{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:56:17Z","timestamp":1753869377912,"version":"3.41.2"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,3,11]],"date-time":"2022-03-11T00:00:00Z","timestamp":1646956800000},"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":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>We conducted a multicenter evaluation of a new one\u2010stage factor VIII (FVIII) assay (Roche Diagnostics), intended for the quantitative assessment of FVIII activity. We evaluated the analytical performance of the FVIII assay on the cobas t 711 analyzer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Experiments performed at three laboratories used 3.2% citrated residual or commercially purchased plasma samples. Five human plasma pools and two controls were used to determine assay within\u2010run and within\u2010laboratory precision, and total reproducibility; coefficients of variation (CVs) and\/or standard deviations (SDs) were calculated. Lot\u2010to\u2010lot variability and method comparison (vs Coagulation FVIII Deficient Plasma\/Dade Actin FS Activated PTT reagent\/Standard Human Plasma Calibrator on the Sysmex CS\u20105100 analyzer; Siemens Healthineers) were evaluated by Passing\u2013Bablok and Deming regression, respectively, and Pearson's <jats:italic>r<\/jats:italic> calculated. Assay\u2010specific reference range was determined using 199 fresh plasma samples from healthy adults, not receiving anticoagulants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Across sites, SDs for repeatability were 0.016\u20130.046 for samples with \u22641.0 international units (IU)\/dL FVIII activity; CVs were 0.9%\u20133.8% for samples with &gt;1.0\u00a0IU\/dl activity. Among samples with mean FVIII activity 0.344\u2013133\u00a0IU\/dl, good intermediate precision (SD 0.020 for samples with 0.344\u00a0IU\/dl activity; CV 1.8%\u20134.7%) and good total reproducibility (CV 2.0%\u201313.3%) were observed. The FVIII assay showed excellent lot\u2010to\u2010lot variability (Pearson's <jats:italic>r<\/jats:italic>\u00a0=\u00a0.999) and good correlation with the comparator assay (Pearson's <jats:italic>r<\/jats:italic>\u00a0=\u00a0.993\u2013.996). The reference range for FVIII activity was 82.2\u2212218.0\u00a0IU\/dl.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The one\u2010stage FVIII assay demonstrated robust analytical performance on the cobas t 711 analyzer, supporting its use in routine laboratory practice.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24294","type":"journal-article","created":{"date-parts":[[2022,3,11]],"date-time":"2022-03-11T11:23:15Z","timestamp":1646997795000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Multicenter performance evaluation and reference range determination of a new one\u2010stage factor VIII assay"],"prefix":"10.1002","volume":"36","author":[{"given":"Anna E.","family":"Lowe","sequence":"first","affiliation":[{"name":"Sheffield Haemophilia and Thrombosis Centre  Sheffield 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