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      Performance evaluation of the new Sysmex XR-Series haematology analyser

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          Abstract

          Background

          The new XR-Series haematology analyser from Sysmex provides increased throughput and automation, along with a new reagent in WDF channel for optimised WBC differential.

          Methods

          An analytical performance study for the XR analyser was conducted to evaluate the WDF channel parameters in comparison to the instrument specifications. Additionally, 7460 samples were measured on XR and XN analysers to compare selected parameters and flags, and 930 randomly selected samples were further evaluated with microscopy.

          Results

          All investigated aspects of the analytical performance study for the XR fell within the manufacturer specifications. The correlation coefficients between the two systems for the parameters tested were greater than 0.983 for the main CBC and DIFF parameters, greater than 0.909 for the Extended Inflammation Parameters, and greater than 0.932 for the parameters used in the workflow rulesets of the Extended IPU. Similarly high sensitivities for the detection of abnormal cells were observed for the ‘Blasts/Abn Lympho?’ flag (XN: 100%, XR: 99.0%) and WPC abnormal flags (‘Blasts?’ or ‘Abn Lympho?‘) (XN: 97.0%, XR: 96.0%). XN with WPC channel had a 26% reduction of false positive smears compared to XR with 22% reduction, a statistically non-significant difference.

          Conclusion

          The XR analyser had very good analytical performance, and highly comparable results to the predecessor XN analyser in all investigated parameters, flags and workflow aspects.

          Highlights

          • •

            New XR-Series haematology analyser provides increased throughput, automation, and optimised WBC differential.

          • •

            The analytical performance, method comparison and flagging studies for XR-Series versus XN-Series analyser were conducted.

          • •

            Correlation coefficients between the two systems for the parameters tested were excellent (r > 0.915).

          • •

            High sensitivities for the detection of abnormal cells were observed for the ‘Blasts/Abn Lympho?’ and WPC abnormal flags..

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          Most cited references27

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          Performance evaluation of the Sysmex haematology XN modular system.

          Carol Briggs, Ian Longair, Punamar Kumar … (2012)
          The Sysmex XN haematology instrument performs automatic reflex testing, depending on sample results. A nucleated red blood cell (NRBC) count is provided on all samples. The instrument has a smaller footprint (34%) than previous Sysmex XE analysers. An evaluation comparing all results to the Sysmex XE-2100 and manual microscopic differential and morphology (n=390) was performed followed by a workflow study of 1000 samples to compare speed of operation and number of blood films reviews required from both systems. The new features on the instrument are: (1) white cell and NRBC channel, all samples include the NRBC count; (2) white cell precursor channel: false positive flags for blasts, abnormal lymphocytes and atypical lymphocytes are reduced significantly without a statistical increase of false negatives; (3) low white cell count mode: suggested setting of <0.5×10(9)/l. An extended count is more precise and provides an accurate differential. Fluorescent platelet count is performed in a dedicated channel. If the red cell or platelet size histograms are abnormal or if the platelet count is low, then a fluorescent platelet count is automatically performed. Good correlation with the XE-2100 and manual differential was found and the improved results compared to the reference flow cytometric analysis for platelet counts, especially below 30×10(9)/l (XE-2100, R(2)=0.500; XN, R(2)=0.875). The XN showed reduced sample turnaround time of 10% and reduced number of blood films for examination, 49% less than the XE-2100 without loss of sensitivity with more precise and accurate results on low cell counts.
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            A novel haemocytometric COVID-19 prognostic score developed and validated in an observational multicentre European hospital-based study

            Joachim Linssen, Anthony A.M Ermens, Marvin A.H. Berrevoets … (2020)
            COVID-19 induces haemocytometric changes. Complete blood count changes, including new cell activation parameters, from 982 confirmed COVID-19 adult patients from 11 European hospitals were retrospectively analysed for distinctive patterns based on age, gender, clinical severity, symptom duration, and hospital days. The observed haemocytometric patterns formed the basis to develop a multi-haemocytometric-parameter prognostic score to predict, during the first three days after presentation, which patients will recover without ventilation or deteriorate within a two-week timeframe, needing intensive care or with fatal outcome. The prognostic score, with ROC curve AUC at baseline of 0.753 (95% CI 0.723–0.781) increasing to 0.875 (95% CI 0.806–0.926) on day 3, was superior to any individual parameter at distinguishing between clinical severity. Findings were confirmed in a validation cohort. Aim is that the score and haemocytometry results are simultaneously provided by analyser software, enabling wide applicability of the score as haemocytometry is commonly requested in COVID-19 patients.
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              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.

              Mathias Bruegel, Dorothea Nagel, Manuela Funk … (2015)
              Various types of automated hematology analyzers are used in clinical laboratories. Here, we performed a side-by-side comparison of five current top of the range routine hematology analyzers in the setting of a university hospital central laboratory.
              Article 0 comments Cited 20 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ondrej Valina
                Journal
                Journal ID (nlm-ta): Pract Lab Med
                Journal ID (iso-abbrev): Pract Lab Med
                Title: Practical Laboratory Medicine
                Publisher: Elsevier
                ISSN (Electronic): 2352-5517
                Publication date PMC-release: 15 February 2024
                Publication date Collection: March 2024
                Publication date (Electronic): 15 February 2024
                Volume: 39
                Electronic Location Identifier: e00370
                Affiliations
                [a ]Sysmex R&D Centre Europe, Norderstedt, Germany
                [b ]MVZ MEDILYS Laborgesellschaft mbH, Hamburg, Germany
                [c ]Sysmex Europe SE, Norderstedt, Germany
                [d ]Sysmex Corporation, Kobe, Japan
                Author notes
                [∗ ]Corresponding author. Sysmex Europe SE, Bornbarch 1, 22848, Norderstedt, Germany. valina.ondrej@ 123456sysmex-europe.com
                Article
                Publisher Item ID: S2352-5517(24)00016-7 Publisher ID: e00370
                DOI: 10.1016/j.plabm.2024.e00370
                PMC ID: 10884972
                SO-VID: dbb8d464-fe82-4583-89a1-8d7dbf55e9bc
                Copyright © © 2024 The Authors. Published by Elsevier B.V.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 30 June 2023
                Date revision received : 6 February 2024
                Date accepted : 14 February 2024
                Categories
                Subject: Original Research Article

                Keywords: sysmex xn-series,sysmex xr-series,whole blood analysis,analytical performance,method comparison,flagging performance
                Data availability:
                Keywords: sysmex xn-series, sysmex xr-series, whole blood analysis, analytical performance, method comparison, flagging performance

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