Publications

Sysmex is one of the world’s leading healthcare companies and our aim is to build and share knowledge. This database is targeted at our customers, clinicians from various medical disciplines and researchers as well as any other interested reader. The literature lists with publications from scientific journals give a comprehensive overview on available evidence for Sysmex products and solutions.

Blood Bank Mode

General

Rabcuka J et al. (2022) Acta Haematol; 6(18): 5415:
Metabolic reprogramming under hypoxic storage preserves faster oxygen unloading from stored red blood cells.
Summary:
In this study, relative to standard blood bank storage protocols, hypoxic storage preserves faster O2 unloading from red blood cells in RBC units stored up to 35 days. The effect correlated with Sysmex XN RBC side-scatter (RET-RBC-Z) from RET channel.
Arisawa F et al. (2021) Sysmex J Int; 31(2): 18:
Evaluation of the Blood Bank mode Software of Sysmex XN-1000 Hematology Analyzer for Counting Residual Red Blood Cells and Platelets in Platelet concentrates, and Residual White Blood Cells in Leucocyte-Reduced Whole Blood
Summary:
The study investigated Blood Bank mode (XN-1000) analytical performance of rRBC (0-5000/µL), rWBC (0-30/µL) with standard blood components counting methods and the PLT correlation with XS-1000i. The authors suggested due to the comparable results that it is possible to measure rRBC, rWBC, and platelet counts for quality control in one sample using the Blood Bank mode.
Bell S et al. (2021) Transfus Med 31(2): 94:
Comparison of four methods to measure haemoglobin concentrations in whole blood donors (COMPARE): A diagnostic accuracy study.
Summary:
Four haemoglobin measurement methods in 21.840 blood donors recruited from 10 NHSBT centres in England were investigated against reference (XN analyser). The proportion of donors who would have been inappropriately bled ranged from 2.2% to 18.9%. The proportion of donors who would have been deferred incorrectly with haemoglobin concentration above the minimum threshold ranged from 0.1% to 20.3%.

Residual Red Blood Cells

Cavagnetto C et al. (2021) Transfusion; 61(2): e258:
Residual red cells in blood components: A multisite study of fully automated enumeration using a hematology analyzer.
Summary:
In this study, the Blood Bank mode was tested at multiple sites and showed very good performance characteristics, with an LoD/LoQ of 6 RBC/µL and excellent linear correlation between expected and observed values in spiking experiments. Moreover, in a batch of routine manufactured blood components the Blood Bank mode identified all residual RBC contaminated samples correctly.

Residual White Blood Cells

Genicco A et al. (2023) La Rivista Italiana della Medicina di Laboratorio; 19(1): 30:
Verification of leukocyte contamination in leucodepleted blood components using Blood Bank mode of Sysmex XN-1000 haematology analyzer.
Summary:
The authors found that the residual WBC counting methods ADAM and the XN Blood Bank mode had an agreement of 100% for K2EDTA samples. Both methods exhibited excellent linearity and precision results and adequate limit of quantification values. The bias between XN BB mode and ADAM increased slightly over storage time. Performance of residual RBC count on XN BB mode was in agreement with results published by Cavagnetto et al. in 2021.
Mack S et al. (2020) Transfusion; 60(1): 4:
Component residual white blood cell counting made easy?
Summary:
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.
Lagerberg JW et al. (2020) Transfusion; 60(10): 2456:
Improved accuracy in counting residual white blood cells in red cell concentrates using new blood bank mode software of SYSMEX XN-1000 hematology analyzer.
Summary:
The authors re-calculated their results with the updated XN software for Blood Bank mode and observed a very good linear fit between expected and observed values for residual WBC in red cell concentrates (RCC). The previous underestimation of residual WBC in RCC (Blanco RA et al.) was solved with the updated XN software (XN IPU SW 22.15).
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.
Summary:
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 obtained 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.
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).

Original articles

Jha B et al. (2023) Int J Lab Hematol; 45(3): 282:
Value of new advanced hematological parameters in early prediction of severity of COVID-19.
Summary:
In this prospective observational study the intensive care infection score (ICIS) and the COVID-19 prognostic score showed similar performance in identifying critical illness in a cohort of COVID-19 positive patients (AUC 0.778 and 0.781). All EIP (except for NEUT-GI) exhibited significant differences in critically ill versus non critical patients and RE-LYMP# was found as independent risk factor.
Kilercik M et al. (2021) PloS ONE; 16(8) e0254073:
A new haematocytometric index: Predicting severity and mortality risk value in COVID-19 patients.
Summary:
This retrospective analysis of 97 COVID-19 positive patients identified monocyte-to-neutrophil ratio (MNR), MCV, RDW, and PLT as independent risk factors for mortality. A mortality risk score comprised of MNR, neutrophil-to-lymphocyte ratio (NLR), RDW, and PLT achieved an AUC of 0.91 and a specificity of 0.94.
Boulanger M et al. (2021) Am J Med; 134(8): 1029:
Peripheral Plasma Cells Associated with Mortality Benefit in Severe COVID-19: A Marker of Disease Resolution.
Summary:
This multicentric study investigated the association of plasma cells (HFLC) in peripheral blood of severe COVID-19 patients for morbidity. Retrospective analysis showed that patients exhibiting plasma cells were more likely to develop severe disease but also had a reduced risk of death. In most patients plasma cells appeared after progression to severe disease and, thus, will not serve as an early marker for severe disease.
Cohen A et al. (2021) J Thromb Thrombolysis; 52(3): 708:
Immature platelets in patients with Covid‑19: association with disease severity.
Summary:
In this study of patients with COVID-19 patients (56 mild cases, 80 severe) showed that immature platelet parameters (IPF, IPF# and maximal IPF#) were elevated in severe disease. Maximal IPF# was an independent prognostic factor for prolonged hospitalisation length.
Incir S et al. (2021) Turk J Biochem; 46(4): 359:
Immature platelet fraction: is a novel early predictive marker for disease severity in patients with Covid-19 pneumonia?
Summary:
This study of COVID-19 patients (110 non-severe cases, 44 severe) showed that IPF at admission was higher in severe disease. IPF was an independent predictor for disease severity with an AUC of 0.88 at a cut-off of > 9.5% (sensitivity 69.5% and specificity 92.4%).
Urrechaga E et al. (2021) Scand J Clin Lab Invest; 81(5): 394:
Leukocyte differential and reactive lymphocyte counts from Sysmex XN analyzer in the evaluation of SARS-CoV-2 infection.
Summary:
This prospective observational study aimed to assess the diagnostic performance in distinguishing SARS-CoV-2 infections from other viral or bacterial infections in emergency room (ER) patients presenting with fever. NLR > 3.3 and RE-LYMP >0.6% correctly distinguished 95.6% of SARS-CoV-2 infection patients in the validation group (bacterial and viral infected ER patients).
Martens R et al. (2021) Clin Chem Lab Med; 59(4): 783:
Hemocytometric characteristics of COVID-19 patients with and without cytokine Storm syndrome on the Sysmex XN-10 hematology analyzer.
Summary:
The study’s results on the haemocytometric characteristics of COVID-19 patients revealed that a cytokine-storm syndrome was associated with higher AS-LYMPH, RE-MONO and monocyte fluorescence.
Dennison D et al. (2021) Int J Infect Dis; 106: 155:
Circulating activated neutrophils in COVID-19: An independent predictor for mechanical ventilation and death.
Summary:
The authors found that in multivariable regression analyses NEUT-RI (OR = 1.22) was a statistically significant predictor at admission for a later need of mechanical ventilation and death in COVID-19 positive patients among others. NEUT-RI cut-off value for mechanical ventilation was 52 FI (44% sensitivity, 88% specificity; AUC= 0.67).
Foy B et al. (2020) JAMA Netw Open; 3(9): e2022058:
Association of Red Blood Cell Distribution Width With Mortality Risk in Hospitalized Adults With SARS-CoV-2 Infection.
Summary:
A retrospective analysis from four US hospitals associated an elevated red cell distribution width (RDW) at admission and an increasing RDW during hospitalisation with increased mortality risk in COVID-19 patients, and identified RDW as an independent mortality risk factor.
Rolla R et al. (2020) Int J Lab Hematol; 43(1): e5:
Reduced activity of B lymphocytes, recognised by Sysmex XN-2000™ haematology analyser, predicts mortality in patients with coronavirus disease 2019.
Summary:
In this study, the antibody-synthesizing lymphocyte count (AS-LYMP#) together with age, C-reactive protein (CRP) and creatinine level was identified by the authors of this study as an independent predictor of in-hospital mortality in COVID-19 patients.
Lapic I et al. (2020) Int J Lab Hematol; 43(2): e64:
Cell population data: Could a routine hematology analyzer aid in the differential diagnosis of COVID-19.
Summary:
This letter to the editor describes the detailed analysis of cell population data (CPD) from an XN-1000 in COVID-19 and non-COVID-19 patients. CBC parameters do not present with significant differences. The CPD parameters present with significant differences, with the most pronounced the elevated LY-WZ.
Urrechaga E et al. (2020) Clin Chem Lab Med; 59(2): e57:
Complete blood counts and cell population data from Sysmex XN analyser in the detection of SARS-CoV-2 infection.
Summary:
This letter to the editor describes a categorisation of patients with infection/fever into distinct groups based on statistical analyses of complete blood count and cell population data (CPD) from an XN analyser. 93.5% of COVID-19 patients and 100% of non-COVID-19 patients were correctly classified. The authors suggested a flag for COVID-19 infection, based on the neutrophil-to-lymphocyte ratio (NLR) and CPD values.
Santotoribio J et al. (2020) Clin. Lab; 66(9):
Evaluation of Routine Blood Tests for Diagnosis of Suspected Coronavirus Disease 2019.
Summary:
This descriptive diagnostic study evaluated several routine blood tests for the diagnosis of COVID-19 at hospital admission. Lymphocytes, eosinophils, ferritin, LDH, D-dimer and hsCRP were included in the diagnostic criteria that identified suspected COVID-19 patients with a sensitivity of 91% and a specificity of 47%.
Cohen A et al. (2020) J Thromb Thrombolysis; 30: 1:
Immature platelets in patients hospitalized with Covid-19.
Summary:
Patients with COVID-19 have increased immature platelets parameters (IPF, IPF#) compared to stable patients with cardiovascular risk factors. As the disease progresses IPF and IPF# are increased also compared to acute myocardial infarction patients.
Linssen J et al. (2020) Elife; 9: e63195;:
A novel haemocytometric COVID-19 prognostic score developed and validated in an observational
multicentre European hospital-based study.
Summary:
The intention of the prognostic score is to support the management of COVID-19 patients. In this study, score values generated within the first three days of hospital admission could predict clinical severity in COVID-19 patients over the next two weeks. The score performance was shown to be superior to single parameters or parameter ratios.
Osman J et al. (2020) Br J Haematol; 190(5): 718:
Rapid Screening of COVID-19 Patients by White Blood Cells Scattergrams, a Study on 381 Patients.
Summary:
The authors of this study investigated a specific pattern of WDF scattergram, the “sandglass shape” pattern of lymphocyte population in a cohort of 381 patients. It 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.
Summary:
According to the results of this study, the authors indicate 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; 190(2): e76:
High-fluorescent lymphocytes are increased in patients with COVID-19.
Summary:
This 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.
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.
Summary:
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.

Review articles

Khartabil TA et al. (2020) Crit Rev Clin Lab Sci; 57(6): 415:
A summary of the diagnostic and prognostic value of hemocytometry markers in COVID-19 patients.
Nokhostin F et al. (2020) J Adv Med Biomed Res; 28(128): 171:
Evaluation of Prognostic/Diagnostic Value of Hematological Markers in the Detection of Inflammation in Coronavirus Disease: A Review Study.

Single case reports

ZHANG B et al. (2020) PLOS ONE. 15(7): e0235458:
Clinical characteristics of 82 cases of death from 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; 95(8): 999:
Leukoerythroblastic Reaction in a Patient With COVID-19 Infection.
Platelets

Fluorescence platelets (PLT-F)

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.
Summary:
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 under transfusion. Additionally, the authors found that a high blast count is associated with inaccurate PLT-LH and PLT-I counts.
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.
Summary:
PLT-I, PLT-O and PLT-F were compared with CD41/CD61 immune flow cytometry in thalassaemia patients. PLT-O and PLT-F had better correlations with flow cytometry than PLT-I and PLT-F had a better specificity for detection of PLT counts below 100,000/μL in this study.
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.
Summary:
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 in this study.
Wada A et al. (2015) PLoS One; 10(10):
Accuracy of a New Platelet Count System (PLT-F) Depends on the Staining Property of Its Reagents.
Summary:
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.
Summary:
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 in this evaluation study.
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.
Summary:
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) Am J Clin Pathol;140: 495:
New fluorescent method (PLT-F) on Sysmex XN2000 hematology analyzer achieved higher accuracy
in low platelet counting.
Summary:
The PLT-F method of the XN-2000 demonstrated excellent reproducibility in samples with low platelet counts. Therefore, the authors recommended it for making decisions about platelet transfusions.

General

Lunde HE et al. (2022) Int J Lab Hematol; 44(5): 854:
The diagnostic accuracy of Sysmex XN for identification of pseudothrombocytopenia using various thresholds for definition of platelet aggregation.
Summary:
The diagnostic accuracy of the flag PLT Clumps from PLT-F channel for identification of pseudothrombocytopenia was very high (AUC = 0.97) and superior to the WNR/WDF channel (AUC = 0.57) in samples with platelet count <150 x 10^9/L and a moderate to high number of aggregates in the smear.
Shaikh MS et al. (2021) Int J Lab Hematol; 43(3): e141:
Ensuing adequate mixing of blood samples before analysis—A proposed method for verification of satisfactory sample mixing by automated red blood cell count analyzers.
Summary:
The authors report an excellent correlation (r value of 0.99) between manual and automated blood sample mixing with a minimal bias (0.009), proving an exceptional pre-analysis mixing of samples on the XN-1000 analyser.
Ortiz A et al. (2020) Sysmex J Int; 30(1): 9:
Performance Comparison of Sysmex Hematology Analyzers XN-550 and XN-10.
Summary:
According to the authors 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%). In this study the overall flagging comparison was excellent among the XN-10, the XN-550 and the manual differential.
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.
Summary:
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 precision and reportable range were also consistent with specifications by the manufacturer.
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).
Summary:
Using the biomedical validation criteria, 21.3 % of samples triggered a smear review in this study. Modification of four criteria reduced the number of smears from 21.3 % to 15.0 % without losing 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.
Summary:
The XP-300 showed very good precision and linearity results in this study, comparable with the XN-3000 analyser.
SEO JY et al. (2015) Int J Lab Hematol; 37(2): 155:
Performance evaluation of the new hematology analyzer Sysmex XN-series.
Summary:
In this study, 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) J Clin Lab Anal; 29(3): 175:
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
Summary:
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) feuillets de Biologie; VOL LVI N° 317:
Smear microscopy revision: propositions by the GFHC.
Summary:
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.
Briggs C et al. (2012) J Clin Pathol; 65:1024:
Performance evaluation of the Sysmex haematology XN modular system.
Summary:
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.

Immature platelet fraction (IPF)

Anetsberger A et al. (2023) Platelets; 34(1): 2185462:
Association of immature platelets with perioperative complications in neurosurgery.
Summary:
The study on 301 subjects revealed that increased levels of highly fluorescent immature platelets measured postoperatively (H-IPF ≥ 0.95%) are independently associated with an increased risk for serious complications after neurosurgical procedures (odds ratio: OR = 1.97).
Bongiovanni D et al. (2023) Arterioscler Thromb Vasc Biol; 43(2): e83:
Immature Platelet Fraction Predicts Adverse Events in Patients With Acute Coronary Syndrome: the ISAR-REACT 5 Reticulated Platelet Substudy.
Summary:
In acute coronary syndrome treated patients the incidence of the primary end point consisting of death, myocardial infarction or stroke was significantly higher in the IPF-high (IPF>3.6%) group compared to the IPF-low (IPF≤3.6%) group: 13.0% versus 7.2% regardless of the antiplatelet treatment used (prasugrel or ticagrelor).
Kouno H et al. (2023) Int J Lab Hematol; 45(5): 700:
Measurement of immature platelet fraction is useful in the differential diagnosis of MYH9 disorders.
Summary:
The study found that a median IPF of 48.7% in MYH9 disorders was significantly higher than in all other groups (ITP: 13.4%, MDS: 9.4%, control group: 2.6%). The authors concluded that IPF could be a useful supportive parameter in the differential diagnosis between MYH9 disorders and other types of thrombocytopenia.
Bongiovanni D et al. (2022) Arterioscler Thromb Vasc Biol; 42(5): 527:
Role of Reticulated Platelets in Cardiovascular Disease.
Summary:
The authors present a structured overview of preclinical and clinical findings concerning the role of reticulated platelets in cardiovascular disease. They conclude that reticulated platelets with their prothrombic features are a new biomarker that helps to identify patients at high risk for adverse ischemic events.
Jones N et al. (2021) Platelets; 7: 32(7): 941:
Immature platelet indices alongside procalcitonin for sensitive and specific identification of bacteremia in the intensive care unit.
Summary:
The study results demonstrate the predictive power of IPF and IPF# for identification of bacteremia in ICU patients as individual parameters and even more by calculating the change in these parameters between day 1 and 2 of ICU stay (ΔIPF, ΔIPF#). The use of a combination of ΔIPF (cut-off > 1.95%) and day 2 PCT (cut-off > 0.57 ng/ml) has a PPV of 100% and a NPV of 96.1% and thereby accurately ruling out patients from a diagnosis of bacteremia.
Looi K et al. (2021) Int J Inf Dis; 110: 187:
Evaluation of immature platelet fraction as a marker of dengue fever progression.
Summary:
This study evaluated the trend of immature platelet fraction (IPF) as an early recovery indicator of platelets in dengue patients. Patients with severe dengue had higher IPF and stronger thrombocytopenia compared to non-severe dengue. The increase in IPF preceded platelet recovery by at least 3 days.
Jeon MJ et al. (2020) Korean J Intern Med; 35(4): 970:
Immature platelet fraction based diagnostic predictive scoring model for immune thrombocytopenia.
Summary:
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.
Summary:
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover, IPF is presented as 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).
Summary:
This study concluded that IPF and manual schistocyte counts can assist in differentiating pregnancy-associated severe pre-eclampsia/haemolysis, elevated liver enzymes and low platelet syndrome (SPE/HELLP) from thrombotic thrombocytopenic purpura (TTP). 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.
Benlachgar N et al. (2020) Thromb Res; 195: 43:
Immature platelets: a review of the available evidence.
Summary:
The authors summarized literature evidence about IPF%, # focussing on reference values, stability, correlation of IPF and MPV, and contribution of IPF to haematological and non-haematological disorders such as ITP, TTP, disseminated intravascular disorder, aplastic anaemia, MDS and cardiovascular disease, and on IPF in chemotherapy and stem cell transplantation.
Zhao Y et al. (2020) Front Cardiovasc Med; 7: 578041:
The Prognostic Value of Reticulated Platelets in Patients With Coronary Artery Disease: A Systematic Review and Meta-Analysis.
Summary:
This comprehensive meta-analysis presents immature platelets as a potentially useful prognostic biomarker for adverse cardiovascular events in patients with coronary artery disease, even after adjustment for other prognostic factors.
Buttarello M et al. (2020) Int J Lab Hematol; 42(4): 363 (IPF):
Reticulated platelets and immature platelet fraction: Clinical applications and method limitations
Summary:
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.
Summary:
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) 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.
Summary:
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
Summary:
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.
Ali I et al. (2019) Exp Haematol; 78: 56:
Immature platelet fraction as a useful marker in the etiological determination of thrombocytopenia.
Summary:
In this study, the IPF was assessed to determine the aetiology of thrombocytopenia, in a relatively large cohort (n=637). The IPF was significantly higher in cases of increased platelet consumption or pseudothrombocytopenia compared with the control, and was able to discriminate idiopathic thrombocytopenic purpura (ITP) (p<0.05) from other causes of increased platelet consumptive disorders (infection, haemorrhage).
Perl L et al. (2019) Platelets; 17:1:
Prognostic significance of reticulated platelet levels in diabetic patients with stable coronary artery disease.
Summary:
In stable coronary artery disease patients with diabetes the increased level of immature platelets (IPF) show an association 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.
Summary:
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.
Summary:
The authors discussed the role of reticulated platelets in coronary artery disease and in hypo responsiveness to the commonly used anti-platelet drugs. They concluded that 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.
Summary:
The authors concluded that a combination of an increased IPF# value and a decreased RET% value 24 hours before the onset of sepsis in ICU patients can be considered an early, rapid, cost-effective and widely available measure for 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.
Summary:
In this study IPF was able to predict platelet recovery in patients after allogeneic haematopoietic stem cell transplantation in 5 out of 11 patients, while IPF# predicted recovery in 7 out of 11 patients, at cut-offs of 5.8 % and 200/μL, 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.
Summary:
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.
Summary:
In this study, IPF presented as an independent predictor of serious adverse cardiovascular events, deep vein thrombosis or pulmonary embolism (modMACE) after non-cardiac surgery using the optimal cut-off value of > 5.4 % and improves 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.
Summary:
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.
Summary:
In this study an elevated platelet turnover independently predicted major adverse cardiovascular events after percutaneous coronary intervention. The optimal cut-off value was at IPF = 3.35 %.
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?
Summary:
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) Cell Transplant; 25: 1259:
Assessment of platelet activation and immature platelet fraction as predictors of platelet engraftment after hematopoietic stem cell transplantation.
Summary:
In this study IPF (XE-2100) was 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.
Summary:
The review summarises the pathophysiology and current management (including platelet transfusion thresholds) of neonatal thrombocytopenia. A novel index score for bleeding risk in thrombocytopenic neonates was proposed (including IPF#).
Moraes D et al. (2016) Platelets; 27(4): 333:
Immature platelet fraction in hypertensive pregnancy.
Summary:
In this study IPF% measured on the XE-5000 exhibited higher values in pregnant women suffering hypertensive disorders than the control group.
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.
Summary:
In this study absolute IPF count (from XE-5000) was shown to be useful to diagnose and to monitor the clinical course of therapeutic plasma exchange in TTP patients. Routine analysis of absolute IPF count was 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.
Summary:
IPF% (XN-1000) and RP% (flow cytometry) exhibited comparable diagnostic accuracy in differentiating control patients, immune thrombocytopenia, and aplastic thrombocytopenia in this study.
Mao W et al. (2015) Clin Res Hepatol Gastroenterol; 39(4): 469:
Immature platelet fraction values predict recovery of platelet counts following liver transplantation.
Summary:
In this study, the IPF percentage was shown to predict recovery of PLT numbers 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.
Summary:
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.
Summary:
IPF% obtained from the XE-2100 was increased in immune thrombo-cytopenia patients but not in patients with haematological malignancies in this study. The authors therefore suggest using IPF% 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.
Summary:
In this study, both IRF% and IPF% measured on an XE-5000 predicted neutrophil and platelet recovery, respectively.
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.
Summary:
In this study 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.
Ibrahim H et al. (2014) J Am Coll Cardiol; 64: 2122:
Association of Immature Platelets With Adverse Cardiovascular Outcomes.
Summary:
According to this study 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.
Summary:
This study presents IPF as a useful parameter 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.
Summary:
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) Eur J Haematol; 93(2): 150:
Immature platelet fraction (IPF) measured on the Sysmex XN haemocytometer predicts thrombopoietic recovery after autologous stem cell transplantation.
Summary:
Quote: '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.
Summary:
In this study, the IPF count was presented as a suitable parameter for assessing bone marrow activity in transfusion-dependent thrombocytopenic patients.
Cremer M et al. (2013) J Perinatol; 33(8): 622:
Low immature platelet fraction suggests decreased megakaryopoiesis in neonates with sepsis or necrotizing enterocolitis.
Summary:
Low absolute IPF values during the course of neonatal sepsis/necrotising enterocolitis suggest suppression of megakaryopoietic activity according to the study conclusions.
Funck-Jensen K et al. (2013) Platelets; 24(7): 528:
Increased platelet aggregation and turnover in the acute phase of ST-elevation myocardial infarction.
Summary:
Increased platelet turnover, indicated by IPF and MPV, was observed in the acute phase of ST-elevated myocardial infarction in this study and may partly explain reduced efficacy of oral antiplatelet drugs.
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.
Summary:
In this study, reticulated (immature) platelets predicted cardiovascular death independently and improved 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?
Summary:
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.
Summary:
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.
Summary:
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.
Summary:
The use of IPF-rich platelet transfusions reduced the number of transfusions and bleedings after stem cell transplantation in paediatric patients in this study.
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.
Summary:
IPF% supported the differentiation between platelet destruction and bone marrow failure in hepatitis C patients in this study.
Goncalo A et al. (2011) Transplant Proc; 43: 241:
Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients.
Summary:
In this study, immature platelet (IPF) and immature reticulocyte fraction (IRF) were presented as early and readily available assessment methods for post-transplant bone marrow recovery.
Barsam SJ et al. (2011) Blood 117; 5723:
Platelet production and platelet destruction: assessing mechanisms of treatment effect in immune thrombocytopenia.
Summary:
In this study, absolute immature platelet count (IPF#) was shown to reflect the effect of different treatments of immune thrombocytopenia and was in such cases considered 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.
Summary:
Quote: '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.
Summary:
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% value was shown to be an additional indication of a mechanism involved in the increased cardiovascular risk profile of those patients in this study.
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.
Summary:
In this study, IPF above 10% was a useful marker for predicting the timing of platelet recovery after chemotherapy and haematopoietic stem cell transplantation and could allow optimised platelet transfusion.
Cremer M et al. (2009) Br J Haematol 144: 619:
Immature platelet fraction as novel laboratory parameter predicting the course of neonatal thrombocytopenia.
Summary:
In this study, thrombocytopenic neonates were more likely to recover when IPF levels were high.
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
Summary:
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover, IPF was 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.
Summary:
In this study, IPF was presented as an easily available marker for the engraftment after stem cell transplantation, especially regarding thrombopoietic activity.
Abe Y et al. (2006) Thromb Res; 118: 463:
A simple technique to determine thrombopoiesis level using immature platelet fraction (IPF).
Summary:
The results of this study showed that the IPF reflects the pathology of thrombocytopenic disorders (i.e. consumptive versus productive). Measurement of IPF was concluded to be 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.
Summary:
Automated IPF was presented as a useful parameter in the clinical evaluation of thrombocytopenic patients and the authors saw a potential to optimise transfusion management.
Kickler T et al. (2006) Am J Clin Pathol; 125: 282:
A clinical evaluation of high fluorescent platelet fraction percentage in thrombocytopenia.
Summary:
In this study, IPF (here named HFPF for ‘high fluorescence platelet fraction’) was predictive in the evaluation of thrombocytopenia. Elevated IPF values were found in case of increased platelet production, associated with peripheral platelet destruction. In disorders associated with decreased platelet production IPF was found normal.
Briggs C et al. (2004) Br J Haematol; 126: 93:
Assessment of an immature platelet fraction (IPF) in peripheral thrombocytopenia.
Summary:
The authors recommend automated IPF% as a standard parameter in evaluating the thrombocytopenic patient.

Optical platelets (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?
Summary:
In this study different options for counting platelets on XE-2100 were compared using chemotherapy samples. The accuracy of XE-2100 platelet counting was excellent on low-count samples when the switching algorithm was applied.

Reference intervals

Bildirici A et al. (2023) Turk J Biochem; 48(4): 388:
Determination of reference intervals of hemogram with advanced clinical parameters by indirect method on Sysmex XN-1000.
Summary:
The CBC+DIFF reference intervals of 68 316 patients aged 18–65 years were determined by indirect method using the non-parametric percentage estimation in Turkish Kastamonu Training and Research Hospital.
L van Pelt J et al. (2022) Clin Chem Lab Med; 60(6): 907:
Reference intervals for Sysmex XN hematological parameters as assessed in the Dutch Lifelines cohort.
Summary:
The publication provides reference intervals for 105 XN parameters (incl. functional and cell activation parameters) based on data of 15,803 healthy individuals from the Lifelines cohort in the Netherlands. The reference intervals were calculated in accordance to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommended statistical methods.
Becker M et al. (2022) Int J Lab Hematol; 44(4): 729:
Differences between capillary and venous blood counts in children - A data mining approach.
Summary:
In this multicentric study the differences between capillary and venous bloods were investigated in paediatric samples specifying a delta for the CBC parameters dependant on measurement range of the parameter value, time difference in sampling and age of the patient.
Wilson S et al. (2021) Int J Lab Hematol; 43(6): 1394:
Continuous reference curves for common hematology markers in the CALIPER cohort of healthy children and adolescents on the Sysmex XN-3000 system.
Summary:
First study that generated continuous reference intervals (curves) of healthy children and adolescents for 19 haematological XN parameters. Seven parameters required sex-specific reference curves. Continuous reference intervals were found to be accurate estimate of haematological reference ranges over the paediatric age range.
Mrosewski I et al. (2021) Clin Chem Lab Med; 60(3): 408:
Indirectly determined hematology reference intervals for pediatric patients in Berlin and Brandenburg.
Summary:
The study presents indirectly determined CBC reference intervals (RI) for paediatric patients (0-18 years) in Berlin and Brandenburg area in Germany.
Song MY et al. (2021) Int J Lab Hematol; 43(6): 1363:
Establishment of pediatric reference intervals for complete blood count parameters in capillary blood in Beijing.
Summary:
The authors established reference intervals for 22 CBC+DIFF parameters from capillary blood in 6799 children aged 3 months to 18 years from Beijing area in China.
Angelo A et al. (2021) BMC Pediatrics; 21: 275:
Umbilical cord blood hematological parameters reference interval for newborns from Addis Ababa, Ethiopia.
Summary:
This pilot study enrolled 139 umbilical cord blood samples from healthy newborns to establish reference values for the KX-21N. For WBC, RBC, and NEUT significant differences were found between caesarean and natural birth.
Florin L et al. (2020) Int J Lab Hematol; 42(3): e110:
Establishment of common reference intervals for hematology parameters in adults, measured in a multicenter study on the Sysmex XN-series analyzer.
Summary:
The study provides reference intervals (CBC+DIFF+RET) that could serve as reference values for haematology parameters in adults for laboratories that use the XN-Series analysers.
Bohn MK et al. (2020) Int J Lab Hematol; 42(6): 750:
Complex biological patterns of hematology parameters in childhood necessitating age- and sex-specific reference intervals for evidence-based clinical interpretation.
Summary:
The study establishes a comprehensive paediatric (birth to 21 years) reference intervals for haematology parameters using the XN analyser. The data highlight the dynamic haematological profiles observed in healthy children and adolescents and the need for reference interval stratification by age and sex.
Ianni B et al. (2020) Arch Pathol Lab Med; 145(1):66:
Defining Normal Healthy Term Newborn Automated Hematologic Reference Intervals at 24 Hours of Life Arch Pathol Lab Med; Online ahead of print.
Summary:
Reference intervals on Sysmex XN-Series for normal healthy term new-borns at 23-25 hours of life were prospectively established for CBC, IG%, IG#, IRF, RET-He, IPF and IPF#.
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.
Summary:
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.
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.
Summary:
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.
Ozarda Y et al. (2017) Biochem Med (Zagreb); 27(2): 350:
A nationwide multicentre study in Turkey for establishing reference intervals of haematological parameters with novel use of a panel of whole blood.
Summary:
Using the Cell Dyn and Ruby (Abbott), LH780 (Beckman Coulter) and XT-2000i (Sysmex) analysers, Turkish reference intervals were obtained for CBC-DIFF parameters. Analyser-specific reference intervals were reported for BASO%, BASO#, MCHC, RDW and MPV.
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.
Summary:
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.
Ko Y et al. (2013) Int J Lab Hematol; 35(5): 528:
Establishment of reference interval for immature platelet fraction.
Summary:
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 research.
Urinalysis

Biochemistry

Nah et al. (2021) Annals of Public Health Reports 5(1):152-159:
Screening of Chronic Kidney Disease in Primary Health: Comparison of the Urine Dipstick Albumin-to-Creatinine Ratio and Dipstick Proteinuria.
Summary:
The aim of this study was to compare test strip ACR with proteinuria for CKD screening in a primary healthcare setting. This cross-sectional study included 88,479 specimens with ACR and proteinuria was measured on the UC-3500 automated urine test strip analyser. In conclusion, the CKD risk category using test strip proteinuria was underestimated compared to the ACR-based CKD risk category, suggesting a recommendation of the use of test strip ACR for CKD screening in primary healthcare settings.
Currin et al. (2021) BMC Nephrology 22:103:
Diagnostic accuracy of semiquantitative point of care urine albumin to creatinine ratio and urine dipstick analysis in a primary care resource limited setting in South Africa.
Summary:
This study evaluated the diagnostic accuracy of the semi-quantitative albumin-creatinine ratio (ACR) measurement on the UC-1000 at the point of care by determining the sensitivity, specificity, positive predictive value, and negative predictive value of the ACR. The prevalence of albuminuria in the study cohort was 11.6% and accompanied by underlying diseases such as diabetes and hypertension. The performance showed of the ACR measurement showed a sensitivity of 0.79, a specificity of 0.84, a positive predictive value of 0.39 and a negative predictive value 0.97. The sensitivity improved, if including additional information, such as underlying diseases and age. In summary, the study demonstrated a good NPV for ACR at the point of care, offering the potential for frequent screening of risk group patients and reliable rule-out of albuminuria, if screening for CKD.
Oyaert M and Delanghe JR (2019) J Clin Lab Anal 33(5):e22870:
Semiquantitative, fully automated urine test strip analysis.
Summary:
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.
Salinas et al. (2019) Clin Chem Lab Med 57(2):204-209:
Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions.
Summary:
This study aims to evaluate the diagnostic performances of a test strip for measuring ACR for differentiating patients who are candidates for subsequent albumin quantification, and to evaluate the economic effects of its implementation. In conclusion, the detection of albumin and the albumin:creatinine ratio (ACR) is a suitable screening strip test to identify pathological albuminuria for further confirmation through quantitative methods. The performance of the test strip and its workflow benefits do not only foster economic savings, but also elucidates the potential for frequently screening of risk group patients.
Oyaert M et al. (2018) Clin Chem Lab Med 56(7):1126-1132:
Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase.
Summary:
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.
Summary:
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

Shukuya et al. (2023) Practical Laboratory Medicine 23:e00328:
Comparison of the clinical performance of the Atyp.C parameter of the UF-5000 fully automated urine particle analyzer with that of microscopic urine sediment analysis.
Summary:
This study shows that a combination of UF-5000 analysis and microscopic examination of urine sediment improves Atyp.C detection in urine sediment analysis. These results suggest that Atyp.C measured by UF-5000 could be a useful parameter in routine testing of urine samples.
Karaburun et al. (2023) J Med Syst 47(1):41:
Investigation of Atypical Cell Parameter in the Surveillance of Patients with NMIBC; Initial Outcomes of a Single Center Prospective Study.
Summary:
In this prospective study, the Atyp.C parameter demonstrated a potential use in the surveillance of NMIBC patients, showing significantly different values in malignant and non-malignant individuals, as well as between those with high- and low-grade recurrence.
Aydin O (2021) Turk J Biochem; Diagnostic Pathology 16:9:
Atypical cells parameter in Sysmex UN automated urine analyzer: feedback from the field.
Summary:
This study investigates the research parameter “Atypical cells” parameter in context of automated urinalysis to detect cellular atypia as a potential indicator of bladder cancer. In total, 50, mainly female samples with higher than 1 atypical cell/μL result were included in the study with one case of a high-grade urothelial carcinoma. The positive case provided evidence for the capability of the UF-Series to detect atypical cells in urine. The negative cases presented clues that probable vulvovaginal contamination and crowded specimens could be deceptive for this parameter.
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.
Summary:
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.
Summary:
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.
Summary:
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

Baran and Ilki (2023) Clin Lab 69(4):
Evaluation of Sysmex UF-5000-BF Module for Sterile Body Fluids. An Alternative for Conventional Methods?
Summary:
This study highlights the capabilities of the UF-Series Body Fluid mode in automated detection of bacterial cells for rapid prediction of positive body fluid culture results. For CSF, pleural and CAPD fluids, the bacteria count showed a sensitivity of 100 % and a NPV of 100 %, allowing the direct rule-out of negative samples with impact on prevention of unnecessary antibiotic treatments in the sense of antimicrobial stewardship, especially in combination with MALDI-TOFF mass spectrometry for rapid pathogen identification.
Siatkowski M et al. (2022) Clin Chim Acta 531:152-156:
Performance evaluation of UF-4000 body fluid mode for automated body fluid cell counting.
Summary:
This study evaluated the performance of the UF-4000 body fluid mode in comparison to manual light microscopy for ascitic, CSF, pleural, synovial and CAPD fluids. The investigation was executed under real operating conditions within a microbiology laboratory setup and revealed an excellent performance for WBC and RBC counting, reaching 100 % sensitivity and 100 % specificity for most fluids. Especially for ascites the body fluid mode showed the potential to rule-out infections in urgent situations. The outcome of this study highlights the potential of the UF-series body fluid mode for partial replacement of manual body fluid assessment methods. Manual methods might be still required for some cases with abnormal WBC cell counts and scattergram distributions, but overall, positive workflow impacts have been observed.
Dossou N et al. (2022) Microbiology Spectrum 10(1):e0183021:
Evaluation of Flow Cytometry for Cell Count and Detection of Bacteria in Biological Fluids.
Summary:
In the light of diagnostic pathway efficiency for the analysis of body fluids in context of monitoring effusion-causing diseases and the diagnosis of infectious diseases, this study aimed to evaluate the analytical performance (I) of the UF-4000 and the XN-10 as methods for the cytological analysis of different body fluids in comparison to manual counting chambers and manual leukocyte differential counts and (II) of the UF-4000 s a method for the microbiological analysis in comparison with direct Grams staining (DGS) and/or the conventional cultures. Three optimal cut-off values have been defined for the prediction of DGS-positivity for peritoneal (465.0 bacteria/μL), synovial (1200.0 bacteria/μL), and cerebrospinal fluids (17.2 bacteria/μL) with maximum sensitivity and highest negative predictive values. In conclusion, bacterial counts, obtained by flow cytometry on the UF-4000 correlate with direct Gram staining and culture results. The body fluid mode of the UF-Series could thus be used to improve upstream of routine microbiological workflows, aiming the improvement and acceleration of the diagnosis of infectious diseases in biological fluids.
Seghezzi M et al. (2021) Diagnosis (Berl). Online ahead of print.:
Performance evaluation of automated cell counts compared with reference methods for body fluid analysis.
Summary:
This study aimed to evaluate the analytical performance of the UF-5000 body fluid mode in comparison to manual microscopy and the body fluid mode of the XN-1000 for different types of non-CSF body fluids. In conclusion, the UF-5000 body fluid mode shows a very good performance for differential counts of cells in ascitic, pleural and synovial and is thus a suitable and reliable tool in automated body fluid analysis.
Cho J et al. (2020) Ann Lab Med 40(2):122-130:
Performance Evaluation of Body Fluid Cellular Analysis Using the Beckman Coulter UniCel DxH 800, Sysmex XN-350, and UF-5000 Automated Cellular Analyzers.
Summary:
Different types of body fluid specimen were examined using manual counting and three the automated cellular analysers XN-350, UF-5000 and UniCel DxH 800. Additionally, 2,779 BF analysis results were retrospectively reviewed. All three analysers showed good agreement for total nucleated cell (TNC) and red blood cell (RBC) counts, except for the RBC count in CSF samples using the UniCel DxH 800. However, variable degrees of differences were observed during differential cell counting. In conclusion, the three automated analysers showed good analytical performances and proper reflex and interpretation guidelines can help to utilise the generated data.
Koo M et al. (2019) J Lab Med Qual Assur 2019; 41(3): 172-178:
Comparison of Red Blood Cell, White Blood Cell and Differential Counts between UF-5000 System and Manual Method.
Summary:
Analysis of body fluids provides important information for assessing various medical conditions. This study aims to validate the analytical and diagnostic performance of the UF-5000 for the analysis of different body fluids. The performance of RBC counts, WBC counts and differentiation of leucocytes was assessed in comparison to light microscopy for ascitic, pleural, and cerebrospinal and other body fluids. In conclusion, the body fluid application on the UF-5000 proved to be an effective and automated alternative to chamber counting in laboratory routine analysis, thereby enhancing laboratory workflow and clinical effectiveness.
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.
Summary:
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

Debunne et al. (2023) Clin Chem Lab Med, oap:
Urine transfer devices may impact urinary particle results: a pre-analytical study.
Summary:
In this study, the group of Prof. Delanghe investigated the effect of different urine collection methods and the associated urine transfer tubes on urine test strip and particle results. Three different transfer tubes (BD, Greiner, Sarstedt vacuum and Sarstedt aspiration) were used, in comparison to direct measurement on the UF-5000 and UC-3500 analysers. Whereas there were no significant differences found in the test strip results, transfer of urine samples to the secondary tubes affected their particle counts. Clinically significant reductions in counts of renal tubular epithelial cells and hyaline casts were observed using the BD and Greiner transfer tubes and in counts of pathological casts using the BD, Greiner and Sarstedt vacuum tubes. The results of this study indicate that the use of urine transfer tubes may impact counts of fragile urine particles. Clinical laboratories need to be aware about the variation that urine collection methods can induce on urine particle counts.
Antimicrobial Resistance Collaborators (2022) Lancet 399:629-655:
Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis.
Summary:
Antimicrobial resistance (AMR) poses a major threat to human health around the world. Previous publications have estimated the effect of AMR on incidence, deaths, hospital length of stay, and health-care costs for specific pathogen–drug combinations in select locations. To our knowledge, this study presents the most comprehensive estimates of AMR burden to date.
Oyaert M et al. (2022) Clin Chem Lab Med, oap:
Improving clinical performance of urine sediment analysis by implementation of intelligent verification criteria.
Summary:
In this study, urinary diagnostic data, obtained from urinary test strip analysis on the UC-3500 and urinary flow cytometry on the UF-5000 are combined with intelligent verification criteria, aiming to evaluate improvements in diagnostic performance in context of combination of diagnostic data. In summary, the implementation of intelligent verification and review rules improved the diagnostic performance of urinary flow cytometry.
Oyaert M and Delanghe JR (2019) Ann Lab Med 39(2):15-22.:
Progress in Automated Urinalysis.
Summary:
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.

MICROBIOLOGY & ANTIMICROBIAL RESISTANCE

Chen Y et al. (2023) J Infect Chemother 29(7):667-672:
Combination of UC-3500 and UF-5000 as a quick and effective method to exclude bacterial urinary tract infection.
Summary:
This study evaluated the performance of the combination of the UC-3500 and the UF-5000 in screening for bacterial urinary tract infection (UTI). Applying cut-off values of 32.20/μL (male) and 39.15/μL (female) for WBC as well as 22.35/μL (male) and 127.25/μL (female) for BACT allowed effective determination of urinary tract infections. The combiation of WBC, BACT and LEU in a joint screening programs were identified as suitable approach to rapidly and effectively exclude bacterial UTI.
Wang H et al. (2023) PLoS One 18(2):e0281118:
Accuracy of the Sysmex UF-5000 analyzer for urinary tract infection screening and pathogen classification.
Summary:
This study aimed to investigate the screening performance of the UF-5000 for UTI and the BACT Info flag for discrimination of Gram-positive and Gram-negative pathogens. The decision curve showed that urinary bacteria had a higher predictive benefit than WBC with a sensitivity and specificity of the decision tree were 0.69 and 0.95, respectively. The flag of Gram-negative had a positive predictive value (PPV) of 0.93 in patients with urine bacteria > 1367 /μl. In conclusion, urine bacteria determined by the UF-5000 had higher screening performance and greater benefit than WBC. A decision tree can be used to improve the screening performance of routine urinary parameters. The flag of Gram-negative is a reliable indicator to confirm gram-negative bacteria infection in UTI patients.
Yanılmaz Ö & İlki AA (2022) New Microbiologica 45(4):292-295:
Performance of Sysmex UF-5000 for candiduria screening.
Summary:
This study evaluated the performance of the UF-5000 for the assessment of candidurias to detect or exclude fungal infections by applying the yeast-like cell (YLC) parameter. If compared to Candida culture, the use of a cut-off of 5 YLC/µl resulted in an excellent diagnostic performance with 100 % sensitivity, 95 % specificity a negative predictive value of 100 % and a positive predictive value of 66 %. In conclusion, the performance of the YLC parameter allows the exclusion of candidurias with positive impact on laboratory workflows and antimicrobial stewardship.
Szmulik M et al. (2022) Front Cell Infect Microbiol 12:936854:
A novel approach to screening and managing the urinary tract infections suspected sample in the general human population.
Summary:
This study evaluated the performance of laboratory indicators of UTI on digital imaging (Iris iQ®200 ELITE) and fluorescence flow cytometry (UF-5000) urinalysis instruments, as well as by dip stick testing. For the prediction of urine culture results for UTI, based on WBC and/or BACT, a good diagnostic performance has been observed with a sensitivity of 100 % and a specificity of 83.7 %, resulting in a negative predictive value of 100 % and a s positive predictive value of 75 %. This outcome further highlights the capabilities of the UF-series to rule-out UTIs and to positively improve laboratory workflows in context of UTI.
Chun TTS et al. (2022) Front Cell Infect. Microbiol. 12:936854:
The diagnostic value of rapid urine test platform UF-5000 for suspected urinary tract infection at the emergency department.
Summary:
This study evaluated the diagnostic utility of the UF-5000 for the prediction of UTIs at the emergency department in comparison to dipstick and urine culture. The results of this study highlight the capability of the UF-5000 to predict negative urine culture and to support the laboratory UTI diagnostic pathway, thereby clearly outperforming dip stick assessment with improved predictive values. In addition, the performance of the ‘BACT Info’ flag, especially for Gram negatives with a concordance of 96.2 %, if compared to urine culture might support clinical decisions.
Torres-Sangiao E et al. (2022) Antibiotics 11(5):663:
Direct Urine Resistance Detection Using VITEK 2.
Summary:
This study evaluated the combination of different diagnostic technologies including urine flow cytometry, MALDI-TOF mass spectrometry and automated antibiotic susceptibility testing to reduce the time for reporting UTI-positive samples and proposing a suitable antibiotic susceptibility profile. The aim is to allow fast and precise treatment, thereby minimising the risk for antimicrobial resistance. In this context, the UF-5000 was used to select samples, suspected to be positive for UTI, here BACT counts ≥ 150 cells/mL and the ‘Gram Negative?’ flag were used. After confirmation by MALDI-TOF mass spectrometry, samples positive for E. coli were subjected to AST on VITEK 2. In summary, this study proposes a combination of diagnostic techniques to foster a rapid diagnosis of UTI without the need for long-lasting urine cultures.
Christy P et al. (2022) Int J Nephrol: eCollection 2022:
Comparison of Laboratory Diagnosis of Urinary Tract Infections Based on Leukocyte and Bacterial Parameters Using Standardized Microscopic and Flow Cytometry Methods.
Summary:
This study evaluated a reduction of laboratory turn-around-time for suspected urinary tract infections using the UF-5000 urinary flow cytometry using bacteria and leucocyte counts in comparison to the Shih-Yung microscopy method. In conclusion, urinary flow cytometry showed a very good performance in detecting acquired symptomatic UTIs and a high agreement with culture results.
Kim et al. (2022) Clin Lab 68(12):
Clinical Usefulness of BACT Count and BACT-Info Flag of UF-5000 for Screening for Urinary Tract Infection and Prediction of Gram-Negative Bacteria.
Summary:
In need of a rapid and reliable screening test for (UTI), helping to reduce the turn-around time and to rule out negative results of urine culture, this study assessed the performance of the BACT count and the BACT-Info flag of the UF-5000. The authors recommend the use of a combination of BACT count (685.3/µL) and BACT-Info for UTI assessment, which appeared to be more appropriate for Gram-negative bacteria, and could support the selection of selecting empirical treatment.
Gilboe HM ET AL. (2021) PLoS ONE 16(7): e0254064:
Rapid diagnosis and reduced workload for urinary tract infection using flow cytometry combined with direct antibiotic susceptibility testing.
Summary:
This study evaluated the potential impact of urinary flow cytometry of the UF-5000 on the rapid identification of culture negative and contaminated samples prior to culture plating and on the prediction of positive samples for antibiotic susceptibility testing. Using a cut-off value with bacterial count ≥100,000/mL and WBCs ≥10/μL, urinary flow cytometry predicted 42.1% of samples with non-significant growth and for 52/56 positive samples containing Gram negative bacteria direct Antibiotic Susceptibility Testing (dAST) was identical to routine testing. Overall, there was concordance in 555/560 tested antibiotic combinations. In conclusion, flow cytometry offers improvements in UTI diagnostics by reducing the response times and workloads for negative samples on the day of arrival and by predicting Gram-positive samples for Antibiotic Susceptibility Testing (AST), allowing a same day report of antibiotic susceptibility profiles.
Alenkaer LK et al. (2021) Scand J Clin Lab Invest 81(5):379-384:
Evaluation of the Sysmex UF-5000 fluorescence flow cytometer as a screening platform for ruling
out urinary tract infections in elderly patients presenting at the Emergency Department.
Summary:
This study evaluated the potential of the UF-5000 to rule-out UTI in elderly patients. Using a patient group-specific cut-off value of 108 CBU/L an NPV of 0.92 has been achieved, allowing to rule-out clinically irrelevant cases, potentially saving up to 36% of ordered urine. Due to the quick availability of results, compared to urine culture, the UF-5000 also offers the possibility to better guide the prescription of antibiotics.
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.
Summary:
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.
Ippoliti R et al. (2020) Microbiologyopen 9(3):e987.:
UF-5000 flow cytometer: A new technology to support microbiologists' interpretation of suspected urinary tract infections.
Summary:
This case study aimed to describe the adoption of UF-5000 in context of the microbiology diagnostic pathways to investigate suspected urinary tract infections (UTIs). In conclusion, the UF-5000 can provide information improve the identification of both contamination and colonization, thus reducing inappropriate antibiotic prescriptions. An implementation of this technology thus allows the supply of sustainable treatments by hospitals, especially in context of the reduction of unnecessary use of antibiotics in false-positive results, obtained by reference methods.
Mancini S et al. (2020) J Antimicrob Chemother 75(11):3218-3229:
Evaluation of standardized automated rapid antimicrobial susceptibility testing of Enterobacterales-containing blood cultures: a proof-of-principle study.
Summary:
In this study, the preparation of standardized bacterial inocula for Enterobacterales-containing clinical blood cultures and the automated assessment of data of a rapid antimicrobial susceptibility testing (RAST) is reported, aiming to accelerate antibiotic therapy decisions. The UF-4000 was used to enumerate bacteria to adjust the inocula to 106 cfu/mL. Disc diffusion plates were automatically streaked, incubated for 6, 8 and 18 h and imaged automatically. In conclusion, with the standardized and automated RAST method, consistent AST data from blood cultures containing Enterobacterales can be generated after 6–8 h of incubation and subsequently confirmed by standard reading of the same plate after 18 h.
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.
Summary:
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.
Summary:
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.
Summary:
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.
Summary:
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.
Summary:
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.
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.
Summary:
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.
Summary:
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%).

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.
Summary:
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.

Nephrology

Cho H Y et al. (2022) Ann Lab Med 42(2):160-168:
Diagnostic Characterisation of Urinary Red Blood Cell Distribution Incorporated in UF-5000 for Differentiation of Glomerular and Non-Glomerular Hematuria.
Summary:
This study evaluated the potential of the UC-3500/UF-5000 to screen for Lupus nephritis, a common glomerular disease. The investigation revealed an excellent agreement for the accuracy for assessing the protein-to-creatinine ratio by the UC-3500, if compared to clinical chemistry and good agreement for the detection and quantification of RTECs by the UF-5000, if compared to manual microscopy. RTECs have been shown to be significantly elevated in Lupus nephritis patients. The data highlight a good screening capability for increased protein-to creatinine ratios (specificity of 97.5 % and an a PPV of 96.46 %) or elevated RTEC and protein-to-creatinine ratios (specificity of 97.5 % and an a PPV of 94.03 %). Sensitivity (95.97 %) and NPV (96.24 %) were highest in case only one parameter was positive. In conclusion, the UN-2000 (UC-3500 and UF-5000) can be used to screen for Lupus nephritis.
Chen Y et al. (2022) BMC Nephrology 23:328:
Sysmex UN2000 detection of protein/creatinine ratio and of renal tubular epithelial cells can be used for screening lupus nephritis.
Summary:
This study evaluated the potential of the UC-3500/UF-5000 to screen for Lupus nephritis, a common glomerular disease. The investigation revealed an excellent agreement for the accuracy for assessing the protein-to-creatinine ratio by the UC-3500, if compared to clinical chemistry and good agreement for the detection and quantification of RTECs by the UF-5000, if compared to manual microscopy. RTECs have been shown to be significantly elevated in Lupus nephritis patients. The data highlight a good screening capability for increased protein-to creatinine ratios (specificity of 97.5 % and an a PPV of 96.46 %) or elevated RTEC and protein-to-creatinine ratios (specificity of 97.5 % and an a PPV of 94.03 %). Sensitivity (95.97 %) and NPV (96.24 %) were highest in case only one parameter was positive. In conclusion, the UN-2000 (UC-3500 and UF-5000) can be used to screen for Lupus nephritis.
Mizuno G et al. (2021) Clin Chem Lab Med 59(9):1547–1553:
Evaluation of red blood cell parameters provided by the UF-5000 urine auto-analyzer in patients with glomerulonephritis.
Summary:
This study investigates the potential the UF-5000 for interpretation of morphological information of glomerular RBC by using the UF-5000 RBC-related parameters small RBC (UF-%sRBC) and Lysed-RBC in context of glomerulonephritis in comparison to time-consuming and labour-intensive microscopic examination of haematuria. The data indicate that the UF-%sRBC and Lysed-RBC values differed significantly between glomerulonephritis and non-glomerulonephritis cohorts. Cut-off values have been defined for UF-%sRBC as >56.8% (AUC = 0.649; SE = 94.1%; SP = 38.1%; PPV = 68.3%; NPV = 82.1%) and for Lysed-RBC as >4.6/μL (AUC = 0.708; SE = 82.4%; SP = 56.0%; PPV = 72,6%z, NPV = 69.1%). In conclusion, the applied cut-off values for the UF-5000 RBC parameters UF-%sRBC and Lysed-RBC demonstrated sufficient diagnostic performance to support the diagnosis of glomerulonephritis.

Performance Evaluation / Comparison

Demirel OU et al. (2022) Medicine Science 11(1):367-371:
Comparison of Sysmex UF-5000 flow cytometer and Fuchs-Rosenthal chamber urine sediment analysis.
Summary:
This study evaluated the diagnostic performance of urine sediment analysis performance of the Sysmex UF-5000 flow cytometer with the manual Fuchs-Rosenthal counting chamber. In summary, flow cytometry urinalysis is a promising area compared to the manual reference method. Urinalysis automation reduces TAT, laboratory workloads and workforce and the need for microscopic review.
Yis et al. (2022) Clin Lab 69(3):
Performance Evaluation of Urine Osmolality Measurement on Sysmex UF-5000 and the Effect of Molecules and Particles in Urine.
Summary:
This study evaluated the analytical performance of osmolality measurement of the UF-5000, to examine the effect of different molecules and particles in the urine on the osmolality measurement. Considering the good accessibility of the automated routine complete urine analyser, UF-5000 can be considered to determine whether urine osmolality is within reference or should be measured by methods based on colligative properties. Thus, referral of patients to a clinic that uses the colligative measurement method may be used more effectively.
Yang et al. (2021) BMC Urol 21:24:
A performance comparison of the fully automated urine particle analyzer UF-5000 with UF-1000i and Gram staining in predicting bacterial growth patterns in women with uncomplicated urinary tract infections.
Summary:
This study aims to compare the performance of the new UF-5000 and the UF-1000i and Gram staining for determining bacterial patterns in urine samples. Mid-stream urine samples of women with symptoms suggestive of urinary tract infection were collected for gram staining, urine analysis and urine cultures. Bacterial patterns were classified using the UF-1000i, the UF-5000 and Gram staining. The collected data revealed a sensitivity/specificity of the UF-1000i of 81.8/91.1% for gram-negative rods and 23.5/96.9% for cocci/mixed. The sensitivity/specificity of the UF-5000 was 80.0/88.2% for gram negative rods and 70.0/86.5% for gram-positive cocci. In conclusions, the UF-5000 demonstrated good sensitivity and specificity for Gram-negative bacilli and demonstrated an improved sensitivity for detecting Gram-positive cocci compared with the UF-1000i.
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.
Summary:
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.
Summary:
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.
Summary:
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.
Summary:
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.
Summary:
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

Flagging

Ramiah J L et al. (2023) Afr J Lab Med; 12(1): 2140:
Performance of the automated Sysmex XN-3000 analyser for detecting white blood cell abnormalities in South Africa.
Summary:
A comparison study between WBC flagging and microscopic evaluation in 250 samples (45% haematologic malignancies) showed that 'Blasts?' and 'Abn Lympho?' had a sensitivity of 96.3% and 90% respectively, and a specificity of 84.9% and 96.3%. Low WBC count, chemotherapy, presence of malignancy and/or infection were factors that were associated with discrepant results between flagging and microscopy.
Dedeene L et al. (2022) Int J Lab Hematol; 44(4): e153:
"Smart” WPC reflex testing enables optimal use of the WPC channel in the detection of malignant blood samples using Sysmex XN-9100.
Summary:
In this follow-up publication of Blomme S et al. 2021, the authors have adjusted the criteria for WPC reflex testing. The revised workflow resulted overall in a 40% reduction in the number of WPC reflex tests and a 16% reduction in smear reviewing in a routine set-up.
Blomme S et al. (2021) Int J Lab Hematol; 43(2): 191:
The integration of Sysmex XN-9100’ WPC channel reflex testing in the detection of reactive versus malignant blood samples.
Summary:
In this study the WPC reflex testing showed excellent sensitivity (99%), but low specificity (29%). Using reflex WPC to the WDF channel resulted in a 12% reduction of the smear review rate. The authors suggested workflow for the optimal use of the WPC channel in a routine setting.
Moioli V et al. (2020) Scand J Clin Lab Invest; 80(1): 55:
A specific abnormal scattergram of peripheral blood leukocytes suggestive for the presence of proerythroblast.
Summary:
In this publication two cases of myeloproliferative disorder patients are described. Abnormal cell clusters in the WNR, WDF and WPC scattergrams were present. In oncological patients, this likely indicates the presence of proerythroblasts as a symptom of an erythroid leukaemia and therefore the XN scattergrams were suggested to support a rapid stratification.
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?
Summary:
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.
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.
Summary:
The XN-1000 demonstrated an excellent performance for differentiation between neoplastic and reactive leukocytosis.
Ulset R J et al. (2014) Clin Lab; 60(12): 1961:
“Aged Sample” Software on Automated Routine Hematology Analyzer Enables Differentiation Between Pathological and Non-Pathological WBC Flagging in Aging Samples.
Summary:
'Aged Sample Identifier' software not only detects and labels samples that are ageing or were stored under suboptimal conditions, but also prevents false positive flagging.
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.
Summary:
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.
Summary:
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

Dai Q et al. (2023) Clin Chem Lab Med; 61(7): e131:
Spurious low WBC count in the WNR channel of Sysmex XN-9000 hematology analyzer in a case with leukocyte aggregation.
Summary:
A sample of an 11-year-old girl infected with Cryptococcus neoformans led to discrepancies between WNR and WDF channel results, correctly identified by the XN-9000, due to excessive hyaluronic acid produced from the pathogen.
Ho SF et al. (2023) Diagnostics (Basel); 13(14): 2445:
Exploring Extended White Blood Cell Parameters for the Evaluation of Sepsis among Patients Admitted to Intensive Care Units.
Summary:
The authors observed a specific pattern of CBC parameters (including EIP) and biochemical parameters (CRP, PCT and IL-6) in a small cohort of sepsis (n=30) and non-sepsis (n=23) ICU patients. The combination of certain CBC parameters and EIP was effective in predicting worse outcome. The AUC for the combined parameters (AUC=0.918) was highest compared to the classical markers (SOFA Score = 0.631; CRP = 0.611; PCT= 0.639; IL-6= 0.531).
Vanrenterghem M et al. (2023) Int J Lab Hematol; 45(5): 625:
Carcinocythemia in metastatic breast cancer detected by high fluorescent signals on an automated Sysmex XN-9100 hematological cell counter.
Summary:
This case report describes a patient with suspected microangiopathic haemolytic anaemia (prominence of NRBCs, RET# 0.379 x 10^12/L), 4-5% schistocytes, elevated LDH (1823 U/L)) together with suspicious high fluorescence cells. Smear results and other tests have proven the presence of circulating non-haematological malignant tumour cells, a rare phenomenon called carcinocythaemia.
Bouriche L et al. (2023) Int J Lab Hematol; online ahead of print:
Detection of dysplasia in peripheral blood: Proposal of an algorithm to detect myelodysplastic syndromes and chronic myelomonocytic leukemias on a high-speed technical platform using the Sysmex XN™ analyser.
Summary:
A decision tree utilising the MDS-CBC and mono-dysplasia scores had a 94.4% sensitivity and 91.4% specificity in identifying MDS (n=18) and CMML (n=18) samples within a cohort of 749. Routine implementation of the tree compared to using the recommended cytopenia or monocytosis criteria in over 25,000 samples significantly reduced the smear workload.
Pozdnyakova O et al. (2022) J Clin Pathol; 76(9): 624:
Beyond the routine CBC: machine learning and statistical analyses identify research CBC parameter associations with myelodysplastic syndromes and specific underlying pathogenic variants.
Summary:
A predictive model to identify myelodysplastic syndrome (MDS) samples (n=102) from cytopenic (n=145) or other control samples (n=484) was created using haematology parameters. The model had AUC 0.98, sensitivity 90%, specificity 96% and NPV 99%. Neutrophil parameters and IPF were found to have high predictive value for the model.
Zhu J et al. (2022) BMC Cancer; 22(1): 972:
Machine learning-based improvement of MDS-CBC score brings platelets into the limelight to optimize smear review in the hematology laboratory.
Summary:
A two-step algorithm, triggered by cytopenia, and utilising the MDS-CBC score and IPF, correctly separated myelodysplastic (MDS) samples (n=168) from other non-clonal cytopenic samples (n=357) with a sensitivity of 88.7% and a specificity of 95.8%. The algorithm had a 96.4% classification rate for MDS and 95.8% for the cytopenic controls.
Comar SR et al. (2021) Int J Lab Hematol; 43(6): e280:
Early detection of Candida parapsilosis sepsis in peripheral blood as a result of cytografic changes on the Sysmex XN-3000 hematology analyzer.
Summary:
A case review that describes specific WNR and WDF scattergram patterns of a patient with Candida parapsilopsis sepsis. The authors propose careful overall observation of all information provided by the automated blood count including thorough analysis of scattergrams that might enable early diagnosis of invasive fungal infection.
Shaikh MS et al. (2021) Int J Lab Hematol; 43(3): e141:
Ensuing adequate mixing of blood samples before analysis—A proposed method for verification of satisfactory sample mixing by automated red blood cell count analyzers.
Summary:
The authors report an excellent correlation (r value of 0.99) between manual and automated blood sample mixing with a minimal bias (0.009), proving an exceptional pre-analysis mixing of samples on the XN-1000 analyser.
Debus J et al. (2021) Clin Chem Lab Med; 59(7): e285:
A case of methaemoglobinaemia interference on the WDF channel on Sysmex XN-Series analysers.
Summary:
This report is about a case of acquired methaemoglobinaemia resulting in “WDF abnormal scattergram” flagging on XN-1000 and XE-2100. Interferences were shown to be reduced in the course of therapy. The authors suggested interferences with the reagent reaction in line with existing literature.
Ortiz A et al. (2020) Sysmex J Int; 30(1): 9:
Performance Comparison of Sysmex Hematology Analyzers XN-550 and XN-10.
Summary:
According to the authors 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%). In this study the overall flagging comparison was excellent among the XN-10, the XN-550 and the manual differential.
Urrechaga E et al. (2018) J Clin Pathol; 71(3): 259:
Role of leucocytes cell population data in the early detection of sepsis.
Summary:
Cell population data (CPD) were different between control and sepsis patients in both study (n=719) and validation (n=272) groups. The authors calculated the NEMO score (NE-SFL, MO-X) and classified three statistically significant risk groups (mild (≤3), moderate (4≤NEMO≤5) and high (≥6) risk of sepsis) with an AUC of 0.98 in the study and 0.955 in the validation group.
Boutault R et al. (2018) Br J Haematol; 183(5): 736:
A novel complete blood count-based score to screen for myelodysplastic syndrome in cytopenic patients.
Summary:
The authors suggested an MDS-CBC multiparametric score as a screening tool for MDS patients by combining absolute neutrophil count (ANC), mean corpuscular volume (MCV), and median neutrophil complexity width of dispersion (Ne-WX). The score had a sensitivity of 86% and a specificity of 88% in the leading cohort.
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.
Summary:
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 precision and reportable range were also consistent with specifications by the manufacturer.
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).
Summary:
Using the biomedical validation criteria, 21.3 % of samples triggered a smear review in this study. 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
Summary:
The XP-300 showed very good precision and linearity results in this study, comparable with the XN-3000 analyser.
Seo JY et al. (2015) Int J Lab Hematol; 37(2): 155:
Performance evaluation of the new hematology analyzer Sysmex XN-series.
Summary:
In this study, 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.
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.
Summary:
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.
Takagi Y et al. (2015) Microscopy (Oxf); 64(5): 305:
Comparison of optical data from flow cytometry and microscopy of leukocytes after exposure to specific reagents.
Summary:
Flow cytometry software and electron microscopy methods were used to confirm the positions and fluorescence intensity of WBC populations in the XN-WDF scattergram.
Arneth B et al. (2015) J Clin Lab Anal; 29(3): 175:
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
Summary:
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.
Summary:
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) Feuillets de Biologie VOL LVI N° 317:
Smear microscopy revision: propositions by the GFHC.
Summary:
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.
Summary:
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.
Summary:
In this study 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.

Granulocytes

Fedorov K et al. (2023) Life (Basel); 13(3): 623:
Identifying Neutrophil Extracellular Traps (NETs) in Blood Samples Using Peripheral Smear Autoanalyzers.
Summary:
The authors revealed that the smudge cell category of CellaVision may contain two distinct populations of leukocytes: degenerated lymphocytes and neutrophils exhibiting Neutrophil Extracellular Traps (NETs). This study suggests NET-like smudge cells are not an artifact of smear preparation, are identified in the high SFL area of the WNR scattergram, and express NETs markers identifiable with immunohistochemistry and flow cytometry.
Mantovani EMA et al. (2023) Diagnostics (Basel); 13(10): 1781:
The Potential Role of Neutrophil-Reactive Intensity (NEUT-RI) in the Diagnosis of Sepsis in Critically Ill Patients: A Retrospective Cohort Study.
Summary:
In this study, NEUT-RI showed an AUC of 0.826 in differentiating septic (n=46) from nonseptic (n=50) patients on admission to the ICU. Its negative predictive value (87.4%) was superior to that of PCT (83.9%) and CRP (86.6%) but not significantly influenced by renal failure. The authors concluded that NEUT-RI values, together with clinical signs and currently used inflammatory biomarkers, could be useful in the early diagnosis of sepsis.
Li S et al. (2022) BMC Pulm Med; 22(1): 107:
Neutrophil side fluorescence: a new indicator for predicting the severity of patients with bronchiectasis.
Summary:
Unlike NEUT# and PCT, NEUT-SFL correlates significantly with Bronchiectasis Severity Index score in this study. The cut-off 42.15 FI for NEUT-SFL presents an AUC of 0.813 with a sensitivity of 67.1% and a specificity of 82.1%.
Lemkus L et al. (2022) PLoS ONE; 17(2): e0262938:
The utility of extended differential parameters as a biomarker of bacteremia at a tertiary academic hospital in persons with and without HIV infection in South Africa.
Summary:
In a cohort of bacterial infection patients NE-SFL presented as the best extended differential parameter in identifying bacteraemia in HIV positive patients (AUC = 1) whilst in HIV negative patients IG% performed best (AUC = 0.79). The study revealed a significant correlation to neutrophil CD64 expression which adds scientific validity to NE-SFL as a marker for neutrophil activation.
Cetin N et al. (2022) Pediatr Nephrol; 38(1): 219:
Immature granulocytes as biomarkers of inflammation in children with predialysis chronic kidney disease.
Summary:
A retrospective analysis in 57 children with predialysis chronic kidney disease (CKD) showed that IG%, IG#, WBC#, NEUT#, and NLR were higher compared to healthy children. IG parameters were also higher in stage 4 CDK compared to stage 2 and 3. IG% and IG# could predict the presence of inflammation with an AUC of 0.838 (sensitivity 74.2%) and 0.799 (sensitivity 70.8%) respectively in this cohort.
Lu Q et al. (2022) J Hemat; 15(1): 1:
Evaluation of immature granulocyte parameters in myeloid neoplasms assayed by Sysmex XN hematology analyzer.
Summary:
An analysis of 1,412 blood samples showed that IG% from an XN-Series analyser correlated well with manual microscopy in both myeloid neoplasms (n=388, r=0.83) and non-haematopoietic neoplasms (n=524, r=0.86). IG parameters correctly indicated the presence of immature granulocytes in myeloid neoplasm patients (sensitivity 75% for IG# and 81% for IG%).
Bhansaly P et al. (2022) Indian J Crit Care Med; 26(2): 216:
Evaluation of Immature Granulocyte Count as the Earliest Biomarker for Sepsis.
Summary:
The authors found that IG% and IG# gave an earlier indication of the onset of sepsis than serum procalcitonin and lactate. An increase in IG%/# was found in patients up to 24h before the onset of sepsis according to Sepsis-3 criteria.
Kim H et al. (2021) Int J Lab Hematol; 43(2): e54:
Screening of myelodysplastic syndrome using cell population data obtained from an automatic hematology analyzer.
Summary:
In a study of 63 patients with myelodysplastic syndrome (MDS), RBC, PLT, NE-FSC and NE-SSC exhibited the highest correlation with the disease (AUC from 0.87 to 0.94). The authors propose a combined interpretation of these four parameters for identifying MDS (one out of four cutoff criteria had to be fulfilled).
Güngör A et al. (2021) Postgrad Med;133(7):817:
Utility of biomarkers in predicting complicated appendicitis: can immature granulocyte percentage and C-reactive protein be used?
Summary:
In this study, the best parameters for prediction of complicated appendicitis were found to be IG% (cutoff > 0.35, AUC 0.82, sensitivity 85.4, specificity 61.5) and CRP (cutoff > 33.9, AUC 0.82, sensitivity 75.7, specificity 73.0).
Stiel L et al. (2019) Thromb Res; 183: 153:
First visualization of circulating neutrophil extracellular traps using cell fluorescence during human septic shock-induced disseminated intravascular coagulation.
Summary:
The authors reported direct visualisation of circulating neutrophils extracellular traps (NETs) in patients with septic shock induced disseminated intravascular coagulation (DIC). The previously reported in vivo relevance of NEUT-SFL in NETosis was confirmed.
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
Summary:
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.
Summary:
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 presented as a valuable additional parameter to PCT that improves sepsis identification in this special patient cohort.
Huang Y et al. (2019) J Crit Care; 50: 303:
Immature granulocytes: A novel biomarker of acute respiratory distress syndrome in patients with acute pancreatitis.
Summary:
In patients with acute pancreatitis, immature granulocytes (IG%) could facilitate the identification of patients with a high risk for developing acute respiratory distress syndrome (ARDS). The authors present IG% as a potential indicator of ARDS incidence with predictive power similar to (or greater than) other biomarkers.
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.
Summary:
WBC, neutrophil-to-lymphocyte ratio (NLR), IG# and IG% showed significant changes in patients with acute appendicitis compared to simple appendicitis, while changes in IG# were most prominent.
Delabranche X et al. (2017) J Crit Care; 47(3): 313:
Evidence of Netosis in Septic Shock-Induced Disseminated Intravascular Coagulation.
Summary:
In this study neutrophil fluorescence intensity (NEUT-RI) in blood samples of patients with septic shock exhibited significantly higher values in septic shock-induced disseminated intravascular coagulation (DIC) patients compared to 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.
Summary:
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 using 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.
Summary:
Neutrophil and IG counts correlated with sepsis risk in burn patients. The authors propose the interpretation considering also 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.
Summary:
In this study neutrophil fluorescence (NEUT-RI) above 57.3 FI demonstrated a sensitivity of 90.9 % and a specificity of 80.6 % for 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.
Summary:
NE-SFL and NE-WY parameters showed significantly increased values in sepsis patients compared to the normal control group.
Ha SO et al. (2015) Scand J Clin Lab Invest; 75(1): 36:
Fraction of immature granulocytes reflects severity but not mortality in sepsis.
Summary:
In this study cohort 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 did not correlate with sepsis severity.
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.
Summary:
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 as supportive information in the diagnosis of 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.
Summary:
"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.
Summary:
The study concludes that, automated detection of IG# and IMI# represents a fast, accurate and less labour-intensive method compared to a manual smear review and could improve screening and monitoring for early onset sepsis in neonates.
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.
Summary:
The Granularity Index (GI) was shown to correlate well with 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™.
Summary:
The authors present NEUT-X and the calculated granularity index GI as helpful in the screening 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.
Summary:
In this study the parameters NEUT-X and NEUT-Y were 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.
Summary:
In this study fluorescence flow cytometry was shown to 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.
Summary:
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:
Immature granulocyte measurement using the Sysmex XE-2100. Relationship to infection and sepsis.
Summary:
In this study the automated IG count matched the manual IG count very well. At significantly elevated levels, it is was shown to be 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.
Summary:
The IG count correlated with visual counts thus potentially improving screening and monitoring of various pathological conditions and reducing turnaround time.

Haematopoietic Progenitor Cells (HPC)

Reberšek K et al. (2021) J Clin Apher; 36(6): 870:
Hematopoietic progenitor cell counting can optimize peripheral blood stem cell apheresis process.
Summary:
This study in autologous and allogeneic stem cell donors showed that HPC correlated well with CD34+ cell count, had a very good diagnostic accuracy to identify the apheresis starting point (AUC 0.852), and to predict both an insufficient (AUC 0.884) or sufficient (AUC 0.769) harvest.
Mishra S et al. (2020) Int J Lab Hematol; 43(1): 76:
A study to compare Hematopoietic Progenitor Cell count determined on a next-generation automated cell counter with flow cytometric CD34 count in peripheral blood and the harvested peripheral blood stem cell graft from autologous and allogenic donors.
Summary:
A study on allogeneic and autologous donors showed that HPC had a very good correlation with CD34+ count in peripheral blood and in the final harvest product, and was an efficient predictor for the optimal time of harvesting of 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.
Summary:
The HPC mode was shown to assess the timing of apheresis and thus improve the apheresis workflow by reducing CD34 tests. The parameter demonstrates 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.
Summary:
The authors established two decision trees using 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.
Summary:
In this study, HPC 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.
Summary:
In this study, HPC counts from the XN-Series were more accurate than 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.
Summary:
In this study, automated haematopoietic progenitor cell analysis was presented as 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.
Summary:
This study found that CD34-positive cells fall in the area where stem cells locate in the WPC scattergram. The final yield of collected CD34-positive cells could be predicted from the HPC value in pre-apheresis blood and apheresis products.

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.
Summary:
In this study, 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.
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.
Summary:
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

Lesesve JF et al. (2022) Mediterr J Hematol Infect Dis; 14(1): e2022024:
CAR-T Cells Microscopic and Phenotypic Identification in the Peripheral Blood.
Summary:
The case study of a woman with large B-cell lymphoma treated with CAR-T cells highlights the value of close monitoring of treatment progress after CAR-T cell infusion with WDF channel. WDF scattergrams and peripheral blood smear found atypical lymphocytes that could represent the proliferating CAR-T cells.
Urrechaga E et al. (2021) Scand J Clin Lab Invest; 81(5): 394:
Leukocyte differential and reactive lymphocyte counts from Sysmex XN analyzer in the evaluation of SARS-CoV-2 infection.
Summary:
The prospective observational study aimed to assess the diagnostic performance in distinguishing SARS-CoV-2 infections from other viral or bacterial infections in emergency room (ER) patients presenting with fever. NLR > 3.3 and RE-LYMP >0.6% correctly distinguished 95.6% of SARS-CoV-2 infection patients in the validation group (bacterial and viral infected ER patients).
Rutkowska E et al. (2021) Cells; 10(1): 82:
Usefulness of the New Hematological Parameter: Reactive Lymphocytes RE-LYMP with Flow Cytometry Markers of Inflammation in COVID-19.
Summary:
A study on patients with viral infections showed that RE-LYMP% correlated with the presence of plasmablasts (activated B cells). RE-LYMP also correlated with activation markers on CD4+ and CD8+ T cells in COVID-19 (CD8+ CD45RO+) or other infections (CD38+ and HLA-DR+).
Tantanate C et al. (2018) Lab Med; 49(4): 362:
Performance Evaluation of High Fluorescence Lymphocyte Count: Comparability to Atypical Lymphocyte Count and Clinical Significance.
Summary:
An analysis of 320 blood samples showed that the HLFC parameter from the XN-3000 was higher in samples with infection (n=229), and correlated well with the atypical lymphocytes from the microscopic examination (r=0.865 for counts, and r=0.893 for percentages). HFLC predicted the presence of atypical lymphocytes in the blood smear with an 80% sensitivity in this study.
Henriot I 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.
Summary:
The study investigated new parameters from the Sysmex XN in children with fever. The authors found that the parameter AS-LYMP was significantly higher in children with viral infections. The parameter AS-LYMP (AUC=0.83) had the same discrimination power as procalcitonin (AUC=0.82) to distinguish between bacterial and viral infections in this cohort.
Sale S et al. (2016) J Clin Lab Anal; 30(5): 779:
Detection of Apoptotic Lymphocytes Through Sysmex XN-1000 As a Diagnostic Marker for Mononucleosis Syndrome.
Summary:
The authors propose a new algorithm that integrates the 'Atypical Lympho?' flag, lymphocyte structural parameters (LY-WX, LY-WY, LY-WZ) and presence of events in area of the FCS-SSC and SFL-SSC scattergrams and could aid in the diagnosis of infectious mononucleosis.
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.
Summary:
This study investigated how 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.
Summary:
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.
Summary:
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.
Summary:
This study demonstrates that 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

Kouame H et al. (2023) AHRJ; 6(3): 104:
Monocytosis / Monocytic Dysplasia: Testing a New Diagnostic Tool Using Sysmex XN Analyzer Parameters.
Summary:
A study in 263 patients with monocytosis (≥1x10^9/L and >10%) showed that the mono-dysplasia score (described in Schillinger F et al. 2018) had a sensitivity of 100% and a specificity of 96.4% in identifying samples with monocytic dysplasia.
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.
Summary:
The authors set up a workflow for monocytosis samples including Mono-dysplasia score, smear review and flow cytometry. The proposed 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.
Summary:
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.
Summary:
The study presents a score derived from Sysmex XN parameters that identifies possible CMML samples by excluding reactive monocytes. This reduces the smear review workload.
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.
Summary:
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 in this cohort.

Reference intervals

Bildirici A et al. (2023) Turk J Biochem; 48(4): 388:
Determination of reference intervals of hemogram with advanced clinical parameters by indirect method on Sysmex XN-1000.
Summary:
The CBC+DIFF reference intervals of 68 316 patients aged 18–65 years were determined by indirect method using the non-parametric percentage estimation in Turkish Kastamonu Training and Research Hospital.
Mrosewski I et al. (2023) Clin Chem Lab Med; 61(6): 1116:
Indirectly determined reference intervals for automated white blood cell differentials of pediatric patients in Berlin and Brandenburg.
Summary:
The study presents indirectly determined WBC differential reference intervals (RI) for paediatric patients (0-18 years) in Berlin and Brandenburg area in Germany. No RI for DIFF parameters are available for children < 7 months.
L van Pelt J et al. (2022) Clin Chem Lab Med; 60(6): 907:
Reference intervals for Sysmex XN hematological parameters as assessed in the Dutch Lifelines cohort.
Summary:
The publication provides reference intervals for 105 XN parameters (incl. functional and cell activation parameters) based on data of 15,803 healthy individuals from the Lifelines cohort in the Netherlands. The reference intervals were calculated in accordance to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommended statistical methods.
Becker M et al. (2022) Int J Lab Hematol; 44(4): 729:
Differences between capillary and venous blood counts in children—A data mining approach.
Summary:
In this multicentric study the differences between capillary and venous bloods were investigated in paediatric samples specifying a delta for the CBC parameters dependant on measurement range of the parameter value, time difference in sampling and age of the patient.
Wilson S et al. (2021) Int J Lab Hematol; 43(6): 1394:
Continuous reference curves for common hematology markers in the CALIPER cohort of healthy children and adolescents on the Sysmex XN-3000 system.
Summary:
First study that generated continuous reference intervals (curves) of healthy children and adolescents for 19 haematological XN parameters. Seven parameters required sex-specific reference curves. Continuous reference intervals were found to be accurate estimate of haematological reference ranges over the paediatric age range.
Dockree S et al. (2021) EBioMedicine; 74: 102715:
White blood cells in pregnancy: reference intervals for before and after delivery
Summary:
The study established pregnancy-specific reference intervals for WBC subtypes for use between 8-40 weeks of gestational age and 7-21 days postnatally based on 80,637 blood measurements from 24,318 women from the UK.
Mrosewski I et al. (2021) Clin Chem Lab Med; 60(3): 408:
Indirectly determined hematology reference intervals for pediatric patients in Berlin and Brandenburg.
Summary:
The study presents indirectly determined CBC reference intervals (RI) for paediatric patients (0-18 years) in Berlin and Brandenburg area in Germany.
Song MY et al. (2021) Int J Lab Hematol; 43(6): 1363:
Establishment of pediatric reference intervals for complete blood count parameters in capillary blood in Beijing.
Summary:
The authors established reference intervals for 22 CBC+DIFF parameters from capillary blood in 6799 children aged 3 months to 18 years from Beijing area in China.
Angelo A et al. (2021) BMC Pediatrics; 21: 275:
Umbilical cord blood hematological parameters reference interval for newborns from Addis Ababa, Ethiopia.
Summary:
This pilot study enrolled 139 umbilical cord blood samples from healthy newborns to establish reference values for the KX-21N. For WBC, RBC, and NEUT significant differences were found between caesarean and natural birth.
Bohn MK et al. (2020) Int J Lab Hematol; 42(6): 759:
Complex biological patterns of hematology parameters in childhood necessitating age- and sex-specific reference intervals for evidence-based clinical interpretation.
Summary:
The study establishes a comprehensive paediatric (birth to 21 years) reference intervals for haematology parameters using the XN analyser. The data highlight the dynamic haematological profiles observed in healthy children and adolescents and the need for reference interval stratification by age and sex.
Florin L et al. (2020) Int J Lab Hematol; 42(3): e110:
Establishment of common reference intervals for hematology parameters in adults, measured in a multicenter study on the Sysmex XN-series analyzer.
Summary:
The study provides reference intervals (CBC+DIFF+RET) that could serve as reference values for haematology parameters in adults for laboratories that use the XN-Series analysers.
Zierk J et al. (2019) Clin Chem Lab Med; 57(10): 1595:
Next-generation reference intervals for pediatric hematology.
Summary:
The authors determined percentile charts and z-scores for CBC reference intervals from birth to adulthood. A total of 9,576,910 specimens were gathered from ten German facilities and analysed using predominantly Sysmex X-Class and XN-Class analysers and one Beckman Coulter DxH800 analyser.
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.
Summary:
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.
Ozarda Y et al. (2017) Clin Chem Lab Med; 57(1): 30:
Verification of reference intervals in routine clinical laboratories - practical challenges and recommendations.
Summary:
The opinion paper summarises guidelines and approaches for the verification of reference intervals (RI) in routine clinical laboratories. It gives definitions for common terms, refers to examples and covers challenges such as RI for geriatric and paediatric populations.
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.
Summary:
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.
Summary:
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.
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.
Summary:
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.
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