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      Red and white blood cell morphology characterization and hands-on time analysis by the digital cell imaging analyzer DI-60

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          Abstract

          Background

          The Sysmex DI-60 digital morphology analyzer is a fully automated, cell-locating image analysis system. This study aimed to evaluate the analytical performance of DI-60.

          Methods

          A total of 822 peripheral blood smears were used. The diagnostic performance of DI-60 in terms of red blood cell (RBC) morphology characterization, white blood cell (WBC) differentials, and the total assay time including hands-on time was evaluated.

          Results

          In comparison with manual slide review, DI-60 demonstrated acceptable accuracy in recognizing polychromasia, target cells, and ovalocytes. However, for schistocytes, DI-60 demonstrated low specificity (10.4%) despite the high sensitivity (97.2%). In the precision analysis of RBC morphology characterization, borderline samples harboring specific RBCs showed inconsistencies in the positive results among 20 replicates. Particularly, 6 of 10 samples showed inconsistencies in the precision for schistocytes. For WBC differentials, the overall agreement between pre-classification results and user-verified results was 89.4%. Except for basophils, normal WBCs showed a good correlation between DI-60 (after user verification) and manual counts. The sensitivities in detecting immature granulocytes, blasts, atypical lymphocytes, and normoblasts were 85.9%, 92.0%, 37.5%, and 77.6%, respectively. Although the total assay time of DI-60 was longer than that of manual review, the hands-on time was considerably shorter with a difference of 144.1 s/slide for abnormal samples.

          Conclusion

          DI-60 demonstrated acceptable performance for normal samples. However, for abnormal WBC differentials and RBC morphology characterization, it should be utilized carefully. DI-60 may contribute to an improvement in laboratory efficiency with increased feasibility.

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          Most cited references17

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          The measurement of observer agreement for categorical data.

          This paper presents a general statistical methodology for the analysis of multivariate categorical data arising from observer reliability studies. The procedure essentially involves the construction of functions of the observed proportions which are directed at the extent to which the observers agree among themselves and the construction of test statistics for hypotheses involving these functions. Tests for interobserver bias are presented in terms of first-order marginal homogeneity and measures of interobserver agreement are developed as generalized kappa-type statistics. These procedures are illustrated with a clinical diagnosis example from the epidemiological literature.
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            ICSH recommendations for the standardization of nomenclature and grading of peripheral blood cell morphological features.

            These guidelines provide information on how to reliably and consistently report abnormal red blood cells, white blood cells and platelets using manual microscopy. Grading of abnormal cells, nomenclature and a brief description of the cells are provided. It is important that all countries in the world use consistent reporting of blood cells. An international group of morphology experts have decided on these guidelines using consensus opinion. For some red blood cell abnormalities, it was decided that parameters produced by the automated haematology analyser might be more accurate and less subjective than grading using microscopy or automated image analysis and laboratories might like to investigate this further. A link is provided to show examples of many of the cells discussed in this guideline.
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              ICSH recommendations for identification, diagnostic value, and quantitation of schistocytes.

              Schistocytes are fragments of red blood cells (RBCs) produced by extrinsic mechanical damage within the circulation. The detection of schistocytes is an important morphological clue to the diagnosis of thrombotic microangiopathic anemia (TMA). Reporting criteria between different laboratories, however, are not uniform, owing to variability of shape and nature of fragments, as well as subjectivity and heterogeneity in their morphological assessment. Lack of standardization may lead to inconsistency or misdiagnosis, thereby affecting treatment and clinical outcome. The Schistocyte Working Group of the International Council for Standardization in Haematology (ICSH) has prepared specific recommendations to standardize schistocyte identification, enumeration, and reporting. They deal with the type of smear, method of counting, morphological description based on positive criteria (helmet cells, small, irregular triangular, or crescent-shaped cells, pointed projections, and lack of central pallor). A schistocyte count has a definite clinical value for the diagnosis of TMA in the absence of additional severe red cell shape abnormalities, with a confident threshold value of 1%. Automated counting of RBC fragments is also recommended by the ICSH Working Group as a useful complement to the microscope, according to the high predictive value of negative results, but worthy of further research and with limits in quantitation. © 2011 Blackwell Publishing Ltd.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: Writing – original draft
                Role: Data curationRole: Formal analysis
                Role: Data curationRole: Formal analysisRole: Investigation
                Role: ConceptualizationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                27 April 2022
                2022
                : 17
                : 4
                : e0267638
                Affiliations
                [001] Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
                The Ohio State University, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0003-4751-7384
                https://orcid.org/0000-0002-9229-9665
                Article
                PONE-D-21-29585
                10.1371/journal.pone.0267638
                9045635
                35476704
                26321b6f-0495-43d1-bcc7-92e4e2eaffd2
                © 2022 Kweon et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 13 September 2021
                : 12 April 2022
                Page count
                Figures: 0, Tables: 5, Pages: 13
                Funding
                Funded by: National Research Foundation of Korea
                Award ID: NRF-2021R1A2C2013359
                Award Recipient :
                This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (NRF-2021R1A2C2013359). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
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                Biology and Life Sciences
                Cell Biology
                Cellular Types
                Animal Cells
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                Cell Biology
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