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      Evaluation of the Sysmex XQ‐320 three‐part differential haematology analyser and its flagging capabilities

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          Abstract

          Background

          Three‐part differential (3PD) haematology analysers offer a quick, easy‐to‐use and economical way to acquire important information about a patient's physiology. In this study, we evaluated a new 3PD analyser, the Sysmex XQ‐320, investigated its comparability with its predecessor (Sysmex XP‐300) and the five‐part differential analyser Sysmex XN‐9000, and explored its flagging potential.

          Methods

          Analytical performance studies were conducted for repeatability, within‐laboratory precision, between‐day precision, carry‐over and linearity with fresh blood and QC material. Method comparison was performed in 493 samples comparing XQ‐320 with XP‐300, using the XN‐9000 as the gold standard.

          Results

          The XQ‐320 excelled manufacturer's specifications in the analytical performance studies, except for MXD in within‐laboratory and between‐day precisions using the QC material level 1. The XQ‐320 showed correlation values greater than 0.94 with XN‐9000 for the majority of the 20 reportable parameters (MXD# 0.891, MXD% 0.898 and MCHC 0.849). Improvements over the XP‐300 were observed in WBC in the leucocytopenic range (bias −0.038 vs. −0.097) and PLT (bias 2.568 vs. −7.877, intercept 3.880 vs. −8.845). Concordance between XQ‐320 and XP‐300 was 91.9% for the WBC histogram abnormal distribution flag and 95.3% for the PLT flag. Patterns of increased neutrophils and decreased mixed cells on the XQ‐320 were observed in samples that raised a flag on XN‐9000.

          Conclusion

          The XQ‐320 showed excellent analytical performance, and very good to excellent correlation with XN‐9000 with improvements over XP‐300. Flagging combined with parameter patterns identified additional suspected abnormal samples, thus making the XQ‐320 an excellent solution for laboratories utilising 3PD analysers.

          Abstract

          The Sysmex XQ‐320 three‐part differential analyser showed very good to excellent correlation with the Sysmex XN‐9000 in all reportable parameters, with notable improvements over its predecessor XP‐300 in key areas, such as measuring WBC in the leucocytopenic range, and delivering precise PLT values. The XQ‐320 flagging system provides all relevant information at a glance.

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          Most cited references9

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          ICSH guidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting.

          This revision is intended to update the 1994 ICSH guidelines. It is based on those guidelines but is updated to include new methods, such as digital image analysis for blood cells, a flow cytometric method intended to replace the reference manual 400 cell differential, and numerous new cell indices not identified morphologically are introduced. Haematology analysers are becoming increasingly complex and with technological advancements in instrumentation with more and more quantitative parameters are being reported in the complete blood count. It is imperative therefore that before an instrument is used for testing patient samples, it must undergo an evaluation by an organization or laboratory independent of the manufacturer. The evaluation should demonstrate the performance, advantages and limitations of instruments and methods. These evaluations may be performed by an accredited haematology laboratory where the results are published in a peer-reviewed journal and compared with the validations performed by the manufacturer. A less extensive validation/transference of the equipment or method should be performed by the local laboratory on instruments prior to reporting of results.
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            White Blood Cell Counts

            Modern hematology laboratories use automated hematology analyzers to perform cell counts. These instruments provide accurate, precise, low-cost differential counts with fast turnaround times. Technologies commonly used include electrical impedance, radiofrequency conductivity, laser light scattering, and cytochemistry. This article reviews the principles of these methodologies and possible sources of error, provides guidance for selecting flagging criteria, and discusses novel, clinically relevant white blood cell parameters provided by new instruments, including immature granulocyte count and granularity index.
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              Enhancing the Clinical Value of Medical Laboratory Testing.

              The value of medical laboratory testing is often directed to the cost of testing however the clinical benefits of these tests are at least as important. Laboratory testing has an acknowledged widespread role in clinical decision making, and therefore a role in determining clinical outcome. Consequently, the value of laboratory testing should be considered in its role in affecting beneficial actions and outcomes. This includes both the requesting phase of choosing tests which will influence clinical decision making as well as the reporting phase in a way that guides clinical decisions and actions. Clinical decision support systems and software can enhance the value of medical laboratory testing if they are directed toward facilitating those clinical decisions where there is either evidence, or agreed consensus, addressing patient outcomes.
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                Author and article information

                Contributors
                mintzas.konstantinos@sysmex-europe.com
                Journal
                J Clin Lab Anal
                J Clin Lab Anal
                10.1002/(ISSN)1098-2825
                JCLA
                Journal of Clinical Laboratory Analysis
                John Wiley and Sons Inc. (Hoboken )
                0887-8013
                1098-2825
                23 February 2024
                February 2024
                : 38
                : 4 ( doiID: 10.1002/jcla.v38.4 )
                : e25017
                Affiliations
                [ 1 ] General Haematology Laboratory Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Switzerland
                [ 2 ] Sysmex Europe SE Norderstedt Germany
                Author notes
                [*] [* ] Correspondence

                Konstantinos Mintzas, Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt, Germany.

                Email: mintzas.konstantinos@ 123456sysmex-europe.com

                Author information
                https://orcid.org/0009-0005-5217-4592
                Article
                JCLA25017 JCLA-23-1126.R2
                10.1002/jcla.25017
                10943257
                38396348
                807bce85-3626-4ea5-9187-cd01f0539dff
                © 2024 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 29 January 2024
                : 20 November 2023
                : 04 February 2024
                Page count
                Figures: 5, Tables: 5, Pages: 12, Words: 5326
                Funding
                Funded by: Sysmex Swiss AG
                Categories
                Research Article
                Research Articles
                Custom metadata
                2.0
                February 2024
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.9 mode:remove_FC converted:16.03.2024

                Clinical chemistry
                analytical performance,correlation,flagging,haematology analyser,three‐part differential

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