detection of tumour-associated mutations.
Misale S. et al. (2014) Science Translational Medicine:
Blockade of EGFR and MEK Intercepts Heterogeneous Mechanisms of Acquired Resistance to Anti-EGFR Therapies in Colorectal Cancer
What we see as the essence:
Liquid biopsies used for monitoring RAS mutations of mCRC patients on anti-EGFR therapy enable early initiation of combination therapies with MEK inhibitors in order to optimize the therapy success and delay disease progression.
Misale S. et al. (2012) Nature:
Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
What we see as the essence:
“…our results suggest that blood-based non-invasive monitoring of patients undergoing treatment with anti-EGFR therapies for the emergence of KRAS mutant clones could allow for the early initiation of combination therapies that may delay or prevent disease progression.”
Diehl F. et al. (2008) Nature Medicine:
Circulating mutant DNA to assess tumor dynamics
What we see as the essence:
“We found that ctDNA measurements could be used to reliably monitor tumor dynamics in subjects with cancer who were undergoing surgery or chemotherapy. We suggest that this personalized genetic approach could be generally applied to individuals with other types of cancer.”

Lymph node analysis in colorectal cancer

Marhic A. et al. (2017) Digestive and Liver Disease:
Molecular analysis of sentinel lymph node in colon carcinomas by one-step nucleic acid amplification (OSNA) reduces time to adjuvant chemotherapy interval
What we see as the essence:
Intraoperative analysis of SLNs by OSNA significantly reduces the time to adjuvant chemotherapy after surgery.
Yeung T.M. et al. (2017) Surgical Endoscopy:
Intraoperative identification and analysis of lymph nodes at laparoscopic colorectal cancer surgery using fluorescence imaging combined with rapid OSNA pathological assessment
What we see as the essence:
“OSNA can be combined with NIR and ICG lymphatic mapping to provide intraoperative assessment of nodal tissue in patients with colorectal cancer.”
Rakislova N. et al. (2017) Journal of Translational Medicine:
Lymph node pooling: a feasible and efficient method of lymph node molecular staging in colorectal carcinoma
What we see as the essence:
“LN pooling makes it possible to analyze a high number of LNs from surgical colectomies with few molecular tests per patient. This approach enables a feasible means to integrate LN molecular analysis from CC specimens into pathology diagnosis and provides a more accurate LN pathological staging with potential prognostic implications.”
Aldecoa I. et al. (2016) Virchows Archiv:
Molecularly determined total tumour load in lymph nodes of stage I-II colon cancer patients correlates with high-risk factors. A multicentre prospective study
What we see as the essence:
OSNA allows the identification of tumour burden (undetected by hystology) in lymph nodes of early colon cancer patients. Moreover, the Total Tumour Load (TTL) determined by OSNA correlates with high-risk factors and may be used for a better selection of stage I–II patients at risk of recurrence.
Aldecoa I. et al. (2016) Surgical Endoscopy:
Endoscopic tattooing of early colon carcinoma enhances detection of lymph nodes most prone to harbor tumor burden
What we see as the essence:
Endoscopic tattooing clearly improves identification of lymph nodes. Moreover, this method allows the detection of those lymph nodes most prone to carry tumor burden as demonstrated by the Total Tumour Load (TTL) values.
Yamamoto H. et al. (2016) Annals of Surgical Oncology:
OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan
What we see as the essence:
High concordance between OSNA and histology. Besides, the TTL values determined by OSNA show to increase as the number of metastatic lymph node increases showing a trend compatible to the current pathological diagnosis system.
Vogelaar FJ. et al. (2014) Annals of Surgical Oncology:
The diagnostic value of one-step nucleic acid amplification (OSNA) for sentinel lymph nodes in colon cancer patients
What we see as the essence:
The OSNA method shows a performance comparable to multilevel fine pathological examination. Since it enables whole lymph node analysis, sampling bias can be avoided leading to a more accurate tumour staging.
Croner RS. et al. (2014) British Journal of Cancer:
Molecular staging of lymph node-negative colon carcinomas by one-step nucleic acid amplification (OSNA) results in upstaging of a quarter of patients in a prospective, European, multicentre study
What we see as the essence:
More than 25% of initially pN0 patients were upstaged by OSNA suggesting that this standardized and accurate method may improve staging.
Yamamoto N. et al. (2013) Japanese Journal of Clinical Oncology:
An optimal mRNA marker for OSNA (One-step nucleic acid amplification) based lymph node metastasis detection in colorectal cancer patients
What we see as the essence:
A CK19 mRNA copy number cut-off of 75-500 copies/µl leads to a high sensitivity and specificity of the OSNA method.
Güller U. et al. (2012) Cancer:
Molecular investigation of lymph nodes in colon cancer patients using one-step nucleic acid amplification (OSNA): a new road to better staging?
What we see as the essence:
The OSNA method shows comparable performance such as intensive histopathological evaluation and may lead to upstaging of more than 15% of colon cancer patients.
Yamamoto H. et al. (2011) Annals of Surgical Oncology:
OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan
What we see as the essence:
OSNA can be considered a novel molecular examination tool for the staging of colon cancer patients.
Croner RS. et al. (2010) Journal of Translational Medicine:
One step nucleic acid amplification (OSNA) - a new method for lymph node staging in colorectal carcinomas
What we see as the essence:
The OSNA method allows the rapid analysis of the whole node and can applied as tool to determine nodal status in colon cancer patients.

Lymph node localisation in colorectal cancer

Pouw et al. (2016) Colorectal Disease:
Ex vivo sentinel lymph node mapping in colorectal cancer using a magnetic nanoparticle tracer to improve staging accuracy: a pilot study
What we see as the essence:
Based on 28 ex-vivo specimens of colorectal cancer, the authors concluded that ex vivo magnetic sentinel lymph node mapping with the Sentimag®/Sienna+® System is a feasible technique, which improves nodal staging accuracy.
(2010) IFMBE Proceedings:
ten Haken et al. Magnetic Detection of the Sentinel Lymph Node in Ex Vivo Tissue with Colorectal Cancer
What we see as the essence:
The experimental approach on ex-vivo specimen indicated that SLN detection with Sentimag® is possible in colon cancer.

Magnetic impalpable lesion localisation

Harvey et al. (2017) ABS Conference:
Magseed – Safety and feasibility study of the use of magnetic marker seeds to localise breast cancers
What we see as the essence:
Based on an initial experience in 29 breast cancer patients. All seed were detected and recovered without challenges. The author concluded, that Magseed is a safe and feasible device that offers accurate localisation and logistic enhancements.

Sentinel lymph node analysis in breast cancer

Fung V. et al. (2017) Molecular and Clinical Oncology:
Intraoperative prediction of the two axillary lymph node macrometastases threshold in patients with breast cancer using a one-step nucleic acid cytokeratin-19 amplification assay
What we see as the essence:
“OSNA identifies a TTL threshold value where, in the presence of involved SLNs, ALND may be avoided. This technique offers objective confidence in adopting conservative management of the axilla in patients with SLN macrometastases.”
Peg V. et al. (2017) The Breast:
Role of total tumour load of sentinel lymph node on survival in early breast cancer patients
What we see as the essence:
“SLN TTL permits the differentiation between two patient groups in terms of DFS and OS, independently of axillary staging (pN), age and tumour characteristics (size, grade, lymphovascular invasion). This new data confirms the clinical value of low axillary involvement and could partially replace the information that staging of the entire axilla provides in patients on whom no axillary lymph node dissection is performed.”
Terrenato I. et al. (2017) PLoS One:
A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients
What we see as the essence:
“Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.”
Di Filippo F et al. (2016) Journal of Experimental & Clinical Cancer Research:
Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
What we see as the essence:
”The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.”
Parada D. et al. (2016) Molecular and Clinical Oncology:
Intraoperative molecular analysis of sentinel lymph nodes following neoadjuvant chemotherapy in patients with clinical node negative breast cancer: An institutional study
What we see as the essence:
“The OSNA assay is a highly sensitive, specific and reproducible diagnostic technique that can be used to analyse SLNs following NAC. The total tumoral load may assist with predicting additional non SLN metastases.”
Espinosa-Bravo M. et al. (2016) The Breast:
Intraoperative assessment of sentinel lymph node by one-step nucleic acid amplification in breast cancer patients after neoadjuvant treatment reduces the need for a second surgery for axillary lymph node dissection
What we see as the essence:
The accurate and standardized intraoperative SLN analysis by OSNA decreases the need of a second surgery in 18.5% of breast cancer patients with a positive SLN after neoadjuvant therapy.
Shimazu K. et al. (2016) Surgery Today:
Clinical significance of breast cancer micrometastasis in the sentinel lymph node
What we see as the essence:
The OSNA method shows the benefit of reproducibility among different institutions and the capability of analysing a whole lymph node in only 30-40 minutes.
Kubota M et al. (2016) Molecular and Clinical Oncology:
One-step nucleic acid amplification assay for intraoperative prediction of advanced axillary lymph node metastases in breast cancer patients with sentinel lymph node metastasis
What we see as the essence:
The Total Tumour Load (TTL) determined by OSNA analysis can predict further axillary lymph node metastases in breast cancer patients. The TTL can be assessed intra-operatively, thus it can be used during surgery to determine the need for axillary lymph node dissection.
Banerjee SM et al. (2016) European Journal of Surgical Oncology:
The use of one-step nucleic acid amplification (OSNA) and tumour related factors in the treatment of axillary breast cancer: A predictive model
What we see as the essence:
A predictive model combining Total Tumour Load (TTL) determined by OSNA analysis with lymphovascular invasion can identify breast cancer patients who require additional axillary treatment, i.e. axillary lymph node dissection or other adjuvant measures.
Vieites B. et al. (2016) Histopathology:
CK19 expression in breast tumours and lymph node metastasis after neoadjuvant therapy
What we see as the essence:
The expression of CK19 protein is preserved after neoadjuvant therapy. This indicates that OSNA is a suited approach for lymph node analysis also upon neoadjuvant treatment.
Bernet L. et al. (2015) Revista de Senología y Patología Mamaria:
A multiparametric predictive model of axillary status in patients with breast cancer: total tumoral load and molecular signature. A multicenter study
What we see as the essence:
“The inclusion of PM in the multivariate model improved the AUC, especially when the total number of sentinel nodes were included. Differences were observed in the impact of the CTT among the different molecular profiles subtypes.”
Di Filippo F. et al. (2015) Journal of Experimental & Clinical Cancer Research:
Elaboration of a nomogram to predict non sentinel node status in breast cancer patients with positive sentinel node, intra-operatively assessed with one step nucleic acid amplification method
What we see as the essence:
The nomogram described by Di Filippo et al. is a very useful tool for predicting non-SLN status in breast cancer patients with positive SLNs assessed intra-operatively by OSNA.
Piñero-Madrona A. et al. (2014) The Breast:
Tumoral load quantification of positive sentinel lymph nodes in breast cancer to predict more than two involved nodes
What we see as the essence:
In this study, the OSNA result clearly correlates with the risk of having two or more metastatic non-SLNs in breast cancer patients.
Rubio IT. et al. (2014) Breast Cancer Research and Treatment:
Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients
What we see as the essence:
The nomogram described by Rubio et al. incorporates the Total Tumour Load (TTL) assessed by OSNA and can be used to predict non-SLN positivity. This useful tool can support clinicians in decision-making.
Deambrogio C. et al. (2014) Journal of Clinical Pathology:
A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies eligible for axillary lymph node dissection in breast cancer
What we see as the essence:
The CK19 mRNA copy number represents a useful tool to predict the probability of nodal involvement and thus, it can be applied for the selection of patients in which axillary lymph node dissection could be recommended due to the high risk of further axillary lymph node metastases.
Klingler S. et al. (2013) Annals of Oncology:
Using one-step nucleic acid amplification (OSNA) for intraoperative detection of lymph node metastasis in breast cancer patients avoids second surgery and accelerates initiation of adjuvant therapy
What we see as the essence:
The intraoperative SLN analysis by OSNA reduces the need of a second surgery in breast cancer patients and allows a prompt initiation of adjuvant therapy.
Espinosa-Bravo M. et al. (2013) European Journal of Surgical Oncology:
Prediction of non-sentinel lymph node metastasis in early breast cancer by assessing total tumoral load in the sentinel lymph node by molecular assay
What we see as the essence:
Intraoperatively assessed Total Tumour load (TTL) in SLNs of clinically node negative breast cancer patients predicts for further non-SLN metastasis. TTL helps decision-making on performing or not axillary lymph node dissection.
Osako T. et al. (2013) European Journal of Cancer:
Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: molecular whole-node analysis of all removed nodes
What we see as the essence:
The CK19 mRNA copy number determined by OSNA predicts non-SLN metastases. This study further support the predictive value of the OSNA result.
Osako T et al. (2013) British Journal of Cancer:
Molecular detection of lymph node metastasis in breast cancer patients treated with preoperative systemic chemotherapy: a prospective multicentre trial using the one-step nucleic acid amplification assay
What we see as the essence:
“The OSNA assay can detect the residual tumour burden as accurately as conventional pathology, although chemotherapy-induced histological changes are present.”
Navarro-Cecilia J. et al. (2013) European Journal of Surgical Oncology:
Intraoperative sentinel node biopsy by one-step nucleic acid amplification (OSNA) avoids axillary lymphadenectomy in women with breast cancer treated with neoadjuvant chemotherapy
What we see as the essence:
The OSNA result can predict the axillary status with a high accuracy also in clinically node negative patients at initial presentation who underwent neoadjuvant therapy.
Peg V. et al. (2013) Breast Cancer Research and Treatment:
Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients
What we see as the essence:
The Total Tumour Load (TTL) determined by OSNA is an independent predictor of the nodal status and can support clinicians in personalising surgical treatment.
Sagara Y. et al. (2013) Journal of Breast Cancer:
Clinical application of the one-step nucleic acid amplification method to detect sentinel lymph node metastasis in breast cancer
What we see as the essence:
The OSNA assay allows the accurate analysis of SLN and the prediction of non-SLN metastases. Moreover, applying this technique reduces pathologist’s workload.
Helimann T. et al. (2013) Journal of Cancer Research and Clinical Oncology:
Intra-operative use of one-step nucleic acid amplification (OSNA) for detection of the tumor load of sentinel lymph nodes in breast cancer patients
What we see as the essence:
OSNA is a very useful tool for supporting intra-operative decision-making about further axillary surgery, thus reducing the risk of second surgeries. Moreover, the CK19 copy number allows the prediction of further lymph node involvement and might help to find adequate adjuvant treatment options.
Ohi Y. et al. (2012) British Journal of Cancer:
Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer
What we see as the essence:
The CK19 mRNA copy number in the SLN is the most significant predictor of non-SLN involvement.
Le Frère-Belda MA. et al. (2012) International Journal of Cancer:
Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients
What we see as the essence:
The OSNA method shows a higher sensitivity than intraoperative histological evaluation, and thus its use possibly leads to a decrease of the number of women who require a second surgical procedure for axillary lymph node dissection.
Cserni G. (2012) Journal of Clinical Pathology:
Intraoperative analysis of sentinel lymph nodes in breast cancer by one-step nucleic acid amplification
What we see as the essence:
Cserni et al. describes in this review current literature and concerns related to the OSNA method.
Castellano I. et al. (2012) Annals of Surgery:
Reliability of whole sentinel lymph node analysis by one-step nucleic acid amplification for intraoperative diagnosis of breast cancer metastases
What we see as the essence:
Whole SLN analysis by OSNA provides objective and reproducible results that help treatment decision making and accurate characterisation of SLN staging.
Godey F. et al. (2012) Journal of Breast Cancer Research and Treatment:
Sentinel lymph node analysis in breast cancer: contribution of one-step nucleic acid amplification (OSNA)
What we see as the essence:
The intraoperative analysis of SLN by OSNA enables the surgeon to perform, when necessary, axillary lymph node dissection during the same procedure.
Bernet L. et al. (2011) Histopathology:
Diagnosis of the sentinel lymph node in breast cancer: a reproducible molecular method: a multicentric Spanish study
What we see as the essence:
OSNA is a very sensitive, specific and reproducible method that enables standardisation of the SLN diagnostic procedure.
Snook KL. et al. (2011) British Journal of Surgery:
Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma
What we see as the essence:
OSNA allows accurate intraoperative evaluation of SLN and show excellent concordance with histology. This promising approach will become the standard method for analysis of SLN and axillary LNs.
Schem C. et al. (2009) Virchows Archiv:
One-step nucleic acid amplification – a molecular method for the detection of lymph node metastases in breast cancer patients; results of the German study group
What we see as the essence:
OSNA is a reliable and standardized tool for the intraoperative detection of lymph node metastases and its adoption may lead to a benefit for the patients since unnecessary second surgeries are avoided.
Visser M. et al. (2008) International Journal of Cancer:
Intra-operative rapid diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer
What we see as the essence:
OSNA enables whole lymph node analysis and therefore, sampling errors, which are related to histological techniques, are avoided. Moreover, the automated procedure leads to a high degree of standardization and objectivity.
Tsujimoto M. et al. (2007) Clinical Cancer Research:
One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients
What we see as the essence:
CK19 mRNA copy number cut-off values enable to distinguish among macrometastasis, micrometastasis, and non-metastasis. The clinical findings indicate that the OSNA assay is a useful intraoperative detection method for the detection of lymph node metastasis in breast cancer patients.

Sentinel lymph node localisation in prostate cancer

Winter et al. (accepted) European Urology:
Magnetic Resonance Imaging of Sentinel Lymph Nodes Using Intraprostatic Injection of Superparamagnetic Iron Oxide Nanoparticles in Prostate Cancer Patients: First-in-human Results.
What we see as the essence:
The study in 50 patients with prostate cancer provided high sensitivity results in sentinel lypmph node biopsy with the Sentimag®/Sienna+® System and can be performed by an urologist alone.
Winter et al. (2017) Current Opinion in Urology:
Sentinel lymph node surgery in prostate cancer using magnetic particles
What we see as the essence:
In this review it was concluded that SPION-MRI, combined with a hand-held magnetometer (Sentimag), provides a nonradioactive technique for preoperative and intraoperative SLN localization. Compared with ePLND, sPLND provides increased diagnostic value and supports the individualized extension of PLND using sPLND in prostate cancer.
Winter et al. (2017) Molecules:
Magnetic Marking and Intraoperative Detection of Primary Draining Lymph Nodes in High-Risk Prostate Cancer Using Superparamagnetic Iron Oxide Nanoparticles: Additional Diagnostic Value?
What we see as the essence:
By using the Sentimag®/Sienna+® System in 104 patients with prostate cancer, the authors demonstrate the high sensitivity and additional diagnostic value of magnetometer-guided sentinel lymph node biopsy, exceeding that of ePLND.
Stanik et al. (2017) European Urology Supplements:
Sentinel lymph node dissection in prostate cancer using superparamagnetic particles of iron oxide: Early clinical experience.
What we see as the essence:
Based on 20 patients with prostate cancer, the authors state, that the Sentimag®/Sienna+® method provides results comparable to radiotracer with the avoidance of radioactivity and preoperative imaging.
Winter et al. (2014) Annals of Surgical Oncology:
A novel method for intraoperative sentinel lymph node detection in prostate cancer patients using superparamagnetic iron oxide nanoparticles and a handheld magnetometer: the initial clinical experience.
What we see as the essence:
First data of 20 patients with prostate cancer indicate that the sentinel lymph node biopsy with Sentimag®/Sienna+® is a simple, radiation-free, safe, feasible, and reliable method.

sentinel lymph node localisation in breast cancer

Karakatsanis et al. (2017) British Journal of Surgery:
Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer
What we see as the essence:
This study in 338 breast cancer patients showed that the use of SPIO is easy and can be performed by the surgeon alone. Detection rates in Sentinel Lymph Node Biopsy are comparable to the dual technique.
Karakatsanis A. et al. (2016) Breast Cancer Research and Treatment:
The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc99 and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies
What we see as the essence:
“SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics.”
Teshome M. et al. (2016) Annals of Surgical Oncology:
Use of a Magnetic Tracer for Sentinel Lymph Node Detection in Early-Stage Breast Cancer Patients: A Meta-analysis
What we see as the essence:
Sentinel Lymph node detection with Sienna+® revealed non-inferior performance to the standard method in breast cancer patients with clinically node-negative status.
Houpeau J.L. et al. (2015) Journal of Surgical Oncology:
Sentinel lymph node identification using superparamagnetic iron oxide particles versus radioisotope: The French Sentimag feasibility trial
What we see as the essence:
Sentinel lymph node detection with Sienna+ is seen as a feasible method and a promising alternative to radiotracer. A beneficial potential was identified for ambulatory surgery or sites without nuclear medicine departments.
Ghilli M. et al. (2015) European Journal of Cancer Care:
The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment
What we see as the essence:
Sentimag® was identified as safe with non-inferior performance compared to the radiotracer. The Sentimag® technique can be applied after a minimum learning curve. Especially when nuclear medicine units are not available, the magnetic detection provides an effective treatment of breast cancer patients.
Piñero-Madrona et al. (2015) European Journal of Surgical Oncology:
The superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study
What we see as the essence:
This study showed non-inferiority of the Sentimag technique compared to radiotracer. Ex-vivo and intraoperative detection rates at the node level were found to be slightly higher with Sentimag.
Rubio I.T. et al. (2014) European Journal of Surgical Oncology:
The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer
What we see as the essence:
Detection of SLNs with SPIO was not inferior to radiotracer. Procedure is safe, reliable and facilitates patients and OR management.
Thill M. et al. (2014) The Breast:
The Central-European SentiMag study Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope
What we see as the essence:
“We obtained convincing results that magnetic SLNB can be performed easily, safely and equivalently well in comparison to the radiotracer method.”
Douek M. et al. (2013) Annals of Surgical Oncology:
Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial
What we see as the essence:
Sentimag/Sienna+ is a feasible technique for SLNB. The identification rate is not inferior to the standard.
Platelets

General PLT

Ortiz A et al. (2020) Sysmex J Int; 30(1): 9:
Performance Comparison of Sysmex Hematology Analyzers XN-550 and XN-10.
What we see as the essence:
The XN-550 is highly reliable with functionality comparable to the XN-10. It has shown high correlation coefficients and excellent comparative performance in all CBC, DIFF and RET parameters (except BASO%). The overall flagging comparison was excellent among the XN-10, the XN-550 and the manual differential.
Arbiol-Roca A et al. (2018) EJIFCC; 29(1): 48:
Reference intervals for a complete blood count on an automated haematology analyser Sysmex XN in healthy adults from the southern metropolitan area of Barcelona.
What we see as the essence:
The aim of the study was to establish reference intervals for CBC, DIFF and reticulocytes for a Spanish population. Significant gender differences were found for RBC, PLT, HCT and HGB.
Cao J et al. (2017):
Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.
Lab Med; 48(2): 188
What we see as the essence:
The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims.
Cornet E et al. (2016) Scand J Clin Lab Invest; 76(6): 465:
Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC).
What we see as the essence:
Using the biomedical validation criteria, 21.3 % of samples triggered
a smear review. Modification of four criteria reduced the number of smears from 21.3 % to 15.0 % without loss of clinical value.
Van Dievoet MA et al. (2016) Int J Lab Hematol; 38(5): 490:
Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.
What we see as the essence:
The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser.
SEO JY et al. (2015):
Performance evaluation of the new hematology analyzer Sysmex XN-series.
Int J Lab Hematol; 37(2): 155
What we see as the essence:
A good correlation was found between the XN-Series and XE-series for all parameters. The XN-Series dramatically reduced the smear rate (by 58%). Even at counts below 500/µL the XN provided an accurate WBC count using the Low WBC mode.
Arneth B et al. (2015):
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
J Clin Lab Anal; 29(3): 175
What we see as the essence:
This paper gives a good overview of the technology behind the XE-series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers.
Genevieve F et al. (2014):
Smear microscopy revision: propositions by the GFHC.
feuillets de Biologie; VOL LVI N° 317
What we see as the essence:
The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.

IPF

Jeon MJ et al. (2020) Korean J Intern Med; 35(4): 970:
Immature platelet fraction based diagnostic predictive scoring model for immune thrombocytopenia
What we see as the essence:
The authors concluded that immature platelet fraction (IPF) could be a useful parameter to distinguish immune thrombocytopenia (ITP) from other causes of thrombocytopenia. They developed the predictive scoring model that could predict ITP with high probability.
Jeon K et al. (2020) Medicine (Baltimore); 99(7): e19096:
Immature platelet fraction: A useful marker for identifying the cause of thrombocytopenia and predicting platelet recovery
What we see as the essence:
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover IPF is a robust and reliable predictor of platelet recovery in patients with immune thrombocytopenia (ITP) and with malignancies undergoing chemotherapy.
El-Gamal RA et al. (2020) Indian J Hematol Blood Transfus; 36(2): 316:
Combined Immature Platelet Fraction and Schistocyte Count to Differentiate Pregnancy-Associated Thrombotic Thrombocytopenic Purpura from Severe Preeclampsia/Haemolysis, Elevated Liver Enzymes, and Low Platelet Syndrome (SPE/HELLP)
What we see as the essence:
IPF and manual schistocyte counts were able to discriminate pregnancy-associated severe preeclampsia/haemolysis, elevated liver enzymes, and low platelet syndrome (SPE/HELLP) versus thrombotic thrombocytopenic purpura (TTP) patients. The model based on combination of parameters had a good predictive value to discriminate TTP from SPE/HELLP - sensitivity of 92.3%, specificity of 62.5% and AUC 0.827.
Buttarello M et al. (2020) Int J Lab Hematol; online ahead of print:
Reticulated platelets and immature platelet fraction: Clinical applications and method limitations
What we see as the essence:
Thorough review about reticulated platelets and immature platelet fraction including overview of preanalytical and analytical limitations of methods and clinical applications.
van De Wyngaert Z et al. (2019) Curr Res Transl Med; 68(1):37:
Immature platelet fraction (IPF): A reliable tool to predict peripheral thrombocytopenia.
What we see as the essence:
This retrospective study found that IPF higher than 13 % is predictive of peripheral thrombocytopenia. In isolated thrombocytopenia bone marrow aspiration could have been avoided in 66 % of patients in this study cohort.
Johnson S et al. (2019):
A CBC algorithm combined with immature platelet fraction is able to identify JAK2 V617F mutation-positive polycythaemia vera patients.
Int J Lab Hematol; 41(2): 271
What we see as the essence:
The study proposes an algorithm based on CBC and IPF# parameters that allows to identify a cohort of high-likelihood polycythaemia vera (PV) patients and refer them for haematological review. IPF# > 20 ×109/L in combination with positive CBC criteria can identify JAK2 V617F mutation-positive PV patients.
Bernstein U et al. (2019) Arch Gynecol Obstet; 299(6): 1537:
The immature platelet fraction in hypertensive disease during pregnancy
What we see as the essence:
This study shows that IPF% can be used to identify hypertensive diseases in pregnancy. Moreover, the absolute number of IPF and platelets could help to differentiate preeclampsia and HELLP syndrome.
Tantanate C et al. (2019) Scand J Clin Lab Invest; 79(3):160:
Analytical performance of automated platelet counts and impact on platelet transfusion guidance in patients with acute leukemia.
What we see as the essence:
In this study the performance of impedance platelet counting using PLT-I, LH-750 (PLT-LH), as well as PLT-F was analysed in patients with acute leukaemia. PLT-F demonstrated an excellent performance for the identification of thrombocytopenia and had the lowest rate of undertransfusion. Additionally, the authors found that a high blast count is associated with inaccurate PLT-LH and PLT-I counts.
Perl L et al. (2019) Platelets; 17:1:
Prognostic significance of reticulated platelet levels in diabetic patients with stable coronary artery disease.
What we see as the essence:
In stable coronary artery disease patients with diabetes the increased levels of immature platelets (IPF) are associated with a higher risk of major adverse cardiovascular events and inversely correlated with the risk of bleeding.
Thorup C et al. (2019) Semin Thromb Hemost; 46(3): 320:
Immature Platelets As a Predictor of Disease Severity and Mortality in Sepsis and Septic Shock - A Systematic Review
What we see as the essence:
Based on nine studies the review highlighted that an increased number of immature platelets is associated with increase disease severity and mortality in patients with sepsis and septic shock.
Hannawi B et al. (2018) Thromb Haemost; 118(9): 1517:
Reticulated Platelets - Changing Focus from Basics to Outcomes.
What we see as the essence:
The authors discussed the role of reticulated platelets in coronary artery disease and in hypo responsiveness to the commonly used anti-platelet drugs. Reticulated platelets may be a useful marker for predicting worse cardiovascular outcome.
Buoro S et al. (2018) J Clin Pathol.; 71(4): 330:
Innovative haematological parameters for early diagnosis of sepsis in adult patients admitted in intensive care unit.
What we see as the essence:
The combination of an increased value of IPF# and a decreased value of RET% 24 hours before the onset of sepsis in ICU patients may be considered an early, rapid, inexpensive and widely available measure of sepsis prediction.
Sakuragi M et al. (2018) Int J Hematol; 107(3): 320:
Immature platelet fraction (IPF) as a predictive value for thrombopoietic recovery after allogeneic stem cell transplantation.
What we see as the essence:
IPF was able to predict platelet recovery in patients after allogeneic haematopoietic stem cell transplantation in 5 out of 11 patients, while IPF# was able to predict recovery in 7 out of 11 patients. Cut-offs of 5.8 % and 200/µL were used, respectively.
Pedersen OH et al. (2017) Am J Case Rep; 18: 945:
Recurrent Cardiovascular Events Despite Antiplatelet Therapy in a Patient with Polycythemia Vera and Accelerated Platelet Turnover.
What we see as the essence:
The case report illustrates that insufficient platelet inhibition with clopidogrel monotherapy in a patient with thrombocytosis may be associated with recurrent arterial thrombosis. A plausible explanation may be an accelerated platelet turnover reflected by an increased number of immature platelets.
Anetsberger A et al. (2017) Thromb Haemost; 117(10): 1887:
Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery.
What we see as the essence:
IPF with optimal cut-off of > 5.4 % is an independent predictor of major adverse cardiovascular events, deep vein thrombosis or pulmonary embolism (modMACE) after non-cardiac surgery and improve risk stratification of surgical patients.
Ferreira FLB et al. (2017) Sci Rep; 7(1): 3355:
Evaluation of the immature platelet fraction contribute to the differential diagnosis of hereditary, immune and other acquired thrombocytopenias.
What we see as the essence:
The authors evaluated the use of IPF in the differential diagnosis between ITP and hereditary macrothrombocytopenia (HM). The IPF values were higher in HM than in ITP as already demonstrated by other studies.
Freynhofer MK et al. (2017) Thromb Haemost; 117(5): 923:
Platelet turnover predicts outcome after coronary intervention.
What we see as the essence:
An elevated platelet turnover independently predicts major adverse cardiovascular events after percutaneous coronary intervention. The optimal cut-off value was at IPF = 3.35 %.
MacQueen BC et al. (2017) J Perinatol; 37(7): 834:
The immature platelet fraction: creating neonatal reference intervals and using these to categorize neonatal thrombocytopenias.
What we see as the essence:
Neonatal reference intervals for IPF and IPF# were reported according to gestational age, and during the first 90 days after birth. Moreover, neonates with hyporegenerative thrombocytopenias had lower IPF and IPF# than neonates with consumptive ones.
Buoro S et al. (2017) Scand J Clin Lab Invest; 77(1): 73:
Abnormal leukocyte scattergrams and immature platelet fraction on Sysmex XN-9000 analyzer: a new diagnostic tool for altered megakaryopoiesis?
What we see as the essence:
This case report shows how a high IPF, combined with abnormal WNR, WDF and WPC scattergrams could be used as a marker of dysmegakaryopoiesis, and led to the diagnosis of MDS type 2-refractory anaemia with excess blasts (REAB-2) in a nine year-old girl.
Jaing TH et al. (2016):
Assessment of platelet activation and immature platelet fraction as predictors of platelet engraftment after hematopoietic stem cell transplantation.
Cell Transplant; 25: 1259
What we see as the essence:
The study showed that IPF (XE-2100) can be used to assess thrombopoietic recovery after stem cell transplantation. Patients in the cord blood group had a higher IPF than the peripheral blood group on day 56 and day 97 post-transplantation.
Cremer M et al. (2016) Seminars in Fetal & Neonatal Medicine; 21(1): 10:
Thrombocytopenia and platelet transfusion in the neonate.
What we see as the essence:
The review summarises the pathophysiology and current management (including platelet transfusion thresholds) of neonatal thrombocytopenia. Novel index score for bleeding risk in thrombocytopenic neonates is proposed (including IPF#).
Moraes D et al. (2016) Platelets; 27(4): 333:
Immature platelet fraction in hypertensive pregnancy.
What we see as the essence:
IPF% measured on the XE-5000 in pregnant women suffering hypertensive disorders was higher than in control group (3.8, 2.4–5.1 %; 8.6, 5.8–10.6 %; 7.3, 4.2–10.2 %; p < 0.001 for control group, preeclampsia syndrome and non-proteinuric hypertension, resp.).
Hong H et al. (2015) Transfusion; 55(4): 756:
Absolute immature platelet count dynamics in diagnosing and monitoring the clinical course of thrombotic thrombocytopenic purpura.
What we see as the essence:
The absolute IPF (from XE-5000) is useful to diagnose and to monitor the clinical course of therapeutic plasma exchange in TTP patients. Routine analysis of the absolute IPF is recommended for diagnosis and to better assess the need for adjustment of treatment.
Sakuragi M et al. (2015) Int J Hematol; 101(4): 369:
Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders.
What we see as the essence:
IPF% from the XN-1000 and RP% obtained by immuno flow cytometry had a comparable diagnostic value for the distinction between controls, immune thrombocytopenia (due to platelet destruction) and aplastic thrombocytopenia.
Mao W et al. (2015) Clin Res Hepatol Gastroenterol; 39(4): 469:
Immature platelet fraction values predict recovery of platelet counts following liver transplantation.
What we see as the essence:
IPF% value predict recovery of PLT counts after liver transplantation. PLT counts reached the pre-transplant levels at 3-4 days after the IPF% peak value.
Miyazaki K et al. (2015) Hematology; 20(10): 587:
Immature platelet fraction measurement is influenced by platelet size and is a useful parameter for discrimination of macrothrombocytopenia.
What we see as the essence:
The IPF% values were about five times higher in May-Hegglin disorders (IPF 48.6 ± 1.9 %) and about twice as high in other macrothrombocytopenias (IPF 18.4 ± 2.1 %) than in ITP patients with similar platelet counts (IPF 9.2 ± 0.3 %).
Adly AA et al. (2015) Platelets; 26(7): 645:
Evaluation of the immature platelet fraction in the diagnosis and prognosis of childhood immune thrombocytopenia.
What we see as the essence:
IPF% obtained from the XE-2100 was increased in immune thrombo-cytopenia patients but not in patients with haematological malignancies. Therefore, IPF% may be used to evaluate the thrombopoietic state of the bone marrow.
Morkis IVC et al. (2015) Int J Lab Hematol; 37(2): 259:
Assessment of immature platelet fraction and immature reticulocyte fraction as predictors of engraftment after hematopoietic stem cell transplantation.
What we see as the essence:
Both IRF% and IPF% can be used to predict neutrophil and platelet recovery, respectively. Work was done on XE-5000.
Greene LA et al. (2015) Br J Haematol; 166(4): 592:
Beyond the platelet count: immature platelet fraction and thromboelastometry correlate with bleeding in patients with immune thrombocytopenia.
What we see as the essence:
The IPF# demonstrated stronger correlation with acute bleeding score than platelet counts. The strongest correlation was seen for paediatric patients with platelet counts <30 x109/L. High IPF# was associated with low bleeding score.
Ko Y et al. (2015) Clin Chem Lab Med; 53(7): 1091:
Reference interval for immature platelet fraction on Sysmex XN hematology analyzer: a comparison study with Sysmex XE-2100.
What we see as the essence:
Reference intervals for PLT, IPF% and IPF# were established on the XE- and XN-Series. It was found that the values measured on the XN were higher than on the XE-2100.
Ibrahim H et al. (2014) J Am Coll Cardiol; 64: 2122:
Association of Immature Platelets With Adverse Cardiovascular Outcomes.
What we see as the essence:
IPF# (XE-2100) allows for stratification of patients with coronary artery disease in terms of risk for future adverse events. Patients with an IPF# level ≥ 7,632 /µL were more likely to experience an adverse event (hazard odds ratio: 4.65; p < 0.002).
Dadu T et al. (2014) Int J Lab Hematol; 36(5): 499:
Evaluation of the IPF as an indicator of PLT recovery in dengue patients.
What we see as the essence:
IPF can be used to monitor the thrombocytopenia in patients with dengue fever. Furthermore, it can predict the recovery of PLT and so avoid unnecessary blood transfusions.
Everett TR et al. (2014) Thromb Haemost; 111(6): 1177:
Immature platelet fraction analysis demonstrates a difference in thrombopoiesis between normotensive and preeclamptic pregnancies.
What we see as the essence:
The study illustrates the potential utility of IPF as a parameter to distinguish between normotensive and preeclamptic pregnant women. The authors suggest that IPF is a far better parameter than MPV, which has previously been suggested for this purpose, and can distinguish between the two groups even at normal platelet counts.
Van der Linden N et al. (2014):
Immature platelet fraction (IPF) measured on the Sysmex XN haemocytometer predicts thrombopoietic recovery after autologous stem cell transplantation.
Eur J Haematol; 93(2): 150
What we see as the essence:
"IPF is a promising predictor of platelet recovery in patients after autologous SCT." "The proposed cut-off value of 5.3% can theoretically be used to decide whether or not to give a platelet transfusion."
Bat T et al. (2013) Transfusion; 53(6): 1201:
Measurement of the absolute immature platelet number reflects marrow production and is not impacted by platelet transfusion.
What we see as the essence:
Absolute IPF is a good parameter to assess the megakaryocytic activity of the bone marrow in transfusion-dependent thrombocytopenic patients.
Cremer M et al. (2013):
Low immature platelet fraction suggests decreased megakaryopoiesis in neonates with sepsis or necrotizing enterocolitis.
J Perinatol; 33(8): 622
What we see as the essence:
Low absolute IPF values during the course of neonatal sepsis/necrotising enterocolitis suggest suppression of megakaryopoietic activity.
Ko Y et al. (2013) Int J Lab Hematol; 35(5): 528:
Establishment of reference interval for immature platelet fraction.
What we see as the essence:
The study provides reference intervals for PLT, IPF% and absolute IPF from more than 2,000 healthy individuals and from umbilical cord blood, according to the CLSI guideline. These results could be used as fundamental data for clinical use as well as future researches.
Cesari F et al. (2013) Thrombosis and Haemostasis; 109: 846:
Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study.
What we see as the essence:
Reticulated (immature) platelets may be independent predictors of cardiovascular death and may potentially be useful in improving risk stratification for acute coronary syndrome patients.
Sinclair L (2012) Aust J Med Sci; 33(1): 10:
The immature platelet fraction: where is it now?
What we see as the essence:
A clear and concise review of 53 original publications concerning the clinical value of IPF. The diagnostic and prognostic potential of IPF in various conditions, and also advantages and limitations of IPF are described.
Sinclair L (2012) Aust J Med Sci; 33(2): 48:
The immature platelet fraction: an assessment of its application to a routine clinical laboratory.
What we see as the essence:
The purpose of the review is to assess the suitability of the IPF%
as a routine test. Productivity rather than clinical value is discussed. Reference ranges are given.
Psaila B et al. (2012) Blood; 119: 4066:
In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation.
What we see as the essence:
IPF% was higher in patients with ITP than the controls, reflecting the increased platelet production. Treatment with eltrombopag led to increased platelet counts, platelet size, and absolute IPF, but no significant change in IPF%.
Parco S et al. (2012) OncoTargets and Therapy; 5: 1:
Application of reticulated platelets to transfusion management during autologous stem cell transplantation.
What we see as the essence:
Using IPF-rich platelet transfusions reduces the number of transfusions and bleedings after stem cell transplantation in paediatric patients.
Zucker ML et al. (2012) Int J Lab Hematol; 34: 525:
Mechanism of thrombocytopenia in chronic hepatitis C as evaluated by the immature platelet fraction.
What we see as the essence:
IPF% can support the differentiation between platelet destruction and bone marrow failure in hepatitis C patients.
Goncalo A et al. (2011) Transplant Proc; 43: 241:
Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients.
What we see as the essence:
The immaturity fractions IPF and IRF offer an easy and early evaluation method of post-transplantational recovery of the bone marrow
Barsam SJ et al. (2011) Blood 117; 5723:
Platelet production and platelet destruction: assessing mechanisms of treatment effect in immune thrombocytopenia.
What we see as the essence:
The absolute immature platelet count (IPF#) can be used to assess the effect of different treatments of immune thrombocytopenia and could in such cases be more useful than IPF%.
Strauss G et al. (2010) Pediatr Blood Cancer; 57(4): 641:
Immature Platelet Count: A Simple Parameter for Distinguishing Thrombocytopenia in pediatric acute lymphocytic leukemia from immune thrombocytopenia.
What we see as the essence:
"Both IPF% and IPF# parameters should become a standard for evaluating the respective pathophysiology’s underlying both congenital and acquired thrombocytopenias."
Cesari F et al. (2010) Thrombosis and Haemostasis; 104: 804:
High platelet turnover and reactivity in renal transplant recipients patients.
What we see as the essence:
Renal transplant recipients showed significantly higher values of reticulated platelets (IPF) than healthy control subjects, especially in those not on aspirin treatment.
An elevated IPF% could be an additional hint for a mechanism involved in the increased cardiovascular risk profile of those patients.
Yamaoka G et al. (2010) Int J Lab Hematol; 32: e208:
The immature platelet fraction is a useful marker for predicting the timing of platelet recovery in patients with cancer after chemotherapy and hematopoietic stem cell transplantation.
What we see as the essence:
An IPF% of above 10% is a useful marker for predicting the timing of platelet recovery after chemotherapy and haematopoietic stem cell transplantation and has the potential to facilitate optimal platelet transfusion.
Cremer M et al. (2009) Br J Haematol 144: 619–621.:
Immature platelet fraction as novel laboratory parameter predicting the course of neonatal thrombocytopenia.
What we see as the essence:
"If the IPF is high, thrombocytopenic neonates are likely to recover on their own."
Hong KH et al. (2009) Blood Coag and Fibrinolysis; 20(6): 409:
Prognostic value of immature platelet fraction and plasma thrombopoietin in disseminated intravascular coagulation
What we see as the essence:
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover IPF is a robust and reliable predictor of platelet recovery in patients with immune thrombocytopenia (ITP) and with malignancies undergoing chemotherapy.
Takami A et al. (2007) Bone Marrow Transplant; 39: 501:
Immature platelet fraction for prediction of platelet engraftment after allogeneic stem cell transplantation.
What we see as the essence:
IPF counting can provide an accessible marker of engraftment after transplantation, especially of thrombopoietic activity.
Abe Y et al. (2006) Thromb Res; 118: 463:
A simple technique to determine thrombopoiesis level using immature platelet fraction (IPF).
What we see as the essence:
The results show that the IPF reflects the pathology of thrombo¬cytopenic disorders (i.e. consumptive versus productive). Measurement of the IPF is useful for the differential diagnosis and analysis of platelet kinetics and significantly more so than the mean platelet volume (MPV).
Briggs C et al. (2006) Transfus Med; 16: 101:
Immature platelet fraction measurement: a future guide to platelet transfusion requirement after haematopoietic stem cell transplantation.
What we see as the essence:
The automated IPF is a useful parameter in the clinical evaluation of the thrombocytopenic patient and has the potential to allow optimal transfusion of platelet concentrates.
Kickler T et al. (2006) Am J Clin Pathol; 125: 282:
A clinical evaluation of high fluorescent platelet fraction percentage in thrombocytopenia.
What we see as the essence:
The IPF (here named HFPF for ‘high fluorescence platelet fraction’) was predictive in the evaluation of thrombocytopenia. An elevated IPF is found with increased platelet production, particularly associated with platelet destruction, and in disorders associated with decreased platelet production the IPF is normal.
Briggs C et al. (2004) Br J Haematol; 126: 93:
Assessment of an immature platelet fraction (IPF) in peripheral thrombocytopenia.
What we see as the essence:
Automated IPF% measurement should become a standard parameter in evaluating the thrombocytopenic patient.

PLT-F

Tantanate C et al. (2017) Arch Pathol Lab Med; 141(6): 830:
Performance Evaluation of Automated Impedance and Optical Fluorescence Platelet Counts Compared With International Reference Method in Patients With Thalassemia.
What we see as the essence:
PLT-I, PLT-O and PLT-F in thalassaemia patients were compared with CD41/CD61 immune flow cytometry. PLT-O and PLT-F had better correlations with flow cytometry than PLT-I. PLT-F had a better specificity for detection of PTL counts below 100,000/µL.
Park SH et al. (2015) Ann Lab Med; 34(6): 471:
The Sysmex XN-2000 Hematology Autoanalyzer Provides a Highly Accurate Platelet Count than the Former Sysmex XE-2100 System Based on Comparison with the CD41/CD61 Immunoplatelet Reference Method of Flow Cytometry.
What we see as the essence:
PLT-F counts from the XN-Series were more accurate than PLT-O counts from the XE series when compared with the CD41/CD61 immunoplatelet reference method.
Wada A et al. (2015):
Accuracy of a New Platelet Count System (PLT-F) Depends on the Staining Property of Its Reagents. PLoS One; 10(10)
What we see as the essence:
The study showed that the PLT-F reagent labels intracellular structures within platelets and confirms previous findings that it strongly marks CD41/CD61-positive platelets.
Tailor H et al. (2014) Hospital Health Care Europe (HHE); 2:181:
Evaluating platelet counting on a new automated analyser.
What we see as the essence:
The PLT-F channel of the XN-Series shows excellent precision and accuracy even in abnormal samples or samples with fragmented red cells, large platelets and low PLT counts when compared to the reference flow cytometric method.
Tanaka Y et al. (2014) J Clin Lab Anal; 28(5): 341:
Performance Evaluation of Platelet Counting by Novel Fluorescent Dye Staining in the XN-Series Automated Hematology Analyzers.
What we see as the essence:
Compared to PLT-I and PLT-O counts, PLT-F had the best correlation with CD61-immunoplatelet counts. PLT-F counts were not affected by WBC fragments in two acute leukaemia patients or by RBC fragments and microcytes in a burn injury patient.
Schoorl M et al. (2013):
New fluorescent method (PLT-F) on Sysmex XN2000 hematology analyzer achieved higher accuracy
in low platelet counting.
Am J Clin Pathol;140: 495
What we see as the essence:
The PLT-F method of the XN-2000 demonstrated excellent reproducibility in samples with low platelet counts. Therefore, it is recommended for making decisions about platelet transfusions.
Briggs C et al. (2012) J Clin Pathol; 65:1024:
Performance evaluation of the Sysmex haematology XN modular system.
What we see as the essence:
The XN showed reduced sample turnaround time and reduced number of blood film reviews compared to the XE-2100 without loss of sensitivity and with more precise and accurate results for both platelets and low WBC counts.

PLT-O

Briggs C et al. (2004) Clin Lab Haematol; 26:157:
The most accurate platelet count on the Sysmex XE-2100. Optical or impedance?
What we see as the essence:
The accuracy of the XE-2100 platelet counting on chemotherapy samples with low counts is excellent when the switching algorithm is used. The optical count is not always the most accurate and the overriding of the algorithm is not good practice.
Red Blood Cells

ESR

Kratz A et al. (2017) Int J Lab Hematol; 39(5): 448:
ICSH recommendations for modified and alternate methods measuring the erythrocyte sedimentation rate
What we see as the essence:
The gold standard for the determination of the erythrocyte sedimentation rate is still the Westergren method. Alternative methods should be accepted when they have been appropriately validated and their results are expressed by comparison with the gold standard.
Schapkaitz E et al. (2017):
Evaluation of the InteRRliner automated erythrocyte sedimentation rate analyzer for a large academic laboratory. Int J Lab Hematol; 39(3):e66-e69.
What we see as the essence:
Indicated by the high correlation coefficient of 0.96 the InteRRliner showed an excellent comparability to the HumaSed ESR method.

FRC

Lesesve J et al. (2015) Int J Lab Hematol; 37(5): 583:
Fragmented red cells reference range for the Sysmex XN®-series of automated blood cell counters
What we see as the essence:
Normal values were determined on the XN-Series for the percentage fragmented red blood cells, FRC%: 0.14 +/- 0.35% (mean 0%). It was also found that HYPO-He correlates with FRC% so, samples with both a high HYPO-He and FRC% should be interpreted with care.
Hervent AS et al. (2015) Int J Lab Hematol; 37(5): 588:
This performance evaluation showed that the CELLAVISION Advanced RBC Software Application is easy to use and provides a sensitive and reproducible measurement of schistocytes in peripheral blood
What we see as the essence:
This performance evaluation showed that the CELLAVISION Advanced RBC Software Application is easy to use and provides a sensitive and reproducible measurement of schistocytes in peripheral blood.
Lesesve J-F et al. (2012) Int J Lab Hematol; 34(6): 566:
Fragmented red blood cells automated measurement is a useful parameter to exclude schistocytes on the blood film
What we see as the essence:
The automated FRC count offers a better degree of certainty than microscopy to exclude the presence of fragmented RBC.
Abe Y et al. (2009) Clin Appl Thromb Hemost; 15(3): 257:
The effectiveness of measuring for fragmented red cells using an automated hematology analyzer in patients with thrombotic microangiopathy.
What we see as the essence:
In conclusion, the FRC level is a simple and useful marker for thrombotic microangiopathy (TMA), and an FRC level of 1.2% is recommended as the cutoff value for the diagnosis of TMA.
Imoto S et al. (2005) Lab Hematol; 11(2): 131:
Usefulness of sequential automated analysis of fragmented red blood cells for the differential diagnosis of TTP-hemolytic uremic syndrome following allogeneic hematopoietic cell transplantation
What we see as the essence:
Sequential monitoring of FRC% may be a reliable marker for a specific type of complication (TTP-HUS; thrombotic thrombocytopenic pupura haemolytic uraemic syndrome) after allogeneic haematopoietic precursor cell transplantation.
Banno S et al. (2005) Clin Lab Haematol; 27(5): 292:
Quantification of red blood cell fragmentation by the automated hematology analyzer XE-2100 in patients with living donor liver transplantation
What we see as the essence:
The determination of FRC% by the XE-2100 enables early diagnoses and monitoring of TTP (thrombotic thrombocytopenic pupura) or TMA (thrombotic microangiopathy) and will be useful in the clinical field.

General RBC

Johnson S et al. (2019) Int J Lab Hematol; 41(2): 271:
A CBC algorithm combined with immature platelet fraction is able to identify JAK2 V617F mutation-positive polycythaemia vera patients.
What we see as the essence:
The study proposes an algorithm based on CBC and IPF# parameters that allows to identify a cohort of high-likelihood polycythaemia vera (PV) patients and refer them for haematological review. IPF# > 20 × 10e9/L in combination with positive CBC criteria can identify JAK2 V617F mutation-positive PV patients.
Yamatani K et al. (2019) Int J Lab Hematol; 41(6): e134:
Performance evaluation of the Sysmex DI‐60 overview application for tumor cell detection in body fluid samples
What we see as the essence:
The study aims to evaluate the Sysmex DI-60 instrument for the detection of malignant tumour cells in a range of different body fluid in comparison with manual microscopy and the XN-Series BF mode. In conclusion, the DI-60 overview analysis allows faster screening of malignant cells with accuracy comparable to manual microscopy.
Moioli V et al. (2019) Chem Lab Med; 57(12): e324:
Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
What we see as the essence:
Case study showing an abnormal WDF scattergram with a decrease of the fluorescence signal, causing the flag 'WBC Abn Scattergram'. In association with the microscopic revision and further genetic analysis an unstable haemoglobin (Hb Mozhaisk) was confirmed.
Jongbloed W et al. (2018) Clin Chem Lab Med; 56(9): e249:
Unstable haemoglobin variant Hb Leiden is detected on Sysmex XN-Series analysers
What we see as the essence:
Case study with an abnormal WDF scattergram observed on the XN-9000 causing the flag "WBC abnormal scattergram" which highlighted the inability to separate the white blood cell population. Further genetic analysis confirmed an unstable haemoglobin.
Arbiol-Roca A et al. (2018) EJIFCC; 29(1): 48:
Reference intervals for a complete blood count on an automated haematology analyser Sysmex XN in healthy adults from the southern metropolitan area of Barcelona.
What we see as the essence:
The aim of the study was to establish reference intervals for CBC, DIFF and reticulocytes for a Spanish population. Significant gender differences were found for RBC, PLT, HCT and HGB.
Huisjes R et al. (2018) Int J Lab Hematol; 40(2): 159:
Digital microscopy as a screening tool for the diagnosis of hereditary hemolytic anemia.
What we see as the essence:
Advanced RBC Morphology from CellaVision was used to characterise hereditary haemolytic anaemia. Cutoffs were reported for several RBC abnormalities and showed a high sensitivity and specificity for detection of different conditions.
Jo S et al. (2017) Int J Lab Hematol; 39(1): e4:
Performance evaluation of recently launched Sysmex XN-550 Automatic Hematology Analyzer
What we see as the essence:
The XN-550 showed a good analytical performance and strong correlation with XE-2100 and XN-3000 analysers for routine CBC parameters.
Teixeira C et al. (2017) Clin Chem Lab Med; 55(11): 243:
Automated detection of unstable hemoglobin variants by Sysmex XE-Series analyzers
What we see as the essence:
The authors tested 9 samples with known unstable HGB variants and reported that only the XE-2100 flagged the samples in contrast to the SIEMENS Healthineers ADVIA. This may help in diagnosing a congenital haemolytic anaemia.
Tailor H et al. (2017) Int J Lab Hematol; 39(6): 585:
Evaluation of the Sysmex XN-550, a Novel Compact Haematology analyser from the XN-L ® series, compared to the XN-20 system
What we see as the essence:
Samples from adult patients (N=202) were measured on the XN-550 and compared with an XN-20. Good correlations and low bias were observed for all parameters except for BASO%. PLT-O from the XN-550 showed no significant bias compared to PLT-F from the XN-20.
Tamigniau A et al. (2017) Ann Biol Clin (Paris); 75(3): 285:
From XE-2100 to XN-9000, from SIS Standard to GFHC recommendations for slide review: potential impact on review rate and turnaround time
What we see as the essence:
Changing from the XE-2100 to XN-9000 and implementing the Biomedical Validation ruleset led to a significant reduction in review rate (from 35.8% to 25.9%) and TAT. In this hospital this resulted in a cost reduction of 7000 Euros over 6 months.
Cao J et al. (2017) Lab Med; 48(2): 188:
Establishing a Stand-Alone Laboratory dedicated to the Care of Patients with Ebola Virus Disease.
What we see as the essence:
The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims.
Berda-Haddad Y et al. (2017) Int J Lab Hematol, 39(1): 32:
Increased mean corpuscular haemoglobin concentration: artefact or pathological condition?
What we see as the essence:
The use of the optical RBC parameters from the XN-Series can save time and help in the determination of the cause of increased MCHC.
Geara C et al. (2016) Int J Lab Hematol; 38(1): e10:
Comparative study of quantitative performances between the new Sysmex XN-L (XN-550) haematology analyser and the XN-9000 in a routine laboratory
What we see as the essence:
The XN-Series and XN-L Series were compared; correlations were good and the study showed that the XN-L Series provided the same high quality as the XN-Series.
Cornet E et al. (2016) Scand J Clin Lab Invest; 76(6): 465:
Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC)
What we see as the essence:
Using the biomedical validation criteria, 21.3% of samples triggered a smear review. Modification of four criteria reduced the number of smears from 21.3% to 15.0% without loss of clinical value.
Van Dievoet MA et al. (2016) Int J Lab Hematol; 38(5): 490:
Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.
What we see as the essence:
The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser.
Egele A et al. (2016) Int J Lab Hematol 38(5): e98:
Classification of several morphological red blood cell abnormalities by DM96 digital imaging.
What we see as the essence:
The authors report the cutoff values for most of the RBC abnormalities that can be detected by the Advanced RBC Morphology software.
Arneth B et al. (2015) J Clin Lab Anal; 29(3): 175:
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
What we see as the essence:
This paper gives a good overview of the technology behind the
XE-Series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers.
JO SY et al. (2015) Int J Lab Hematol:; 37(2): 155:
Performance evaluation of the new hematology analyzer Sysmex XN-series.
What we see as the essence:
A good correlation was found between the XN- and XE-Series for all parameters. The XN-Series dramatically reduced the smear rate (by 58%). Even at counts below 500/µL the XN provided an accurate WBC count using the Low WBC mode.
Egele A et al. (2015) Int J Lab Hematol 37(6): e153:
Automated detection and classification of teardrop cells by a novel RBC module using digital imaging/microscopy.
What we see as the essence:
The authors report excellent detection of teardrop cells in samples
from patients with myelofibrosis and MDS, using the Advanced RBC Morphology software.
Ferrero-Vacher C et al. (2015) Annales de Biologie Clinique; 73(6): 729:
Utilisation des paramètres érythrocytaires Sysmex dans un cas d’hémolyse sévère (Erythrocytic parameters Sysmex in a case of severe haemolysis)
What we see as the essence:
Case report of severe haemolytic anaemia with cold agglutinins, identified by increased MCHC and qualitative alarms. The RBC-O and HGB-O parameters from the RET channel, and the RBC most frequent volume (R-MFV) allowed to report the correct results.
Tabe Y et al. (2015) Clin Chem Lab Med; 53(2): 281:
Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system.
What we see as the essence:
This performance evaluation of the digital imaging analyser DI-60 showed a good agreement between results from the DI-60 and manual microscopy. In addition, blasts were correctly classified with 95% sensitivity and 99% specificity.
Genevieve F et al. (2014) feuillets de Biologie; VOL LVI N° 317:
Smear microscopy revision: propositions by the GFHC.
What we see as the essence:
The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.
Hotton J et al. (2013) Am J Clin Pathol 140: 845:
Performance and Abnormal Cell Flagging Comparisons of Three Automated Blood Cell Counters -: Cell-Dyn Sapphire, DxH-800, and XN-2000.
What we see as the essence:
Repeatability, linearity and carryover was good for all tested analysers, and correlation between the analysers was good for HGB, MCV, PLT and WBC.
Quotes: Quotes: "The XN showed a higher sensitivity than the SAPH and DxH for all flags of interest." "For the first time, we have decreased the slide review for our laboratory from 20% with the SAPH to 9.3% with the XN."
Wang H et al. (2013) Clin Lab.; 59: 217:
Use of RBC-O and S-MCV Parameters of Sysmex XE-2100 in a Patient with RBC Cold Agglutination
What we see as the essence:
A combination of sample dilution and the use of RBC parameters
from the RET channel on the XE-2100 is described to obtain accurate RBC parameters from samples with RBC cold agglutination without heating of the sample.
Mazumdar R et al. (2013) Leuk Res; 37(6): 614:
The automated monocyte count is independently predictive of overall survival from diagnosis in chronic lymphocytic leukaemia and of survival following first-line chemotherapy.
What we see as the essence:
A monocyte count >0.91 × 10^9/L at the time of diagnosis was associated with a shortened overall and treatment-free survival in CLL patients.
Godon A et al. (2012) Ann Biol Clin 2012; 70(2): 155:
Anomalies et erreurs de détermination de l’hémogramme avec les automates d’hématologie cellulaire Partie 3. Hémoglobine, hématies, indices érythrocytaires, réticulocytes.
What we see as the essence:
A summary report about potential interferences of CBC parameters with focus on situations leading to abnormal HGB, RBC and MCV, resulting in abnormal calculated RBC indices, e.g. MCHC. Alternative strategies may support management of interferences.

HYPO-He / HYPER-He / MicroR / MacroR

Schoorl M et al. (2012) Am J Clin Pathol 138: 300–304.:
Efficacy of Advanced Discriminating Algorithms for Screening on Iron-Deficiency Anemia and ß-Thalassemia Trait.
What we see as the essence:
The authors conclude that the advanced algorithms, derived from extended RBC parameters provided by the Sysmex XE-5000 analyzer, are useful as laboratory devices for anaemia screening.
Persijn L et al. (2012) Ann Hematol 91: 301–302.:
Screening for hereditary spherocytosis in routine practice: evaluation of a diagnostic algorithm with focus on non-splenectomised patients.
What we see as the essence:
"The hereditary spherocytosis diagnostic tool by Mullier et al. is useful and works, but needs fine-tuning to the local patient population."
Urrechaga E et al. (2011) Am J Clin Pathol; 135(3): 374:
The role of automated measurement of RBC subpopulations in differential diagnosis of microcytic anemia and β-thalassemia screening
What we see as the essence:
Because of high sensitivity and specificity, the new index %MicroR-%HYPO-He was the most reliable index in the differential diagnosis of microcytic anaemias.
Mullier F et al. (2011) Ann Hematol 90: 759–768.:
Additional erythrocytic and reticulocytic parameters helpful for diagnosis of hereditary spherocytosis: results of a multicentre study.
What we see as the essence:
"Combining several RBC parameters allows to efficiently screen for hereditary spherocytosis even in mild cases."
Urrechaga E et al. (2011) Int J Lab Hematol; 33:(1): 30-36:
The role of automated measurement of RBC subpopulations in differential diagnosis of microcytic anemia and β-thalassemia screening.
What we see as the essence:
Because of high sensitivity and specificity, the new index %microcytic-%hypochromic was the most reliable index in the differential diagnosis of microcytic anemia.
Urrechaga E. et al. (2011) J Clin Lab Anal; 25(3): 223:
Erythrocyte and reticulocyte parameters in iron deficiency and thalassemia
What we see as the essence:
Beta-thalassaemia can be recognised through high RBC, small
MCV, high %MicroR and moderately increased IRF, whereas iron deficiency shows high RDW and %HYPO-He
Urrechaga E et al. (2009) Clin Chem Lab Med; 47:(11): 1411:
Potential utility of the new Sysmex XE 5000 red blood cell extended parameters in the study of disorders of iron metabolism
What we see as the essence:
The new parameters %HYPO-He /%HYPER-He and %MicroR/%MacroR appear to be sensitive for detecting small changes in the number of red cells with inadequate haemoglobinisation and volume in order to distinguish beta-thalassaemia from iron deficiency anaemia.

Malaria-infected RBC (MI-RBC)

Post A et al. (2019) BMC Medicine; 17(1): 103:
The XN-30 hematology analyzer for rapid sensitive detection of malaria: a diagnostic accuracy study
What we see as the essence:
The novel technology of the Sysmex XN-30 provides a robust, rapid, automated and objective platform for diagnosing and quantifying malaria. The XN-30 ensures the prompt initiation of the malaria treatment and the malaria anaemia together with the reliable treatment monitoring.
Post A et al. (2019):
The XN-30 hematology analyzer for rapid sensitive detection of malaria: a diagnostic accuracy study; BMC Medicine; 17(1):103; Free online
What we see as the essence:
The novel technology of the Sysmex XN-30 provides a robust, rapid, automated and objective platform for diagnosing and quantifying malaria. The XN-30 ensures the prompt initiation of the malaria treatment and the malaria anaemia together with the reliable treatment monitoring.
Dumas C et al. (2018) (2018) J Clin Pathol; 71(7): 594:
Automated Plasmodium detection by the Sysmex XN hematology analyzer
What we see as the essence:
The study describes abnormal WDF scattergrams on the XN-Series for samples from patients infected with malaria. Most WDF scattergrams were not affected by Plasmodium falciparum infections but about 50% of non-falciparum infections caused scattergram abnormalities.

NRBC

Morton SU et al. (2020) A Pediatr Neonatol; online ahead of print:
Association of nucleated red blood cell count with mortality among neonatal intensive care unit patients.
What we see as the essence:
Neonatal ICU patients with NRBC count >0 had a significantly higher risk of mortality, and time to mortality decreased with higher NRBC counts. The authors claim that NRBC counts may be useful in refining prognostic models for neonates.
Menk M et al. (2018) Ann Intensive Care; 8(1): 42:
Nucleated red blood cells as predictors of mortality in patients with acute respiratory distress syndrome (ARDS): an observational study
What we see as the essence:
The study results confirmed previous findings in critically ill patients suggesting that NRBC are equally predictive of mortality in acute respiratory distress syndrome (ARDS). NRBC-positive patients were found to require longer treatment with mechanical ventilation, extra-corporal gas exchange and had prolonged ICU stay when compared with NRBC-negative patients.
Monteiro Junior JG et al. (2015) PLoS One; 10(12): e0144259:
Nucleated Red Blood Cells as Predictors of All-Cause Mortality in Cardiac Intensive Care Unit Patients: A Prospective Cohort Study. PLoS One. 29;10(12):e0144259
What we see as the essence:
"The presence of NRBC (XE-2100) was associated with a higher ICU mortality (49.4% vs 21.7%, P<0.001) as well as in-hospital mortality (61.4% vs 33.3%, p = 0.001)."
Cremer M et al. (2015) Early Hum Dev.; 91(10): 559:
Nucleated red blood cells as marker for an increased risk of unfavorable outcome and mortality in very low birth weight infants.
What we see as the essence:
This study of 438 low birth weight infants indicates that an NRBC count obtained 24-120 h after birth can serve as a surrogate marker for later severe morbidity and mortality. The optimal cut-off value was 2x10^9/L with 83% sensitivity and 75% specifity.
Tantanate C et al. (2014) Int J Lab Hematol.; 37(3): 341:
Performance evaluation of the automated nucleated red blood cell enumeration on Sysmex XN analyser.
What we see as the essence:
NRBC counts from the XN-Series could replace manual counts: the precision of the XN-Series was superior and a small bias (manual counts slightly higher than NRBC counts from the XN-Series) was only observed for NRBC counts above 200/100 WBC.
Hotton J et al. (2013) Am J Clin Pathol; 140(6): 845:
Performance and Abnormal Cell Flagging Comparisons of Three Automated Blood Cell Counters -Cell-Dyn Sapphire, DxH-800, and XN-2000
What we see as the essence:
Repeatability, linearity and carryover was good for all tested analysers, and correlation between the analysers was good for HGB, MCV, PLT and WBC.
Quotes: "The XN showed a higher sensitivity than the SAPH and DxH for all flags of interest." "For the first time, we have decreased the slide review for our laboratory from 20% with the SAPH to 9.3% with the XN."
Parco S et al. (2013) J Blood Med; 4: 23:
Public banking of umbilical cord blood or storage in a private bank: testing social and ethical policy in northeastern Italy
What we see as the essence:
An excellent correlation was found between manual NRBC counts
and NRBC counts from the XE-2100 (r2 = 0.94) in umbilical cord blood. This number may be used to correct the WBC count and thereby guarantee an adequate WBC concentration for blood banking
of umbilical cord blood.
Pipitone S et al. (2012) Clin Chem Lab Med; 50:(10): 1857:
Evaluation of automated nucleated red blood cells counting on Sysmex XE-5000 and Siemens ADVIA 2120
What we see as the essence:
The results show excellent analytical performances for the XE-5000, with high accuracy and precision. In agreement with previous studies, the authors also showed that despite similar performance in terms of analytical imprecision, the overall correlation with microscopy is higher for XE-5000 than for ADVIA 2120, i.e., correlation coefficient 0.97 vs. 0.67 and AUC 0.97 vs. 0.73, respectively.
Gasparović V et al. (2012) Coll Antropol; 36:(3): 853:
Nucleated red blood cells count as first prognostic marker for adverse neonatal outcome in severe preeclamptic pregnancies
What we see as the essence:
An increased count of nucleated red blood cells in preterm newborns born from pregnancies with severe preeclampsia seems to be the first significant marker for detecting adverse neonatal outcome.
Danise P et al. (2011) Clin Chem Lab Med; 50:(2): 357:
Evaluation of nucleated red blood cells in the peripheral blood of hematological diseases
What we see as the essence:
NRBC are found in nearly all onco-haematological diseases at diagnosis and frequently during therapy. They are absent at remission.
Danise P et al. (2009) Clin Chem Lab Med; 47(12): 1539:
Nucleated red blood cells and soluble transferrin receptor in thalassemia syndromes: relationship with global and ineffective erythropoiesis.
What we see as the essence:
The NRBC count helps defining ineffective erythropoiesis in thalassaemia patients and supporting transfusion management.
Stachon A et al. (2007) Crit Care; 11(3): R62:
Nucleated red blood cells in the blood of medical intensive care patients indicate increased mortality risk: a prospective cohort study: a prospective cohort study
What we see as the essence:
The NRBC count is one indicator of mortality ─ persistence (observed in daily screenings) and high concentration are both indicators for poor prognosis.
Stachon A et al. (2006) Clin Chem Lab Med; 44(8): 955:
Poor prognosis indicated by nucleated red blood cells in peripheral blood is not associated with organ failure of the liver or kidney
What we see as the essence:
The NRBC count is one indicator of mortality independent of other factors such as kidney or liver failure.
Stachon A et al. (2006) Clin Chim Acta; 366(1-2): 329:
Daily monitoring of nucleated red blood cells in the blood of surgical intensive care patients.
What we see as the essence:
NRBC count is an early indicator of mortality – daily screening is recommended.
Wang F-S et al (2003) Clin Lab Haematol; 25(1): 17:
Development and clinical application of nucleated red blood cell counting and staging on the automated haematology analyser XE-2100.
What we see as the essence:
The NRBC count correlates well with flow cytometry.
Stachon A et al. (2002) J Lab Clin Med; 140(6): 407:
Nucleated red blood cells indicate high risk of in-hospital mortality
What we see as the essence:
NRBC are often an only transient observation, but they indicate a poor prognosis, whether transient or persistent.
Briggs C et al. (2000) Clin Lab Haematol; 22(6): 345:
New quantitative parameters on a recently introduced automated blood cell counter - the XE 2100
What we see as the essence:
The automated NRBC count was highly correlated with the manual reference count (r2=0.97) and thus eliminates the need for manual NRBC counts. The use of the 'optical' platelet count signicantly improves the reliability of low platelet counts. The instrument will always report the most accurate platelet count on all samples, whether impedance or `optical'.

RET / IRF

La Gioia A et al. (2018) J Clin Pathol; 71(8): 729:
Short preheating at 41°C leads to a red blood cells count comparable to that in RET channel of Sysmex analysers in samples showing cold agglutination
What we see as the essence:
Detailed evaluation of the RET channel in terms of resolving cold-agglutinins. It provides comparable results like traditional manual 37°C/2h pretreatment and can therefore be recommended to shorten TAT.
Tiwari A et al. (2018) Vox Sang. 2018; 113(7): 639:
Applying newer parameter Ret-He (reticulocyte haemoglobin equivalent) to assess latent iron deficiency (LID) in blood donors-study at a tertiary care hospital in India.
What we see as the essence:
RET-He can be used as a routine screening test to detect latent iron deficiency in blood donors. This could provide an opportunity to make appropriate and timely interventions like dietary changes or drug supplementation.
Morkis IVC et al. (2015) Int J Lab Hematol; 37(2): 259:
Assessment of immature platelet fraction and immature reticulocyte fraction as predictors of engraftment after hematopoietic stem cell transplantation.
What we see as the essence:
Both IRF% and IPF% can be used to predict neutrophil and platelet recovery, respectively. Work was done on XE-5000.
Yesmin S et al. (2011) Bangladesh Med Res Council Bull 37(2): 57:
Immature reticulocyte fraction as a predictor of bone marrow recovery in children with acute lymphoblastic leukaemia on remission induction phase.
What we see as the essence:
In 52 % of paediatric ALL patients, IRF% values rose before NEUT# values during recovery after chemotherapy. Therefore, monitoring of both parameters may be beneficial.
Goncalo AP et al. (2011) Transplant Proc; 43: 24:
Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients.
What we see as the essence:
The immaturity fractions IRF and IPF offer an easy and early evaluation method of posttransplantational recovery of the bone marrow.

RET-He / RBC-He

Morton SU et al. (2020) Pediatr Qual Saf; 5(2): e258:
Screening With Reticulocyte HemoglobinIncreased Iron Sufficiency Among NICU Patients
What we see as the essence:
The authors found that implementation of an iron supplementation guideline utilizing RET-He values can improve iron sufficiency even for heterogeneous out-born neonatal intensive care unit patient populations. Normal RET-He range was defined as 27–38 pg based on published literature and expert consensus.
Chinudomwong P et al. (2020) J Clin Lab Anal; 34(6): e23225:
Diagnostic performance of reticulocyte hemoglobin equivalent in assessing the iron status
What we see as the essence:
RET-He (n = 953) was investigated in a variety of conditions, involving inflammation, and its diagnostic performance was evaluated in assessing the iron status. Iron deficiency anaemia (IDA) can be ruled out at a cut-off ≥30 pg. For RET-He <30 pg the study proposed a diagnostic algorithm to identify/distinguish between IDA and non-ID anaemia.
Tantawy AA et al. (2019) J Pediatr Hematol Oncol; 42(3): e147:
Reticulocyte Hemoglobin Content (Ret He): A Simple Tool for Evaluation of Iron Status in Childhood Cancer
What we see as the essence:
RET-He is considered an easy and affordable tool for assessment of iron deficiency anaemia (IDA) in children with cancer during chemotherapy. Due to the influence of underlying inflammatory conditions it is judged to be a more reaonable test than coventional iron parameters.
Levy S et al. (2018) Int J Lab Hematol; 40(6): 683:
The clinical utility of new reticulocyte and erythrocyte parameters on the Sysmex XN 9000 for iron deficiency in pregnant patients
What we see as the essence:
This study demonstrates the clinical efficacy of RET-He, %Hypo-He and %Micro-R for detecting ID in nonanemic pregnant patients. They are as well a cost effective alternative.
Jarc E et al. (2017) Zdrav Vestn (Slovenian Med J); 86(1-2): 19:
Comparison of erythrocyte and reticulocyte indices for the diagnosis of iron deficiency.
What we see as the essence:
Reticulocyte indices (Sysmex RET-He and Siemens CHr) are directly comparable. RET-He showed a slightly better predictive power for iron deficiency identification in IDA. Hypo-He (Sysmex) and %HYPO (Siemens) are not exchangeable, both can be used for long-term iron deficiency evaluation.
Wirawan R et al. (2017) Acta Med Indones; 49(1): 34:
Concordance between Reticulocyte Hemoglobin Equivalent and Reticulocyte Hemoglobin Content in CKD Patients Undergoing Hemodialysis.
What we see as the essence:
A very strong correlation (r=0.91) and a good concordance was found between RET-He and CHr with a mean bias of 0.5 pg in chronic kidney disease patients undergoing haemodialysis. It indicates that RET-He and CHr can both be used for assessing iron status.
Toki Y et al. (2017) Int J Hematol; 106(1): 116:
Evaluation of the hypochromic erythrocyte and reticulocyte hemoglobin content provided by the Sysmex XE-5000 analyzer in diagnosis of iron deficiency erythropoiesis.
What we see as the essence:
RET-He was shown to be a clinically useful marker for determining
iron deficiency in the general population and can also be used for the evaluation of the efficacy of iron administration.
Weimann A et al. (2016) (2016) Clin Lab; 62(4): 667:
Delta-He, Ret-He and a New Diagnostic Plot for Differential Diagnosis and Therapy Monitoring of Patients Suffering from Various Disease-Specific Types of Anemia
What we see as the essence:
A diagnostic plot using RET-He and Delta-He was developed based on differences between different patient groups suffering from anaemia. Several case examples show the clinical utility of this plot for therapy monitoring.
Buttarello M et al. (2016) Clin Chem Lab Med; 54(12): 1939:
Evaluation of the hypochromic erythrocyte and reticulocyte hemoglobin content provided by the Sysmex XE-5000 analyzer in diagnosis of iron deficiency erythropoiesis.
What we see as the essence:
RET-He and %Hypo- He, measured on the XE-5000, allowed identification of patients with iron deficiency, especially those who had already developed anaemia. RET-He had a better sensitivity, presumably because it is more responsive to iron deficiency.
Mehta S et al. (2016) J Assoc Physicians India; 64(11): 38:
Reticulocyte Hemoglobin vis-a-vis Serum Ferritin as a Marker of Bone Marrow Iron Store in Iron Deficiency Anemia.
What we see as the essence:
This study showed that RET-He is a better predictor of bone marrow iron stores in patients with severe anaemia than serum ferritin.
Urrechaga E et al. (2016) Int J Lab Hematol; 38(4): 360:
Percentage of hypochromic erythrocytes and reticulocyte hemoglobin equivalent predictors of response to intravenous iron in hemodialysis patients.
What we see as the essence:
HYPO-He and RET-He are reliable parameters for the study of erythropoiesis status in hemodyalisis patients.
Al-Ghananim RT et al. (2016) J Clin Lab Anal; 30(4): 326:
Reticulocyte Hemoglobin Content During the First Month of Life in Critically Ill Very Low Birth Weight Neonates Differs From Term Infants, Children, and Adults.
What we see as the essence:
RET-He values from the XE-2100 were lower in very low birth
weight infants than in term infants, children and adults. RET-He was 31.8 pg within 24 hr after birth and subsequently declined to a steady-state level of 28.4 pg.
Archer N et al. (2015) Crit Rev Clin Lab Sci.; 52(5): 256.:
Diagnosis of iron-deficient states.
What we see as the essence:
This review gives an overview of the haematological, biochemical
and genetic markers for identifying iron deficiency. RBC- He, RET-He, Delta- He, HYPO-He and MicroR are mentioned besides the standard RBC indices.
Peerschke E et al. (2014) Am J Clin Pathol; 142:(4): 506-512:
Using the Hemoglobin Content of Reticulocytes (RET-He) to Evaluate Anemia in Patients With Cancer.
What we see as the essence:
RET-He values above 31 or 32 pg could be used to rule out iron deficiency in cancer patients. In the present study the use of RET-He would have reduced the number of biochemical iron studies by 66% (from 209 to 70).
Urrechaga E et al. (2013) Int J Lab Hematol; 35:(2): 144:
Erythrocyte and reticulocyte indices in the assesment of erythropoiesis activity and iron availability.
What we see as the essence:
RET-He and %HYPO-He are helpful in assessing erythropoiesis and iron status.
Schoorl M et al. (2012) Hematology Reports; 4:(4): e24.:
Effects of iron supplementation on red blood cell hemoglobin content in pregnancy.
What we see as the essence:
RET-He and RET-He/RBC-He ratio are sensitive markers for screening when a decrease in red blood cell haemoglobin content is observed and for monitoring short-term effects of iron supplementation. The authors recommend integrating these parameters into the protocol for anaemia screening and monitoring during pregnancy.
Schoorl M et al. (2012) Int J Lab Hematol; 34(4): 390:
Temporary impairment of reticulocyte haemoglobin content in subjects with community-acquired pneumonia. Int J Lab Hematol 34: 390–395.
What we see as the essence:
In patients with community-acquired pneumonia, acute inflammation results in decreased RET-He values at an early stage, reflecting acute erythropoietic dysfunction.
Fernandez R et al. (2010) Anesthesiology 112(5): 1211:
Low Reticulocyte Hemoglobin Content Is Associated with a Higher Blood Transfusion Rate in Critically Ill Patients: A Cohort Study.
What we see as the essence:
The authors conclude that low reticulocyte haemoglobin content (RET-He) is common at admission at ICU in nonanaemic patients and it is associated with higher RBC transfusion requirements than in patients with normal RET-He values (39.1 % vs. 12.8 %, P = 0.02).
Maier-Redelsperger M et al. (2010) Blood Cell Mol Dis; 45:(4): 289:
Strong association between a new marker of hemolysis and glomerulopathy in sickle cell anemia.
What we see as the essence:
A special algorithm combining RBC-He, RET-He and lactate dehydrogenase bears the potential as a marker of haemolysis strongly correlated with albuminuria in sickle cell anaemia patients.
Jonckheere S et al. (2010) Acta Haematol ; 124:(1): 27:
Erythrocyte indices in the assessment of iron status in dialysis-dependent patients with end-stage renal disease on continuous erythropoietin receptor activator versus epoetin beta therapy
What we see as the essence:
Due to fluctuations of iron status parameters, a fixed time point should be used for iron status monitoring during erythropoietin therapy.
Leers MP et al. (2010) Int J Lab Hematol; 32(6 Pt 2): 572:
The value of the Thomas-plot in the diagnostic work up of anemic patients referred by general practitioners
What we see as the essence:
The Thomas-plot is helpful in diagnosing patients referred from general practitioners and differentiating functional iron deficiency from classical iron deficiency.
Schoorl M et al. (2010) Ned Tijdschr Klin Chem Labgeneesk; 35: 206 / Reprinted in Sysmex J Int; 20(1): 12:
Changes in red blood cell hemoglobinization during pregnancy.
What we see as the essence:
RET-He is a useful sensitive and early indicator of iron status in the second half of pregnancy and should ideally be measured in combination with zinc protoporphyrin (ZPP) and IRF.
Van Wyck DB et al. (2010) Am J Kidney Dis; 56:(3): 540:
Analytical and biological variation in measures of anemia and iron status in patients treated with maintenance hemodialysis. Am J Kidney Diseases 56: 540–546.
What we see as the essence:
RET-He could prove superior to transferrin saturation (TSAT) and ferritin in monitoring iron status of haemodialysis patients due to a lower biological variation.
Maconi M et al. (2009) Scand J Clin Lab Invest; 69(3): 365:
Erythrocyte and reticulocyte indices in iron deficiency in chronic kidney disease: comparison of two methods
What we see as the essence:
RET-He and CHr correlate and agree well in evaluating CKD patients needing iron support.
Miwa N et al. (2009) Int J Lab Hematol 32(2): 248:
Usefulness of measuring reticulocyte hemoglobin equivalent in the management of haemodialysis patients with iron deficiency
What we see as the essence:
RET-He is equivalent to CHr and useful in managing haemodialysis patients with iron deficiency as it responds more rapidly than HGB.
Mast A et al. (2008) Am J Hematol; 83:(4): 307:
Reticulocyte hemoglobin content.
What we see as the essence:
Reticulocyte haemoglobin can be used to differentiate iron deficiency from other causes of anaemia and as an early marker to monitor the therapy.
Thomas C et al. (2006) Med Oncol; 23:(1): 23:
The diagnostic plot: A concept for identifying different states of iron deficiency and monitoring the response to epoetin therapy.
What we see as the essence:
The Thomas-plot incl. RET-He can be used for the differential diagnosis of anaemia and also gives therapy options.
Brugnara C et al. (2006) Clin Lab Haematol; 28:(5): 303:
Reticulocyte hemoglobin equivalent (Ret He) and assessment of iron-deficient states
What we see as the essence:
RET-He is a reliable marker of cellular haemoglobin content and can be used to identify iron-deficient states, particularly in dialysis patients. RET-He and CHr are in good agreement.
Schoorl M et al. (2006) Clin Lab; 52:(11-12): 621:
Erythropoiesis activity, iron availability and reticulocyte hemoglobinization during treatment with hemodialysis and in subjects with uremia.
What we see as the essence:
Biochemical parameters reflecting functional iron availability and haematological parameters reflecting haemoglobinisation are interdependent.
Thomas L et al. (2005) Clin Chem Lab Med; 43(11): 1193:
Reticulocyte hemoglobin measurement -- comparison of two methods in the diagnosis of iron-restricted erythropoiesis
What we see as the essence:
RET-He can replace CHr in the diagnostic Thomas-plot without loss of sensitivity or specificity.
Canals C et al. (2005) Haematologica; 90(8): 1133:
Clinical utility of the new Sysmex XE 2100 parameter - reticulocyte hemoglobin equivalent - in the diagnosis of anemia.
What we see as the essence:
RET-He is useful for the differential diagnosis of iron deficiency anaemia vs anaemia of chronic disease and could also be helpful in the identification of thalassaemia patients.
Buttarello M et al. (2004) Am J Clin Pathol; 121:(4): 489:
The new reticulocyte parameter (RET-Y) of the Sysmex XE 2100: its use in the diagnosis and monitoring of posttreatment sideropenic anemia.
What we see as the essence:
RET-Y closely correlates with CHr and can be used for diagnosis and early monitoring after the administration of intravenous iron.
Urinalysis

Biochemistry

Oyaert M and Delanghe JR (2019) J Clin Lab Anal 33(5):e22870:
Semiquantitative, fully automated urine test strip analysis.
What we see as the essence:
This study evaluated the analytical and diagnostic performance of the UC-3500 for the presence of glucose, protein, albumin, leukocyte esterase, and hemoglobin peroxidase activity and ordinal scale results in comparison to the analysis of urine sediments using the UF-5000 as well as in comparison to wet clinical chemistry using the Roche cobas® 8000. Especially for detection of glycosuria, proteinuria and albuminuria, a perfect agreement between the reflectance data of the UC-3500 and immunochemistry results has been obtained. This allows the UC-3500 to provide a high‐throughput first‐level screening method for urinalysis which acts as a reliable sieving system to reduce the workload for further validation methods. Especially the albumin measurement fulfills optimum criteria for trueness allowing a reliable, semiquantitative detection of albumin.
Oyaert M et al. (2018) Clin Chem Lab Med 56(7):1126-1132:
Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase.
What we see as the essence:
This study investigates diagnostic accuracy of the Sysmex UC-3500 automated urine chemistry analyzer based that uses CMOS sensor technology for leukocyte esterase and hemoglobin peroxidase results. In addition, the influence of urinary dilution, haptoglobin, urinary pH and ascorbic acid on the test results has been assessed. In conclusion, CMOS technology allows to obtain high quality test strip results for assessing WBC and RBC in urine. Quantitative peroxidase and leukocyte esterase are complementary with flow cytometry and have an added value in urinalysis, which may form a basis for expert system development.
Delanghe JR et al. (2017) Clin Chim Acta 471:107-112:
Sensitive albuminuria analysis using dye-binding based test strips.
What we see as the essence:
Delanghe and colleagues investigated the potential of the CMOS sensor technology of the UC-3500 for obtaining quantitative albuminuria results in comparison to clinical wet chemistry using the cobas® 8000 immunochemistry analyser. For albumin, this study revealed a limit of detection of 5.5 mg/l, respecting limits for screening for albuminuria in patients at risk of CKD. A strong or good correlation between strip reflectance data and albuminuria creatinine, respectively, potentially allows quantification of albuminuria and ACR by dye-binding test strip.

Bladder Cancer

Ren C et al. (2020) Diagn Pathol 15(1):77:
Investigation of Atyp.C using UF-5000 flow cytometer in patients with a suspected diagnosis of urothelial carcinoma: a single-center study.
What we see as the essence:
This study evaluated the predictive power of the UF-5000 research parameter ‘Atypical Cells’ for patients with a suspected diagnosis of urothelial carcinoma. In total, urinary specimens of 128 patients that were enrolled for urinary cytology analysis were included in this investigation and analysed on the UF-5000, aiming to evaluate its performance in identifying atypical or malignant urothelial cells. The UF-5000 findings were in agreement with cytopathology in 73 % of the investigated cases. Using follow-up histologic diagnosis of urothelial carcinoma with or without urinary tract cytology (UTCy) as a reference standard the sensitivity and specificity were calculated with 59 % and 82.1 %, respectively. This resulted in a positive predictive value of 75.0% and a negative predictive value of 68.8%. In conclusion, the ‘Atypical Cells’ parameter bears the potential of an accessory test for urothelial carcinomas in context of routine urinary diagnostics, that might help to identify high-risk patients that require more specific follow-up and medical treatment.
Tınay İ et al. (2020) Bull Urooncol 19(1):17-19:
“Atypical Cell” Parameter in Automated Urine Analysis for the Diagnosis of Bladder Cancer: A Retrospective Pilot Study.
What we see as the essence:
This study evaluated the application of the UF-5000 and its research parameter ‘Atypical Cell’ in supporting the diagnosis of bladder cancer in a retrospective manner in a heterogenous study population. With an acceptable sensitivity of 75 % and a specificity of 100 %, the UF-5000 demonstrated potential value for diagnostic decisions on follow-up cystoscopy for patients with low-risk non-muscle invasive bladder cancer (NMIBC). For patients with high-risk NMIBC, sensitivity and specificity values are lower, but comparable or even better, if compared to cytology. The authors thus revealed the potential to avoid invasive procedures on patient side and to save costs for unnecessary treatments. To further investigate and validate the presented findings, a prospective study is in preparation.
Aydin O et al. (2020) Turk J Biochem; aop:
Atypical cells in Sysmex UN automated urine particle analyzer: a case report and pitfalls for future studies.
What we see as the essence:
The UF-4000 automatically detected atypical cells in the urine specimen of a 73-year old individual with recurrent high-grade urothelial carcinoma in an outpatient setting, which was confirmed by manual microscopy, demonstrating the potential of the UF-Series to detect malignancies.

Body fluid

Seghezzi M et al. (2017) Clin Chim Acta. 473:133-138:
Preliminary evaluation of UF-5000 Body Fluid Mode for automated cerebrospinal fluid cell counting.
What we see as the essence:
This study evaluated the body fluid mode of the UF-5000 for analysis of CSF in comparison to microscopy. The UF-5000 showed a high diagnostic accuracy for TNC, WBC and RBC counts, as well as high sensitivities and specificities and confirmed a low limit of detection for the RBCs. In conclusion, the UF-5000 body fluid mode offers rapid and accurate quantification of cells, including bacterial cells in CSF samples in clinically relevant concentration ranges, allowing the replacement of microscopy for CSF samples without abnormal cell counts or scattergrams.

General / Review

Oyaert M and Delanghe JR (2019) Ann Lab Med 39(2):15-22.:
Progress in Automated Urinalysis.
What we see as the essence:
This publication is a comprehensive review of the current status of automated urinalysis, highlighting the potential quantitative reading of urinary test strips using CMOS technology for albuminuria testing and the value of urinary flow cytometry for the differentiation of urinary microorganisms, screening for urinary tract infections and clinical decision support in a variety of nephrological and urological diseases. In addition, progress in automated urinary microscopy and the improved pathogen identification by MALDI-TOF mass spectrometry is reflected and an outlook into future technologies, such as laboratory-on-a-chip approaches, use of microfluids and mobile applications is given.

Medicoeconomics

Herráez Carrera Ó and Jarabon Bueno MDM (2020) Pharmacoecon Open 10(22) [Online ahead of print]:
Cost analysis of the automated examination of urine with the Sysmex UN-SeriesTM in a Spanish population.
What we see as the essence:
This study aimed to investigate the potential of the Sysmex UN-Series to reduce high financial costs and high and time-consuming laboratory workloads of current urinalysis practice. By investigating more than 90,000 handled urine samples of a 10-year period, including financial data and alternative costs of reference and test scenarios, potential average cost savings of 340,000 € per year was identified for the use of automated urine examination, compared to the current urinalysis practice. On top, the UN-Series has the potential to reduce the annual working hours of laboratory personnel to up to 1615 hours. In conclusion, the implementation of the UN-Series within routine practice in clinical laboratories could minimise costs, provide substantial savings for investment, improve laboratory procedures and could contribute to synergy between clinical analysis and microbiology laboratories.

Microbiology

Oyaert M et al. (2020) Clin Chem Lab Med 58(4):597-604:
Renal Tubular Epithelial Cells Add Value in the Diagnosis of Upper Urinary Tract Pathology.
What we see as the essence:
Oyaert and colleagues evaluated the analytical performance characteristics of renal tubular epithelial cells (RTECs) and transitional epithelial cells (TECs) on the Sysmex UF-5000 urine sediment analyser, as well as the diagnostic performance of these parameters to differentiate between lower and upper UTI. In comparison to transitional epithelial cells (TEC), increased urinary levels of renal tubular epithelial cells (RTEC) demonstrated a good potential to serve as a marker for the diagnosis of upper UTI and outperforms α1-micrglobulin in the discrimination between upper and lower UTI. However, the diagnostic performance of these parameters is strongly depending on proper sample handling.
Wagner K et al. (2019) J Glob Antimicrob Resist 19:8-13:
Evaluation of the AID AmpC line probe assay for molecular detection of AmpC Enterobacterales.
What we see as the essence:
This study investigated the use of commercially AID AmpC line probe assays for analysis of antibiotic resistance by detection of plasmid-mediated blaAmpC β-lactamase genes in Enterobacterales, which proofed to be an accurate, sensitive and easy-to-use test that can be readily implemented in any diagnostic laboratory. In this context, the UF-5000 has been demonstrated to be a reliable tool to judge samples, sent for molecular testing, for the presence of bacteriuria and to reduce the number of unnecessary molecular testing.
Öğüş E et al. (2019) ASMS 3(6):88-92:
Compatibility of the Results of an Automated Urine Analyzer with Urine Culture.
What we see as the essence:
This study evaluated the incidence of leukocyte esterase and nitrite positivity, leukocyte and bacterial counts in urine and Gram positive and negative bacterial results interpreted by the UF-5000 for compliance with urine culture results. Incorrect results for the Gram status in comparison to urine culture was obtained for three Gram-positive and three Gram-negative samples. Rates of leucocyte esterase, nitrite positivity, leukocyte and bacterial counts were higher in Gram negative group. In conclusion, especially Gram-negative bacterial interpretation obtained from the UF-5000 be beneficial for rapid typing of bacteria and early treatment in urinary tract infections.
De Rosa R et al. (2018) Clin Chim Acta 484:171-178:
Evaluation of the new Sysmex UF-5000 fluorescence flow cytometry analyser for ruling out bacterial urinary tract infection and for prediction of Gram-negative bacteria in urine cultures.
What we see as the essence:
De Rosa and colleagues investigated the potential of the UF-5000 to rule-out urinary tract infections and its ability to predict the presence of Gram-negative bacteria in urine samples with a request for urine culture in context of a suspected urinary tract infection. With neglectable carry-over and cross-contamination, the UF-5000 demonstrated a high screening performance for urinary tract infections with a high sensitivity and NPV for the bacteria using a cut-off of ≥58/μl. The ‘Gran Neg?’ flag predicted Gram negative urine cultures with good sensitivity and high specificity. In conclusion, the UF-5000 represents a reliable tool for ruling-out urinary tract infections with high diagnostic accuracy and offers the possibility to detect Gram-negative bacteria in very high agreement with urine culture. Further investigations might reveal the potential for the Gram information for targeted antibiotic.
Kim SY et al. (2018) J Clin Microbiol 56(8):e02004:
Rapid Screening of Urinary Tract Infection and Discrimination of Gram-Positive and Gram-Negative Bacteria by Automated Flow Cytometric Analysis Using Sysmex UF-5000.
What we see as the essence:
Kim and colleagues evaluated the performance of the UF-5000 in context of UTI screening, aiming to reduce unnecessary urine culture and improve the determination of antibiotic treatments. The performance to discriminate Gram-negative bacteria was superior to that for Gram-positive bacteria with high sensitivity and specificity in ≥105 CFU/ml monobacterial samples. In conclusion, the UF-5000 demonstrated a potential utility for the rapid screening of negative bacterial cultures, depending on the respective patient population, requiring cut-off optimization.
Duyeal Song et al. (2018) Ann Clin Microbiol 21(4):75-79:
Selection of Unnecessary Urine Culture Specimens Using Sysmex UF-5000 Urine Flow Cytometer.
What we see as the essence:
This study investigated the potential of the UF-5000 to support the reduction of unnecessary urine cultures by ruling-out bacterial and fungal urinary tract infections. Applying urinalysis cut-off values of 50/µl and 100/l for bacteria and YLC, respectively, 84 out of 126 requested urine cultures were negative and could have been ruled-out by the UF-5000. In conclusion, the bacteria and yeast-like cell counts delivered by the UF-5000 could be used to predict negative cultures and reduce the load of urine cultures by around 10% without sacrificing positive cultures.
Jurankova J et al. (2018) Poster on ECCMID 2018:
The importance of diagnosis gram-negative/gram positive bacteria in urine in the pre-culture screening of urine tract infections in the microbiology laboratory fluorescence flow cytometry on the UF-4000 urine analyser (Sysmex) for early initiation of targeted antibiotic therapy
What we see as the essence:
This study investigated sensitivity and specificity of the UF-4000 for the discrimination between Gram-positive and Gram-negative bacteria in pre-culture screenings for urinary tract infections in a microbiology laboratory using fluorescence flow cytometry. Gram-positive and Gram-negative bacteria have been detected in urine, with sensitivities 78 % and 89 % and specificities of 96 % and 89 %, respectively. In conclusion, UF-4000 demonstrated a high potential in pre-culture screenings of urinary infections in a microbiology laboratory and is of benefit to the patient for its role in early initiation of antibiotic therapy, targeting Gram-positive or Gram-negative bacteria.
Kawamura K et al. (2017) Jap J Med Technol 66(5):516-523 [Article in Japanese]:
Evaluation of automated urine particle analyzer, UF-5000, as a screening tool to identify Gram stainability of urinal pathogens.
What we see as the essence:
Kawamura and colleagues evaluated the performance of the UF-5000 with regards to the provision on information on the Gram status of bacterial cells via the BACT-info flag in comparison to conventional methods including Gram staining and quantitative bacterial culture. In summary, the UF-5000 presented in 83.2 % of UTI cases a Gram information, in line with classical Gram staining. The UF-5000 exhibited a high positive predictive value (93.3%) for both Gram negative staining and culture results. Thus, the UF-5000 using BACT-info shows great promise in screening for UTI pathogens and further improvements of judgement algorithms might make the Gram judgement even more reliable.
Geerts N et al. (2016) Clin Chim Acta 452:173–176:
Cut-off values to rule out urinary tract infection should be gender-specific.
What we see as the essence:
This study investigated the potential of urine flow cytometry of the UF-5000 to rule-out urinary tract infections and to reduce the load of urine culture samples. Applying cut-off value of >200 bacteria/μl, a sensitivity of 93.0%, a specificity of 63.5% and an NPV of 96.2% has been obtained. As a result, the culturing of 49% of all samples could be avoided. In addition, the data was retrospectively analyzed to determine if the introduction of gender-specific cut-off values could improve screening results. The obtained receiver operator curves are indeed significantly different when gender specific cut-offs were used. When an NPV of 95% is considered acceptable the unisex cut-off value of >200bacteria/μl can be used for women (NPV 94.9%), but the cut-off value for men could be raised to >400bacteria/μl without diminishing the NPV (NPV 95.0%).

Performance Evaluation / Comparison

Enko D et al. (2020) Clin Chem Lab Med 58(2):268-273 [Online version from 2019]:
Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy.
What we see as the essence:
Enko and colleagues demonstrate that the analytical performance of the UF-5000 is in strong concordance with manual phase-contrast microscopy and clearly outperforming the Roche cobas® u 701 module. This study included a broad spectrum of urine sediment pathologies, thereby proving the UF-5000 to be a reliable tool for automated urine sediment analysis in daily clinical practice.
Kucukgergin C et al. (2019) Scand J Clin Lab Invest. 79(7):468-474.:
Performance of automated urine analyzers using flow cytometric and digital image-based technology in routine urinalysis.
What we see as the essence:
This study evaluates the analytical performances of the UF-5000 and the Dirui FUS-200, to manual microscopy. Thereby, all available urinalysis aspects and sediment results were investigated within one hour after sample collection. Accurate results have been obtained from both analytical systems, the FUS-200 and the UF-5000, as good linearity without carry- over has been shown. Overall, the UF-5000 demonstrated better agreement in classification of WBCs, RBCs, ECs, positively affecting the morphologic recognition and enumeration of cells.
Cho J et al. (2019) Clin Chem Lab Med 57(11):1744-1753:
Comparison of five automated urine sediment analyzers with manual microscopy for accurate identification of urine sediment.
What we see as the essence:
This study evaluated the analytical and diagnostic performance of the Sysmex UF-5000, the Roche cobas® u 701 module, the URiSCAN PlusScope and the Iris iQ200SPRINT and the SIEMENS UAS800 in comparison to manual microscopy. Each automated urine sediment analyzer has certain distinct features, in addition to the common advantages of reducing the burden of manual processing. Therefore, laboratory physicians are encouraged to understand these features, and to utilize each system in appropriate ways, considering clinical algorithms and laboratory workflow.
Bakan E et al. (2018) Biochem Med (Zagreb) 28(2):020712:
Evaluation of the analytical performances of Cobas 6500 and Sysmex UN-Series automated urinalysis systems with manual microscopic particle counting.
What we see as the essence:
This study compared the diagnostic performance of the UF-5000 and the Roche cobas® u 701 module to manual microscopy. Comparing the quantification of WBCs and RBCs, the UF-5000 obtained the better sensitivities and specificities and showed high agreement with manual microscopy. In conclusion, the UF-5000 is a reliable tool for urine sediment analysis, but pathological samples should be confirmed by microscopy.
Previtali G et al. (2017) Clin Chim Acta 472:123-130:
Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber.
What we see as the essence:
Previtali and colleagues evaluated the analytical performance of the Sysmex UF-5000 for urine sediment samples compared manual particle counting using the Fuchs-Rosenthal chamber. The study demonstrated high linearity performances for RBCs, WBCs and epithelial cells, as well as high negative predictive values and good sensitivities and specificities for all parameters, especially those of clinical relevance. The authors conclude a high potential of the UF-5000 and its fluorescence flow cytometry technology to investigate urine sediment particles related to pathological conditions of the kidneys and the urinary tract.
White Blood Cells

Blood Bank mode

Mack S et al. (2020) Transfusion; 60(1): 4:
Component residual white blood cell counting made easy?
What we see as the essence:
A short review on required detection levels for blood products in US and Europe, and currently used methods on residual white blood cell counting. An outlook is given based on the publication by Blanco et al. how XN-Series analysers could increase the efficiency and reduce costs in blood banks in the future.
Blanco RA et al. (2020) Transfusion; 60(1): 155:
The use of a hematology analyzer with a new generation of software as an alternative to flow cytometry for enumerating residual white blood cells in blood components.
What we see as the essence:
In this study, the performance of the XN Blood Bank (BB) mode for residual WBC (rWBC) enumeration in blood components was analysed. In platelet, plasma and RBC components spiked with WBC, the BB mode demonstrated a LOQ of 2 WBC/μL and an excellent concordance with flow cytometry (FC) results. In components obtainend from a routine blood bank, the BB mode successfully identified leukodepletion failures and met the guideline criteria of 90% of tested components containing less than 1x10^6 rWBC/unit, which was in agreement with FC results.

Flagging

Schuff-Werner P et al. (2016) Clin Chem Lab Med; 54(9): 1503:
Performance of the XN-2000 WPC channel-flagging to differentiate reactive and neoplastic leucocytosis.
What we see as the essence:
The XN-1000 demonstrated an excellent performance for differentiation between neoplastic and reactive leukocytosis.
Jones AS et al. (2015) J Clin Pathol; 68: 161:
The value of the white precursor cell channel (WPC) on the Sysmex XN-1000 analyser in a specialist paediatric hospital.
What we see as the essence:
The flagging efficiency of the XE-5000 and XN-Series were compared in paediatric blood samples: sensitivity was improved when only the WDF channel of the XN was used while both sensitivity and specificity were improved when also the WPC channel was used.
Hotton J et al. (2013) Am J Clin Pathol; 140: 845:
Performance and Abnormal Cell Flagging Comparisons of Three Automated Blood Cell Counters -Cell-Dyn Sapphire, DxH-800, and XN-2000.
What we see as the essence:
"Repeatability, linearity and carryover was good for all tested analysers, and correlation between the analysers was good for HGB, MCV, PLT and WBC.
Quotes: "The XN showed a higher sensitivity than the SAPH and DxH for all flags of interest." "For the first time, we have decreased the slide review for our laboratory from 20% with the SAPH to 9.3% with the XN."
Briggs CJ et al. (2011) Am J Clin Pathol; 136: 309:
Improved Flagging Rates on the Sysmex XE-5000 Compared With the XE-2100 Reduce the Number of Manual Film Reviews and Increase Laboratory Productivity.
What we see as the essence:
The increased specificity of the XE-5000 eMM (efficient multichannel messaging) flagging reduces the number of manual film reviews, particularly for blast and abnormal lymph flags.

General WBC

Arbiol-Roca A et al. (2018):
Reference intervals for a complete blood count on an automated haematology analyser Sysmex XN in healthy adults from the southern metropolitan area of Barcelona. EJIFCC; 29(1): 48
What we see as the essence:
The aim of the study was to establish reference intervals for CBC, DIFF and reticulocytes for a Spanish population. Significant gender differences were found for RBC, PLT, HCT and HGB.
Cao J et al. (2017):
Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.Lab Med; 48(2): 188
What we see as the essence:
The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims
Cornet E et al. (2016) Scand J Clin Lab Invest; 76(6): 465:
Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC).
What we see as the essence:
Using the biomedical validation criteria, 21.3 % of samples triggered
a smear review. Modification of four criteria reduced the number of smears from 21.3 % to 15.0 % without loss of clinical value.
Van Dievoet MA et al. (2016) Int J Lab Hematol; 38(5): 490:
Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000. Int J Lab Hematol early online
What we see as the essence:
"The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser."
Tabe Y et al. (2015) Clin Chem Lab Med; 53(2): 281:
Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system.
What we see as the essence:
This performance evaluation of the digital imaging analyser DI-60 showed a good agreement between results from the DI-60 and manual microscopy. In addition, blasts were correctly classified with 95 % sensitivity and 99 % specificity.
Arneth B et al. (2015) J Clin Lab Anal; 29(3): 175:
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
What we see as the essence:
This paper gives a good overview of the technology behind the
XE-series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers.
Bruegel M et al. (2015) Clin Chem Lab Med 53(7): 1057:
Comparison of five automated hematology analyzers in a university hospital setting: Abbott Cell-Dyn Sapphire, Beckman Coulter DxH 800, Siemens Advia 2120i, Sysmex XE-5000, and Sysmex XN-2000
What we see as the essence:
A comparison of Abbott, Beckman Coulter, Siemens and Sysmex analysers found superior flagging performance of the XN-2000, especially for blasts and variant lymphocytes. Otherwise, the analysers were comparable.
Genevieve F et al. (2014):
Smear microscopy revision: propositions by the GFHC. feuillets de Biologie VOL LVI N° 317
What we see as the essence:
The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.
Kawauchi S et al. (2013) Sysmex J Int; 23(1): 1:
The Positions of Normal Leukocytes on the Scattergram of the Newly Developed Abnormal Cell-detection Channel of the XN-Series Multi-parameter Automated Hematology Analyzers.
What we see as the essence:
Using purified leukocyte populations, the paper confirms the position of those populations within the WPC scattergrams. Interestingly, two populations of lymphocytes with a different resistance to WPC reagents were found.
Briggs C et al. (2012) J Clin Pathol; 65: 1024:
Performance evaluation of the Sysmex haematology XN modular system.
What we see as the essence:
The XN showed reduced sample turnaround time and reduced number of blood film reviews than the XE-2100 without loss of sensitivity and with more precise and accurate results for both platelets and low WBC counts.

Granulocytes

Huang Y et al. (2019) Multicenter Study; 50: 303:
Immature granulocytes: A novel biomarker of acute respiratory distress syndrome in patients with acute pancreatitis.
What we see as the essence:
Neutrophil fluorescence intensity (NEUT-RI) in blood samples of patients with septic shock was significantly higher in septic shock-induced disseminated intravascular coagulation (DIC) patients compared with non-DIC septic shock patients (70.0 vs. 50.7 FI).
Ustyantseva M et al. (2019) Sysmex Journal International; 29(1): 8:
Innovative Technologies in the Evaluation of the Neutrophil Functional Activity in Sepsis.
* Free online after free registration
What we see as the essence:
The study revealed significantly higher values of neutrophil fluorescence intensity (NEUT-RI) in critically ill patients with sepsis (NEUT-RI = 70 FI) compared to the non-septic control group (NEUT-RI = 53 FI). Furthermore, strong correlations between the levels of NEUT-RI and generally recognized biomarkers of sepsis (PCT, CRP) were found.
Porizka M et al. (2019) Interact Cardiovasc Thorac Surg; 28(6): 845:
Immature granulocytes as a sepsis predictor in patients undergoing cardiac surgery.
* Free online after free registration
What we see as the essence:
Porizka et al. investigated the ability of IG, Procalcitonin (PCT), WBC, body temperature and combinations in a cohort of cardiac surgery patients for the ability to identify sepsis. IG and PCT exhibited an AUC of 0.71 and 0.72, whereas in combination AUC increased to 0.8. IG is considered as a valuable additional parameter to PCT that improves sepsis identification in this special patient cohort.
Ünal Y et al. (2018) Ulus Travma Acil Cerrahi Derg; 24(5): 434:
A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes.
What we see as the essence:
IG# is a more reliable marker in predicting acute appendicitis than WBC, neutrophil lymphocyte ratio (NLR) and IG%, whereas IG% is more reliable in discriminating simple and complicated appendicitis.
Delabranche X et al. (2017) J Crit Care; 47(3): 313:
Evidence of Netosis in Septic Shock-Induced Disseminated Intravascular Coagulation.
What we see as the essence:
Neutrophil fluorescence intensity (NEUT-RI) in blood samples of patients with septic shock was significantly higher in septic shock-induced disseminated intravascular coagulation (DIC) patients compared with non-DIC septic shock patients (70.0 vs. 50.7 FI).
Ronez E et al. (2017) Scand J Clin Lab Invest;77(6): 406:
Usefulness of thresholds for smear review of neutropenic samples analyzed with a Sysmex XN-10 analyzer.
What we see as the essence:
A multi-center study showed that 1031 smear reviews triggered by isolated neutropenic samples (NEUT# < 1.5 G/L) resulted in the detection of only one positive sample (containing blasts). The authors recommend to use a lower cutoff of 1.0 G/L for smear review.
Hampson P et al. (2017) Ann Surg; 265(6): 1241:
Neutrophil Dysfunction, Immature Granulocytes, and Cell-free DNA are Early Biomarkers of Sepsis in Burn-injured Patients: A Prospective Observational Cohort Study.
What we see as the essence:
Neutrophil and IG counts correlated with sepsis risk in burn patients.
They could be used as predictive markers of sepsis in burn patients together with other markers such as the phagocytic index and cell free DNA.
Stiel L et al. (2016) Crit Care Med; 44(11): e1132:
Neutrophil Fluorescence: A New Indicator of Cell Activation During Septic Shock-Induced Disseminated Intravascular Coagulation.
What we see as the essence:
Neutrophil fluorescence (NEUT-RI) above 57.3 FI had a sensitivity of 90.9 % and a specificity of 80.6 % for diagnosis of disseminated intravascular coagulation in patients with septic shock.
Park SH et al. (2015) Int J Lab Hematol; 37(2): 190:
Sepsis affects most routine and cell population data (CPD) obtained using the Sysmex XN-2000 blood cell analyzer: neutrophil-related CPD NE-SFL and NE-WY provide useful information for detecting sepsis.
What we see as the essence:
NE-SFL and NE-WY parameters have a good potential as sepsis markers and have a high specificity and sensitivity to differentiate between sepsis and non-sepsis groups.
Ha SO et al. (2015) Scand J Clin Lab Invest; 75(1): 36:
Fraction of immature granulocytes reflects severity but not mortality in sepsis.
What we see as the essence:
Sepsis patients with an IG count on the XE-2100 of more than
0.5 % were more likely to suffer from severe sepsis or septic shock, while WBC, CRP and PCT were not predictive of sepsis severity. None of the tested markers could predict 28-day mortality.
Cornet E et al. (2015) Int J of Lab Hematol.: 37(5): e123:
Contribution of the new XN-1000 parameters NEUT-RI and NEUT-WY for managing patients with immature granulocytes.
What we see as the essence:
Normal values were determined on the XN-Series for the structural neutrophil parameters NEUT-GI, NEUT-RI and NEUT-WY. In addition, it was shown that NEUT-RI and NEUT-WY can be used to predict IG% values within a 72 h time frame.
Zimmermann M et al. (2015) Clin Lab; 61: 235:
Detection and quantification of hypo- and hypergranulated neutrophils on the new Sysmex XN hematology analyzer: establishment of an adapted reference interval for the neutrophil-granularity-intensity compared to XE-technology in adult patients.
What we see as the essence:
The reference intervals for NEUT-GI (XN-Series) and NEUT-X
(XE-series) were determined using 246 blood-healthy control patients: 140.91 - 160.46 channels and 129.20 - 142.33 channels, respectively. Neutrophil granularity was higher in ICU patients.
Wiland EL et al. (2014) Acta Paediatr.: 103(5): 494.:
Adult and child automated immature granulocyte norms are inappropriate for evaluating early-onset sepsis in newborns.
What we see as the essence:
"A study on the XE-5000 showed that IG counts were increased during the first 2 days after birth. Therefore, the authors conclude that the use of adult and child norms for IG% is not appropriate for newborns when evaluating early-onset sepsis."
Nierhaus A et al. (2013) BMC Immunology 14: 8:
Revisiting the white blood cell count: immature granulocytes count as a diagnostic marker to discriminate between SIRS and sepsis - a prospective, observational study.
What we see as the essence:
"Direct quote: Our findings demonstrate that sepsis is associated with an increased immature granulocyte count. The IG count can differentiate between patients with an infection and those who are not infected, particularly within the first critical hours after an initial SIRS alert. Using ROC analysis we found the IG count a superior biomarker for sepsis compared to C-reactive protein, lipopolysaccharide binding protein and interleukin-6."
Cimenti C et al. (2012) Clin Chem Lab Med; 50: 1429:
The predictive value of immature granulocyte count and immature myeloid information in the diagnosis of neonatal sepsis.
What we see as the essence:
Compared to a manual smear review, automated detection of IG # and IMI # represents a fast, accurate and less labour-intensive method and could improve screening and monitoring for early onset sepsis in neonates.
Roehrl MHA et al. (2011) Arch Pathol Lab Med; 135: 471:
Age-dependent reference ranges for automated assessment of immature granulocytes and clinical significance in an outpatient setting.
What we see as the essence:
The use of appropriate reference ranges makes the IG count a powerful haematologic parameter for outpatient care that is associated with differential diagnoses that are distinctly characteristic of that setting.
Zimmermann M et al. (2011) Clin Chem Lab Med; 49: 1193:
Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases.
What we see as the essence:
The Granularity Index (GI) is suited to quantify the degree of toxic granulation of neutrophils. The GI is a parameter calculated from automated, standardised measurements. The authors suggest that it should replace the time-consuming and subjective microscopic procedure
Le Roux G et al. (2010) Int J Lab Hematol; 32: e237:
Routine diagnostic procedures of myelodysplastic syndromes: value of a structural blood cell parameter (NEUT-X) determined by the Sysmex XE-2100™.
What we see as the essence:
"NEUT-X and the calculated granularity index GI help to screen for myelodysplastic syndromes (MDS) with increased sensitivity without increasing unnecessary smears."
Furundarena JR et al. (2010) Int J Lab Hematol 32: 360–366.:
The utility of the Sysmex XE-2100 analyzer's NEUT-X and NEUT-Y parameters for detecting neutrophil dysplasia in myelodysplastic syndromes.
What we see as the essence:
"The parameters NEUT-X and NEUT-Y can be used to detect neutrophil dysplasia arising from MDS and chronic myelomonocytic leukaemia (CMML)."
Linssen J et al. (2008) Cytometry B (Clin Cytometry); 74: 295:
Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro.
What we see as the essence:
Fluorescence flow cytometry can measure activation steps of monocytes and polymorphonuclear neutrophils to defined external stimuli. This may potentially be applied as a screening and surveillance method for inflammatory diseases.
Fernandes B (2007) Am J Clin Pathol; 128: 454:
Automated enumeration of immature granulocytes.
What we see as the essence:
The results indicate that the automated IG count can replace the manual morphology count and is superior to it.
Ansari-Lari A et al. (2003) Am J Clin Pathol 120: 795–799.:
Immature granulocyte measurement using the Sysmex XE-2100. Relationship to infection and sepsis.
What we see as the essence:
"The automated IG count matches the manual IG count very well. At significantly elevated levels, it is a very specific predictor of sepsis. Multiparameter algorithms might be more successful at lower concentrations."
Briggs C et al. (2000) Clin Lab Haematol; 22: 345:
New quantitative parameters on a recently introduced automated blood cell counter – the XE 2100.
What we see as the essence:
The IG count correlated with visual counts thus potentially improving screening and monitoring of various pathological conditions and reducing turnaround time.

HFLC

Linssen J et al. (2007) Cytometry B (Clin Cytometry) 72: 157:
Identification and quantification of high fluorescence-stained lymphocytes as antibody synthesizing/secreting cells using the automated routine hematology analyzer XE-2100.
Reprinted in: Sysmex J Int 19(1): 19 http://scientific.sysmex.co.jp/en
What we see as the essence:
The Sysmex high-fluorescence lymphocyte count quantifies activated B-lymphocytes with high precision and reliability in patients without haematological systemic diseases, thus providing a potential screening and monitoring tool for a suspected infection.

Low WBC mode

SEO JY et al. (2015) Int J Lab Hematol; 37(2): 155:
Performance evaluation of the new hematology analyzer Sysmex XN-series.
What we see as the essence:
A good correlation was found between the XN- and XE-series
for all parameters. The XN-Series dramatically reduced the smear rate (by 58 %). Even at counts below 500/µL the XN provided an accurate WBC count using the Low WBC mode.
Tanaka Y et al. (2014) Int J Hematol. 36(4): e50:
Elimination of interference by lipids in the Low WBC mode in the automated hematology analyzer XN-2000.
What we see as the essence:
"The study shows that potential interferences by the contamination of lipids have been eliminated in the two leukocyte channels of the XN-series, particularly compared to non-fluorescent methods. Furthermore, the new Low WBC mode showed better precision for leukopenic samples than the whole blood (WB) mode."

Lymphocytes

Paridaens H et al. (2019) Ann Biol Clin (Paris); 77(4): 422:
Can the 72-hour rule based on "Blast/Abn Lymph" flag on Sysmex XN-10 optimize the workflow in hematology laboratory?
What we see as the essence:
The authors verified GFHC rules for reducing unnecessary smears and even extended the rules for further smear reduction when using XN analysers. The very good sensitivity (93%) and specificity (94%) of the Blast/Abn Lympho? flag was confirmed in line with smear reduction of 5.7% and associated cost reduction.
Henriot l et al. (2017) Int J Lab Hematol; 39(1): 14:
New parameters on the hematology analyzer XN-10 (SysmexTM) allow to distinguish childhood bacterial and viral infections.
What we see as the essence:
New parameters from the Sysmex XN allowed to differentiate between inflammation and infection in children. The parameter AS-LYMP (AUC=0.83) had the same discrimation power as procalcitonin (AUC=0.82) to distinguish between bacterial and viral infections.
Oehadian A et al. (2015) Int J Lab Hematol; 37(6): 861:
New parameters available on Sysmex XE-5000 hematology analyzers contribute to differentiating dengue from leptospirosis and enteric fever.
What we see as the essence:
The detection of atypical lymphocytes, high-fluorescent lymphocytes and immature granulocytes on the XE-5000 supports the differentiation between common causes of febrile illnesses with thrombocytopenia in dengue areas.
Brisou G et al. (2015) J ClinLab Anal: 29(2): 153:
Alarms and Parameters Generated by Hematology Analyzer: New Tools to Predict and Quantify Circulating Sezary Cells.
What we see as the essence:
"Combining the 'Blasts/Abn Lympho?' flag with the Ly-X and Ly-Y parameters it was possible to differentiate Sezary patients from control patients (sensitivity 89%; specificity 98%) or from patients with chronic lymphoproliferative diseases (sensitivity 89%; specificity 94%). The proposed algorithm may alert the microscopist that a sample likely contains Sezary cells."
Van Mirre E et al. (2011) Clin Chem Lab Med; 49: 685:
Sensitivity and specificity of the high fluorescent lymphocyte count-gate on the Sysmex XE-5000 hematology analyzer for detection of peripheral plasma cells.
What we see as the essence:
The Sysmex XE-5000 is suitable for screening blood samples for the presence of elevated numbers of plasma cells in peripheral blood.
Linssen J et al. (2007) Cytometry B (Clin Cytometry) 72: 157–166. Reprinted in: Sysmex J Int 19(1): 19–25.:
Identification and quantification of high fluorescence-stained lymphocytes as antibody synthesizing/secreting cells using the automated routine hematology analyzer XE-2100.
What we see as the essence:
"The Sysmex high-fluorescence lymphocyte count quantifies activated B-lymphocytes with high precision and reliability in patients without haematological systemic diseases, thus providing a potential screening and monitoring tool for a suspected infection."

Monocytes

Zhu J et al. (2019) Int J Lab Hematol; 41(6): 782:
A hierarchical approach in the diagnostic workflow of chronic myelomonocytic leukemia: Pivotal role of the "Mono-dysplasia-score" combined with flow cytometric quantification of monocyte subsets.
What we see as the essence:
The authors set up a workflow for monocytosis samples including Mono-dysplasia score, smear review and flow cytometry. Mono-dysplasia score was shown to be a valuable filter for reducing the number of smears without losing sensitivity for CMML suspicious samples.
Buoro S et al. (2018) Int J Lab Hematol; 40(5): 577:
Evaluation and comparison of automated hematology analyzer, flow cytometry, and digital morphology analyzer for monocyte counting.
What we see as the essence:
Comparison of the XN-9000, CyFlow Space System and DI-60 compared with OM (optical microscopy) for the monocyte count revealed a better performance and higher values for flow cytometry than OM and DI-60 which have also a higher imprecision. The authors conclude also that the absolute monocyte count may be more reliable.
Schillinger F et al. (2017) Scand J Clin Lab Invest; 78(3):159:
A new approach for diagnosing chronic myelomonocytic leukemia using structural parameters of Sysmex XN analyzers in routine laboratory practice.
What we see as the essence:
A score derived from Sysmex XN parameters identifies possible CMML samples by excluding reactive monocytes. This reduces the smear review work load.
Mazumdar R et al. (2013) Leukemia Research; 37(6): 614:
The automated monocyte count is independently predictive of overall survival from diagnosis in chronic lymphocytic leukaemia and of survival following first-line chemotherapy.
What we see as the essence:
A monocyte count >0.91 ×109/L at the time of diagnosis was associated with a shortened overall and treatment-free survival in CLL patients.

NEUT-X / NE-SSC, NEUT-Y / NE-SFL

Cornet E et al. (2015):
Contribution of the new XN-1000 parameters NEUT-RI and NEUT-WY for managing patients with immature granulocytes. Int J of Lab Hematol.: 37(5): e123
What we see as the essence:
"Normal values were determined on the XN-Series for the structural neutrophil parameters NEUT-GI , NEUT-RI and NEUT-WY. In addition, it was shown that NEUT-GI and NEUT-WY can be used to predict IG% values within a 72 h time frame."
Zimmermann M et al. (2015):
Detection and quantification of hypo- and hypergranulated neutrophils on the new Sysmex XN hematology analyzer: establishment of an adapted reference interval for the neutrophil-granularity-intensity compared to XE-technology in adult patients.Clin Lab 61: 235–241.
What we see as the essence:
"The reference intervals for NEUT-GI (XN-Series) and NEUT-X (XE-Series) were determined using 246 blood-healthy control patients: 140.91 - 160.46 channels and 129.20 - 142.33 channels, respectively. Neutrophil granularity was higher in ICU patients."
Zimmermann M et al. (2011):
Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases. Clin Chem Lab Med 49: 1193–1198.
What we see as the essence:
"The Granularity Index (GI) is suited to quantify the degree of toxic granulation of neutrophils. The GI is a parameter calculated from automated, standardised measurements. The authors suggest that it should replace the time-consuming and subjective microscopic procedure."
Le Roux G et al. (2010):
Routine diagnostic procedures of myelodysplastic syndromes: value of a structural blood cell parameter (NEUT-X) determined by the Sysmex XE-2100™. Int J Lab Hematol 32: e237–243
What we see as the essence:
"NEUT-X and the calculated granularity index GI help to screen for myelodysplastic syndromes (MDS) with increased sensitivity without increasing unnecessary smears."
Furundarena J et al. (2010) Int J Lab Hematol; 32: 360:
The utility of the Sysmex XE-2100 analyzer's NEUT-X and NEUT-Y parameters for detecting neutrophil dysplasia in myelodysplastic syndromes.
What we see as the essence:
The parameters NEUT-X and NEUT-Y can be used to detect neutrophil dysplasia arising from MDS and chronic myelomonocytic leukaemia (CMML).
Linssen J et al. (2008):
Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B (Clin Cytometry) 74: 295–309. Free online.
What we see as the essence:
"Fluorescence flow cytometry can measure activation steps of monocytes and polymorphonuclear neutrophils to defined external stimuli. This may potentially be applied as a screening and surveillance method for inflammatory diseases."

XN Stem Cells

Dima F et al. (2020) Blood Transfus; 18(1): 67:
Assessment of haematopoietic progenitor cell counting with the Sysmex® XN-1000 to guide timing of apheresis of peripheral blood stem cells.
What we see as the essence:
The XN Stem cell application can assess the timing of apheresis and thus improve the apheresis workflow by reducing CD34 tests. The parameter shows excellent diagnostic accuracy in different donor subsets, high precision and a very good correlation with CD34.
Furundarena JR et al. (2020) Int J Lab Hematol; 42(2): 170:
Evaluation of the predictive value of the hematopoietic progenitor cell count using an automated hematology analyzer for CD34+ stem cell mobilization and apheresis product yield.
What we see as the essence:
The authors established two decisions trees using XN haematopoietic progenitor cells count for decision making in autologous transplants. One for optimising the rational use of plerixafor in poor mobilisers and the second for decision on the optimal starting point of apheresis.
Grommé M et al. (2017) Transfusion; 57(8): 1949:
Multicenter study to evaluate a new enumeration method for hematopoietic stem cell collection management.
What we see as the essence:
The XN Stem cell method correlates well with the gold standard of CD34 flow cytometry during stem cell mobilisation phase to determine apheresis start time, during apheresis for real-time monitoring and for QC of the final stem cell harvest.
Park SH et al. (2015) Ann Lab Med; 35(1): 146:
The New Sysmex XN-2000 Automated Blood Cell Analyzer More Accurately Measures the Absolute Number and the Proportion of Hematopoietic Stem and Progenitor Cells Than XE-2100 When Compared to Flow Cytometric Enumeration of CD34(+) Cells.
What we see as the essence:
Stem cell counts from the XN-Series were more accurate than stem cell counts from the XE-Series when compared to CD34 flow cytometry.
Peerschke El et al. (2015) Transfusion; 55(8): 2001:
Evaluation of new automated hematopoietic progenitor cell analysis in the clinical management of peripheral blood stem cell collections.
What we see as the essence:
XN-Stem Cells is a functional equivalent of CD34 analysis and may
be a surrogate for CD34 analysis to predict optimal timing of stem cell collections from mobilised peripheral blood.
Tanosaki R et al. (2014) Int J Lab Hematol; 36(5): 521:
Novel and rapid enumeration method of peripheral blood stem cells using automated hematology analyzer.
What we see as the essence:
This study found that CD34-positive cells fall in the XN stem cell gate in the WPC scattergram. The final yield of collected CD34-positive cells could be predicted from the XN-HPC value in pre-apheresis blood and apheresis products.
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