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.
Attention - 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 Please consider that conclusions of articles of this list may be based on low sample numbers or manuscripts that are not peer-reviewed yet (pre-prints).
Hemocytometric characteristics of COVID-19 patients with and without cytokine Storm syndrome on the Sysmex XN-10 hematology analyzer.
A study 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.
Association of Red Blood Cell Distribution Width With Mortality Risk in Hospitalized Adults With SARS-CoV-2 Infection.
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.
Reduced activity of B lymphocytes, recognised by Sysmex XN-2000™ haematology analyser, predicts mortality in patients with coronavirus disease 2019.
The antibody-synthesizing lymphocyte count (AS-LYMP#) together with age, C-reactive protein (CRP) and creatinine level was identified as an independent predictor of in-hospital mortality in COVID-19 patients.
Cell population data: Could a routine hematology analyzer aid in the differential diagnosis of COVID-19.
A letter to the editor that 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.
Complete blood counts and cell population data from Sysmex XN analyser in the detection of SARS-CoV-2 infection.
A letter to the editor that 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.
Evaluation of Routine Blood Tests for Diagnosis of Suspected Coronavirus Disease 2019.
A descriptive diagnostic study that 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%.
Immature platelets in patients hospitalized with Covid-19.
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.
A novel haemocytometric COVID-19 prognostic score developed and validated in an observational
multicentre European hospital-based study.
The intention of the prognostic score is to support the management of
COVID-19 patients. Score values generated within the first three days of hospital admission can 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.
Rapid Screening of COVID-19 Patients by White Blood Cells Scattergrams, a Study on 381 Patients.
A specific pattern of WDF scattergram, the “sandglass shape” pattern of lymphocyte population, was investigated in a cohort of 381 patients and exhibited a sensitivity and specificity of 85.9% and 83.5% for identifying COVID-19 infection, respectively.
Temporal changes in immune blood cell parameters in COVID‐19 infection and recovery from severe infection.
The results show that CBC including extended parameters about activated lymphocytes may be a valuable tool to triage patients with COVID-19. AS-LYMP%L (as a percentage of lymphocytes) yielded the best area under the receiver operating characteristic curve for predicting severe disease.
High-fluorescent lymphocytes are increased in patients with COVID-19.
A retrospective analysis of patients from the epicentre of the COVID-19 outbreak in Wuhan, China showed that while lymphocyte (L) counts were progressively decreased as disease severity increased, high-fluorescent lymphocyte (HFL) count and HFL/L ratio were increased in mild and severe cases compared to healthy controls.
Decreased "WBC*LYM" was observed in SARS-CoV-2-infected patients from a fever clinic in Wuhan.
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.
A summary of the diagnostic and prognostic value of hemocytometry markers in COVID-19 patients.
Evaluation of Prognostic/Diagnostic Value of Hematological Markers in the Detection of Inflammation in Coronavirus Disease: A Review Study.
Single case reports
SARS-CoV-2: A New Aetiology for Atypical Lymphocytes.
COVID-19 and mycoplasma pneumoniae coinfection.
Plasmacytoid lymphocytes in SARS-CoV-2 infection (Covid-19).
Leukoerythroblastic Reaction in a Patient With COVID-19 Infection.
Performance Comparison of Sysmex Hematology Analyzers XN-550 and XN-10.
The XN-550 is highly reliable with functionality comparable to the XN-10. It has shown high correlation coefficients and excellent comparative performance in all CBC, DIFF and RET parameters (except BASO%). The overall flagging comparison was excellent among the XN-10, the XN-550 and the manual differential.
Reference intervals for a complete blood count on an automated haematology analyser Sysmex XN in healthy adults from the southern metropolitan area of Barcelona.
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.
Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.
The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims.
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).
Using the biomedical validation criteria, 21.3 % of samples triggered
a smear review. Modification of four criteria reduced the number of smears from 21.3 % to 15.0 % without loss of clinical value.
Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.
The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser.
Performance evaluation of the new hematology analyzer Sysmex XN-series.
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.
Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers.
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.
Smear microscopy revision: propositions by the GFHC.
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.
Immature platelet fraction based diagnostic predictive scoring model for immune thrombocytopenia
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.
Immature platelet fraction: A useful marker for identifying the cause of thrombocytopenia and predicting platelet recovery
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover IPF is a robust and reliable predictor of platelet recovery in patients with immune thrombocytopenia (ITP) and with malignancies undergoing chemotherapy.
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)
IPF and manual schistocyte counts were able to discriminate pregnancy-associated severe preeclampsia/haemolysis, elevated liver enzymes, and low platelet syndrome (SPE/HELLP) versus thrombotic thrombocytopenic purpura (TTP) patients. The model based on combination of parameters had a good predictive value to discriminate TTP from SPE/HELLP - sensitivity of 92.3%, specificity of 62.5% and AUC 0.827.
Reticulated platelets and immature platelet fraction: Clinical applications and method limitations
Thorough review about reticulated platelets and immature platelet fraction including overview of preanalytical and analytical limitations of methods and clinical applications.
Immature platelet fraction (IPF): A reliable tool to predict peripheral thrombocytopenia.
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.
A CBC algorithm combined with immature platelet fraction is able to identify JAK2 V617F mutation-positive polycythaemia vera patients.
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.
The immature platelet fraction in hypertensive disease during pregnancy
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.
Analytical performance of automated platelet counts and impact on platelet transfusion guidance in patients with acute leukemia.
In this study the performance of impedance platelet counting using PLT-I, LH-750 (PLT-LH), as well as PLT-F was analysed in patients with acute leukaemia. PLT-F demonstrated an excellent performance for the identification of thrombocytopenia and had the lowest rate of undertransfusion. Additionally, the authors found that a high blast count is associated with inaccurate PLT-LH and PLT-I counts.
Prognostic significance of reticulated platelet levels in diabetic patients with stable coronary artery disease.
In stable coronary artery disease patients with diabetes the increased levels of immature platelets (IPF) are associated with a higher risk of major adverse cardiovascular events and inversely correlated with the risk of bleeding.
Immature Platelets As a Predictor of Disease Severity and Mortality in Sepsis and Septic Shock - A Systematic Review
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.
Reticulated Platelets - Changing Focus from Basics to Outcomes.
The authors discussed the role of reticulated platelets in coronary artery disease and in hypo responsiveness to the commonly used anti-platelet drugs. Reticulated platelets may be a useful marker for predicting worse cardiovascular outcome.
Innovative haematological parameters for early diagnosis of sepsis in adult patients admitted in intensive care unit.
The combination of an increased value of IPF# and a decreased value of RET% 24 hours before the onset of sepsis in ICU patients may be considered an early, rapid, inexpensive and widely available measure of sepsis prediction.
Immature platelet fraction (IPF) as a predictive value for thrombopoietic recovery after allogeneic stem cell transplantation.
IPF was able to predict platelet recovery in patients after allogeneic haematopoietic stem cell transplantation in 5 out of 11 patients, while IPF# was able to predict recovery in 7 out of 11 patients. Cut-offs of 5.8 % and 200/µL were used, respectively.
Recurrent Cardiovascular Events Despite Antiplatelet Therapy in a Patient with Polycythemia Vera and Accelerated Platelet Turnover.
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.
Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery.
IPF with optimal cut-off of > 5.4 % is an independent predictor of major adverse cardiovascular events, deep vein thrombosis or pulmonary embolism (modMACE) after non-cardiac surgery and improve risk stratification of surgical patients.
Evaluation of the immature platelet fraction contribute to the differential diagnosis of hereditary, immune and other acquired thrombocytopenias.
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.
Platelet turnover predicts outcome after coronary intervention.
An elevated platelet turnover independently predicts major adverse cardiovascular events after percutaneous coronary intervention. The optimal cut-off value was at IPF = 3.35 %.
The immature platelet fraction: creating neonatal reference intervals and using these to categorize neonatal thrombocytopenias.
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.
Abnormal leukocyte scattergrams and immature platelet fraction on Sysmex XN-9000 analyzer: a new diagnostic tool for altered megakaryopoiesis?
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.
Assessment of platelet activation and immature platelet fraction as predictors of platelet engraftment after hematopoietic stem cell transplantation.
The study showed that IPF (XE-2100) can be used to assess thrombopoietic recovery after stem cell transplantation. Patients in the cord blood group had a higher IPF than the peripheral blood group on day 56 and day 97 post-transplantation.
Thrombocytopenia and platelet transfusion in the neonate.
The review summarises the pathophysiology and current management (including platelet transfusion thresholds) of neonatal thrombocytopenia. Novel index score for bleeding risk in thrombocytopenic neonates is proposed (including IPF#).
Immature platelet fraction in hypertensive pregnancy.
IPF% measured on the XE-5000 in pregnant women suffering hypertensive disorders was higher than in control group (3.8, 2.4–5.1 %; 8.6, 5.8–10.6 %; 7.3, 4.2–10.2 %; p < 0.001 for control group, preeclampsia syndrome and non-proteinuric hypertension, resp.).
Absolute immature platelet count dynamics in diagnosing and monitoring the clinical course of thrombotic thrombocytopenic purpura.
The absolute IPF (from XE-5000) is useful to diagnose and to monitor the clinical course of therapeutic plasma exchange in TTP patients. Routine analysis of the absolute IPF is recommended for diagnosis and to better assess the need for adjustment of treatment.
Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders.
IPF% from the XN-1000 and RP% obtained by immuno flow cytometry had a comparable diagnostic value for the distinction between controls, immune thrombocytopenia (due to platelet destruction) and aplastic thrombocytopenia.
Immature platelet fraction values predict recovery of platelet counts following liver transplantation.
IPF% value predict recovery of PLT counts after liver transplantation. PLT counts reached the pre-transplant levels at 3-4 days after the IPF% peak value.
Immature platelet fraction measurement is influenced by platelet size and is a useful parameter for discrimination of macrothrombocytopenia.
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 %).
Evaluation of the immature platelet fraction in the diagnosis and prognosis of childhood immune thrombocytopenia.
IPF% obtained from the XE-2100 was increased in immune thrombo-cytopenia patients but not in patients with haematological malignancies. Therefore, IPF% may be used to evaluate the thrombopoietic state of the bone marrow.
Assessment of immature platelet fraction and immature reticulocyte fraction as predictors of engraftment after hematopoietic stem cell transplantation.
Both IRF% and IPF% can be used to predict neutrophil and platelet recovery, respectively. Work was done on XE-5000.
Beyond the platelet count: immature platelet fraction and thromboelastometry correlate with bleeding in patients with immune thrombocytopenia.
The IPF# demonstrated stronger correlation with acute bleeding score than platelet counts. The strongest correlation was seen for paediatric patients with platelet counts <30 x109/L. High IPF# was associated with low bleeding score.
Reference interval for immature platelet fraction on Sysmex XN hematology analyzer: a comparison study with Sysmex XE-2100.
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.
Association of Immature Platelets With Adverse Cardiovascular Outcomes.
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).
Evaluation of the IPF as an indicator of PLT recovery in dengue patients.
IPF can be used to monitor the thrombocytopenia in patients with dengue fever. Furthermore, it can predict the recovery of PLT and so avoid unnecessary blood transfusions.
Immature platelet fraction analysis demonstrates a difference in thrombopoiesis between normotensive and preeclamptic pregnancies.
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.
Immature platelet fraction (IPF) measured on the Sysmex XN haemocytometer predicts thrombopoietic recovery after autologous stem cell transplantation.
"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."
Measurement of the absolute immature platelet number reflects marrow production and is not impacted by platelet transfusion.
Absolute IPF is a good parameter to assess the megakaryocytic activity of the bone marrow in transfusion-dependent thrombocytopenic patients.
Low immature platelet fraction suggests decreased megakaryopoiesis in neonates with sepsis or necrotizing enterocolitis.
Low absolute IPF values during the course of neonatal sepsis/necrotising enterocolitis suggest suppression of megakaryopoietic activity.
Establishment of reference interval for immature platelet fraction.
The study provides reference intervals for PLT, IPF% and absolute IPF from more than 2,000 healthy individuals and from umbilical cord blood, according to the CLSI guideline. These results could be used as fundamental data for clinical use as well as future researches.
Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study.
Reticulated (immature) platelets may be independent predictors of cardiovascular death and may potentially be useful in improving risk stratification for acute coronary syndrome patients.
The immature platelet fraction: where is it now?
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.
The immature platelet fraction: an assessment of its application to a routine clinical laboratory.
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.
In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation.
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%.
Application of reticulated platelets to transfusion management during autologous stem cell transplantation.
Using IPF-rich platelet transfusions reduces the number of transfusions and bleedings after stem cell transplantation in paediatric patients.
Mechanism of thrombocytopenia in chronic hepatitis C as evaluated by the immature platelet fraction.
IPF% can support the differentiation between platelet destruction and bone marrow failure in hepatitis C patients.
Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients.
The immaturity fractions IPF and IRF offer an easy and early evaluation method of post-transplantational recovery of the bone marrow
Platelet production and platelet destruction: assessing mechanisms of treatment effect in immune thrombocytopenia.
The absolute immature platelet count (IPF#) can be used to assess the effect of different treatments of immune thrombocytopenia and could in such cases be more useful than IPF%.
Immature Platelet Count: A Simple Parameter for Distinguishing Thrombocytopenia in pediatric acute lymphocytic leukemia from immune thrombocytopenia.
"Both IPF% and IPF# parameters should become a standard for evaluating the respective pathophysiology’s underlying both congenital and acquired thrombocytopenias."
High platelet turnover and reactivity in renal transplant recipients patients.
Renal transplant recipients showed significantly higher values of reticulated platelets (IPF) than healthy control subjects, especially in those not on aspirin treatment.
An elevated IPF% could be an additional hint for a mechanism involved in the increased cardiovascular risk profile of those patients.
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.
An IPF% of above 10% is a useful marker for predicting the timing of platelet recovery after chemotherapy and haematopoietic stem cell transplantation and has the potential to facilitate optimal platelet transfusion.
Immature platelet fraction as novel laboratory parameter predicting the course of neonatal thrombocytopenia.
"If the IPF is high, thrombocytopenic neonates are likely to recover on their own."
Prognostic value of immature platelet fraction and plasma thrombopoietin in disseminated intravascular coagulation
The authors demonstrated that the IPF is an excellent marker for distinguishing hyperdestructive/consumptive from hypoproductive thrombocytopenia. Moreover IPF is a robust and reliable predictor of platelet recovery in patients with immune thrombocytopenia (ITP) and with malignancies undergoing chemotherapy.
Immature platelet fraction for prediction of platelet engraftment after allogeneic stem cell transplantation.
IPF counting can provide an accessible marker of engraftment after transplantation, especially of thrombopoietic activity.
A simple technique to determine thrombopoiesis level using immature platelet fraction (IPF).
The results show that the IPF reflects the pathology of thrombo¬cytopenic disorders (i.e. consumptive versus productive). Measurement of the IPF is useful for the differential diagnosis and analysis of platelet kinetics and significantly more so than the mean platelet volume (MPV).
Immature platelet fraction measurement: a future guide to platelet transfusion requirement after haematopoietic stem cell transplantation.
The automated IPF is a useful parameter in the clinical evaluation of the thrombocytopenic patient and has the potential to allow optimal transfusion of platelet concentrates.
A clinical evaluation of high fluorescent platelet fraction percentage in thrombocytopenia.
The IPF (here named HFPF for ‘high fluorescence platelet fraction’) was predictive in the evaluation of thrombocytopenia. An elevated IPF is found with increased platelet production, particularly associated with platelet destruction, and in disorders associated with decreased platelet production the IPF is normal.
Assessment of an immature platelet fraction (IPF) in peripheral thrombocytopenia.
Automated IPF% measurement should become a standard parameter in evaluating the thrombocytopenic patient.
Performance Evaluation of Automated Impedance and Optical Fluorescence Platelet Counts Compared With International Reference Method in Patients With Thalassemia.
PLT-I, PLT-O and PLT-F in thalassaemia patients were compared with CD41/CD61 immune flow cytometry. PLT-O and PLT-F had better correlations with flow cytometry than PLT-I. PLT-F had a better specificity for detection of PTL counts below 100,000/µL.
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.
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.
Accuracy of a New Platelet Count System (PLT-F) Depends on the Staining Property of Its Reagents.
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.
Evaluating platelet counting on a new automated analyser.
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.
Performance Evaluation of Platelet Counting by Novel Fluorescent Dye Staining in the XN-Series Automated Hematology Analyzers.
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.
New fluorescent method (PLT-F) on Sysmex XN2000 hematology analyzer achieved higher accuracy
in low platelet counting.
The PLT-F method of the XN-2000 demonstrated excellent reproducibility in samples with low platelet counts. Therefore, it is recommended for making decisions about platelet transfusions.
Performance evaluation of the Sysmex haematology XN modular system.
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.
The most accurate platelet count on the Sysmex XE-2100. Optical or impedance?
The accuracy of the XE-2100 platelet counting on chemotherapy samples with low counts is excellent when the switching algorithm is used. The optical count is not always the most accurate and the overriding of the algorithm is not good practice.
Semiquantitative, fully automated urine test strip analysis.
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.
Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase.
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.
Sensitive albuminuria analysis using dye-binding based test strips.
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.
Investigation of Atyp.C using UF-5000 flow cytometer in patients with a suspected diagnosis of urothelial carcinoma: a single-center study.
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.
“Atypical Cell” Parameter in Automated Urine Analysis for the Diagnosis of Bladder Cancer: A Retrospective Pilot Study.
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.
Atypical cells in Sysmex UN automated urine particle analyzer: a case report and pitfalls for future studies.
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.
Preliminary evaluation of UF-5000 Body Fluid Mode for automated cerebrospinal fluid cell counting.
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
Progress in Automated Urinalysis.
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.
Cost analysis of the automated examination of urine with the Sysmex UN-SeriesTM in a Spanish population.
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.
Renal Tubular Epithelial Cells Add Value in the Diagnosis of Upper Urinary Tract Pathology.
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.
Evaluation of the AID AmpC line probe assay for molecular detection of AmpC Enterobacterales.
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.
Compatibility of the Results of an Automated Urine Analyzer with Urine Culture.
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.
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.
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.
Rapid Screening of Urinary Tract Infection and Discrimination of Gram-Positive and Gram-Negative Bacteria by Automated Flow Cytometric Analysis Using Sysmex UF-5000.
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.
Selection of Unnecessary Urine Culture Specimens Using Sysmex UF-5000 Urine Flow Cytometer.
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.
The importance of diagnosis gram-negative/gram positive bacteria in urine in the pre-culture screening of urine tract infections in the microbiology laboratory fluorescence flow cytometry on the UF-4000 urine analyser (Sysmex) for early initiation of targeted antibiotic therapy
This study investigated sensitivity and specificity of the UF-4000 for the discrimination between Gram-positive and Gram-negative bacteria in pre-culture screenings for urinary tract infections in a microbiology laboratory using fluorescence flow cytometry. Gram-positive and Gram-negative bacteria have been detected in urine, with sensitivities 78 % and 89 % and specificities of 96 % and 89 %, respectively. In conclusion, UF-4000 demonstrated a high potential in pre-culture screenings of urinary infections in a microbiology laboratory and is of benefit to the patient for its role in early initiation of antibiotic therapy, targeting Gram-positive or Gram-negative bacteria.
Evaluation of automated urine particle analyzer, UF-5000, as a screening tool to identify Gram stainability of urinal pathogens.
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.
Cut-off values to rule out urinary tract infection should be gender-specific.
This study investigated the potential of urine flow cytometry of the UF-5000 to rule-out urinary tract infections and to reduce the load of urine culture samples. Applying cut-off value of >200 bacteria/μl, a sensitivity of 93.0%, a specificity of 63.5% and an NPV of 96.2% has been obtained. As a result, the culturing of 49% of all samples could be avoided. In addition, the data was retrospectively analyzed to determine if the introduction of gender-specific cut-off values could improve screening results. The obtained receiver operator curves are indeed significantly different when gender specific cut-offs were used. When an NPV of 95% is considered acceptable the unisex cut-off value of >200bacteria/μl can be used for women (NPV 94.9%), but the cut-off value for men could be raised to >400bacteria/μl without diminishing the NPV (NPV 95.0%).
Performance Evaluation / Comparison
Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy.
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.
Performance of automated urine analyzers using flow cytometric and digital image-based technology in routine urinalysis.
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.
Comparison of five automated urine sediment analyzers with manual microscopy for accurate identification of urine sediment.
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.
Evaluation of the analytical performances of Cobas 6500 and Sysmex UN-Series automated urinalysis systems with manual microscopic particle counting.
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.
Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber.
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.