{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T01:50:33Z","timestamp":1785894633713,"version":"3.56.0"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T00:00:00Z","timestamp":1626048000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Lab Hematology"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The Sysmex CN\u20106500 is a new haemostasis analyser with an integrated immunoassay module that performs chemiluminescence enzyme assay (CLEIA) in addition to coagulation, turbidimetric, chromogenic and platelet aggregation tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>To evaluate the analytical performance of the CN\u20106500 against the predicate device (Sysmex HISCL\u2010800) for soluble thrombomodulin (TM), thrombin\u2010antithrombin (TAT), tissue plasminogen activator\/plasminogen activator inhibitor 1 complex (tPAI\u2010C) and plasmin \u03b12 plasmin inhibitor complex (PIC) assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Imprecision was assessed by testing two levels of quality control plasmas 10 times on 5 separate days. Comparability was studied in 230 plasmas from normal donors (n\u00a0=\u00a030), patients with suspected disseminated intravascular coagulation (DIC, n\u00a0=\u00a0100), sepsis (n\u00a0=\u00a020) or liver disease (n\u00a0=\u00a020), lipaemic (n\u00a0=\u00a020), haemolysed (n\u00a0=\u00a020) and icteric samples (n\u00a0=\u00a020). Limit of detection, limit of quantitation and linearity were determined by testing serial dilutions of normal plasma. Sample carryover was assessed by testing samples with high and low normal levels of the analytes concerned.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The CN\u20106500 performed 21 CLEIA tests per hour, while simultaneously performing coagulation tests. Acceptable between\u2010run imprecision was obtained using commercial controls with normal and high activity for each analyte (%CV &lt;4%), for all four assays. Excellent linearity was observed (slope 0.89\u20101.03; r<jats:sup>2<\/jats:sup> &gt;0.99) across the measurement range. The lower limits of detection and quantitation were as follows: TM &lt;0.3\/0.6 TU\/ml, TAT &gt;0.1\/&lt;0.2\u00a0ng\/ml, PIC &lt;0.004\/&lt;0.008\u00a0\u00b5g\/ml and tPAI\u2010C\u00a0&lt;\u00a00.01\/&lt;0.1\u00a0ng\/ml, respectively. All four assays showed excellent correlation between analysers and were unaffected by haemolysis, icterus or lipaemia. No carryover was observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our data demonstrate that the performance of the CLEIA assays on the CN\u20106500 is comparable to that of a stand\u2010alone immunoassay analyser.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ijlh.13656","type":"journal-article","created":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T16:53:20Z","timestamp":1626108800000},"page":"1593-1598","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A performance evaluation of chemiluminescence enzyme immunoassays on the Sysmex CN\u20106500 haemostasis analyser"],"prefix":"10.1111","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2318-0062","authenticated-orcid":false,"given":"Chris","family":"Gardiner","sequence":"first","affiliation":[{"name":"Research Department of Haematology University College London London UK"},{"name":"Chris Gardiner Consulting Ltd. Aylesbury Buckinghamshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Lane","sequence":"additional","affiliation":[{"name":"Research Department of Haematology University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3615-7889","authenticated-orcid":false,"given":"Hitesh","family":"Tailor","sequence":"additional","affiliation":[{"name":"Haematology Evaluations Unit HSL (Analytics) LLP London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel J.","family":"Machin","sequence":"additional","affiliation":[{"name":"Research Department of Haematology University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7393-2365","authenticated-orcid":false,"given":"Ian J.","family":"Mackie","sequence":"additional","affiliation":[{"name":"Research Department of Haematology University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,12]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13271"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13317-017-0097-2"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.22913"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12959-016-0117-x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2018.11.010"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13194"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-019-2552-0"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/107602960100700309"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14988"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0241329"},{"key":"e_1_2_8_12_1","first-page":"1","volume-title":"H57\u2010A Protocol for the Evaluation, Validation, and Implementation of Coagulometers","author":"Clinical Laboratory Standards Institute","year":"2008"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13411"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.12498"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.22921"},{"key":"e_1_2_8_16_1","first-page":"417","article-title":"Analytical and clinical evaluation of chemiluminescent carcinoembryonic antigen (CEA) by HISCL\u20105000 Immunoanalyzer","volume":"50","author":"Jekarl DW","year":"2020","journal-title":"Ann Clin Lab Sci"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.21037\/atm.2019.05.83"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2006.02237.x"}],"container-title":["International Journal of Laboratory Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ijlh.13656","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ijlh.13656","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ijlh.13656","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T08:53:41Z","timestamp":1693212821000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ijlh.13656"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,12]]},"references-count":17,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["10.1111\/ijlh.13656"],"URL":"https:\/\/doi.org\/10.1111\/ijlh.13656","archive":["Portico"],"relation":{},"ISSN":["1751-5521","1751-553X"],"issn-type":[{"value":"1751-5521","type":"print"},{"value":"1751-553X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,12]]},"assertion":[{"value":"2021-03-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}