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Comparison between optical microscopy and the Sysmex XN-3000 for schistocyte determination in patients suspected of having schistocytosis.

ABSTRACT: Background and aims:Diagnosis of thrombotic microangiopathy (TMA) relies on microscopic schistocyte determination by an experienced microscopist. In addition, schistocytes can be found in non-TMA-related disorders such as thalassaemia. We aimed to compare the accuracy of the automated haematology analyser Sysmex XN-3000 for schistocyte detection, to that of the microscopy approach, in patients suspected of having schistocytosis. Methods:Consecutive blood samples were collected between April 2016 and March 2017 at Siriraj Hospital, Mahidol University, Bangkok, Thailand. Specimens were collected from adults with suspected TMA or with thalassaemia trait and/or disease. All blood samples were examined by both microscopy and the analyser. Samples were considered to be positive for schistocytes (ie, schistocytosis) if they had a schistocyte count ?1% by microscopy. The analyser's ability to determine schistocytosis was assessed by receiver operating characteristic (ROC) curve. Sensitivity, specificity, positive (PPV), and negative predictive value (NPV) of an appropriate cut-off point were calculated, with manual microscopy as the standard. Quantitative agreement in schistocyte counts between the two approaches was assessed using 95% limits of agreement, Bland-Altman plots, intraclass correlation coefficient, and concordance correlation coefficient. Results:Ninety-seven blood samples (62 suspected TMA and 35 thalassaemia) were collected. ROC curve analysis of the analyser for determining schistocytosis showed an area under the curve of 0.803 (95% confidence interval, 0.689-0.917, P < 0.001). A cut-off point of 0.6% yielded 86.1% sensitivity, 77.8% specificity, 94.4% PPV, and 56.0% NPV. The automated schistocyte count did not quantitatively agree with schistocyte counts by microscopy, neither in all blood specimens (mean of difference: -1.09; 95% limits of agreement, -11.9 to 9.7) nor in the subgroups (TMA, -0.88; 95% limits of agreement, -6.60 to 4.84; thalassaemia, -2.4; 95% limits of agreement, -14.10 to 9.30). The differences in the estimation of fragmented red blood cells between the methods tended to increase at higher schistocyte counts. Conclusion:Sysmex XN-3000 can be used for qualitative measurement of schistocytosis, but should not be used as a quantitative tool for schistocyte counting. Improvements are needed before this analyser's schistocyte detection feature can be recommended for use in clinical practice.

SUBMITTER: Hantaweepant C

PROVIDER: S-EPMC7060895 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Comparison between optical microscopy and the Sysmex XN-3000 for schistocyte determination in patients suspected of having schistocytosis.

Hantaweepant Chattree C Sasijareonrat Natthaporn N Chutvanichkul Boonyanuch B Karaketklang Khemajira K Chinthammitr Yingyong Y

Health science reports 20191129 1

<h4>Background and aims</h4>Diagnosis of thrombotic microangiopathy (TMA) relies on microscopic schistocyte determination by an experienced microscopist. In addition, schistocytes can be found in non-TMA-related disorders such as thalassaemia. We aimed to compare the accuracy of the automated haematology analyser Sysmex XN-3000 for schistocyte detection, to that of the microscopy approach, in patients suspected of having schistocytosis.<h4>Methods</h4>Consecutive blood samples were collected bet ...[more]

PMID: 32166186

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Project description:BackgroundThe Sysmex XN-V is derived from the new Sysmex XN series of human hematology analyzers. The main changes from the previously validated XT-2000iV analyzer include an optic-fluorescent analysis for platelets and nucleated RBC count.ObjectiveWe aimed to validate the Sysmex XN-V for canine blood according to American College for Veterinary Clinical Pathology and International Council for Standardization in Hematology recommendations.Materials and methodsCanine EDTA blood specimens and quality control material were analyzed on the Sysmex XN-V to evaluate imprecision, bias, linearity, a comparison with the XT-2000iV analyzer, interference effects, carry-over, and stability. We also verified previously established Sysmex XT-2000iV reference intervals (RIs).ResultsImprecision and bias were low (<5%) for most variables. Observed total error was lower than allowable total error for most measured variables except lymphocytes and monocytes. Visually determined linearity was excellent for all variables, except for lymphocytes. The correlation between the XN-V and XT-2000iV analyzers was high (>0.93) for all variables except MCHC and reticulocyte indices. Correlations between the Sysmex XN-V and manual differential counts were good for neutrophils and eosinophils, acceptable for lymphocytes, and fair for monocytes. Hemolysis, lipemia, and to a lesser extent icterus, had significant effects on measured hemoglobin concentration and associated variables. Carry-over was not visually observed for any variable. Changes in the Sysmex XN-V measurements after storage at 4℃ and 24℃ were similar to those described for the Sysmex XT-2000iV analyzer. The previously established Sysmex XT-2000iV RIs can be used to interpret results from the Sysmex XN-V analyzer for most variables except red blood cell distribution width and mean platelet volume.ConclusionsThe performance of the Sysmex XN-V analyzer was excellent and compared favorably with the Sysmex XT-2000iV analyzer.

Project description:BackgroundEarly and accurate diagnosis of malaria is a critical aspect of efforts to control the disease, and several diagnostic tools are available. Microscopic assessment of a peripheral blood smear enables direct visualization of parasites in infected red blood cells and is the clinical diagnostic gold standard. However, it is subjective and requires a high level of skill. Numerous indirect detection methods are in use, but are not ideal since surrogate markers of infection are measured. This study describes the first clinical performance evaluation of the automated Sysmex XN-30 analyser, which utilizes fluorescence flow cytometry to directly detect and quantitate parasite-infected red blood cells.ResultsResidual EDTA blood samples from suspected malaria cases referred for routine diagnosis were analysed on the XN-30. Parasitaemia was reported as a percentage, as well as absolute numbers of infected red blood cells, and scattergrams provided a visual image of the parasitized red blood cell clusters. The results reported by the XN-30 correlated with microscopy and the analyser demonstrated 100% sensitivity and specificity. Measurements were reproducible and storage of samples at room temperature did not affect the parameters. Several Plasmodium species were detected, including Plasmodium falciparum, Plasmodium vivax and Plasmodium ovale. The XN-30 also identified the transmissible gametocytes as a separate cluster on the scattergrams. Abnormal red blood cell indices (low haemoglobin and raised reticulocyte counts), haemoglobinopathies and thrombocytopenia did not interfere with the detection of parasites. The XN-30 also generated a concurrent full blood count for each sample.ConclusionsThe novel technology of the Sysmex XN-30 provides a robust, rapid, automated and accurate platform for diagnosing malaria in a clinical setting. The objective enumeration of red blood cells infected with Plasmodium species makes it suitable for global use and allows monitoring of the parasite load once therapy has been initiated, thereby providing an early marker of drug resistance. The automated generation of a full blood count for each sample provides an opportunity for detecting unsuspected cases. Asymptomatic carriers can also be identified, which will be useful in blood transfusion centres, and will enable treatment of these individuals to prevent the spread of the disease.

Dataset Information

Comparison between optical microscopy and the Sysmex XN-3000 for schistocyte determination in patients suspected of having schistocytosis.

Publications

Comparison between optical microscopy and the Sysmex XN-3000 for schistocyte determination in patients suspected of having schistocytosis.

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