{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T02:48:12Z","timestamp":1777949292973,"version":"3.51.4"},"reference-count":18,"publisher":"Georg Thieme Verlag KG","license":[{"start":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T00:00:00Z","timestamp":1776643200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thromb Haemost"],"abstract":"<jats:p>For the diagnosis and therapeutic monitoring of bleeding disorders as well as for thrombotic risk assessment, reliable measurement of factor VIII (FVIII) coagulant activity is required. The complex FVIII structure and limited stability pose major challenges in hemostaseological diagnostics concerning the preanalytical handling and the availability of commutable control and calibrator materials. The aim of this study was to assess the commutability of frozen and lyophilized patient plasma and routinely used external quality assessment materials (EQAMs) for FVIII activity measurement.<\/jats:p>\n                  <jats:p>FVIII activity was measured in 97 native plasma samples covering a broad activity range using clotting tests and chromogenic assays from two manufacturers. Corresponding frozen and lyophilized aliquots as well as four commercially available lyophilized control materials from three manufacturers were analyzed the same way. Commutability was assessed by comparing the mean natural logarithmic differences of candidate materials from those of native plasma using Bland-Altman plots. A commutability criterion was defined with respect to the intended use of the materials as EQAMs, based on the mean\u2009\u00b1\u20092 standard deviations derived from the distribution of natural logarithmic differences in native plasma samples.<\/jats:p>\n                  <jats:p>Native plasma measurements showed good agreement across the four methods. Method-specific effects on FVIII activity measurement were minor after freezing, but more pronounced after lyophilization. Nevertheless, mean differences observed for frozen and lyophilized plasma remained within the predefined commutability criterion. All investigated EQAMs were deemed commutable for their intended use in external quality assessment. All in all, commutability studies for FVIII activity measurement are feasible but resource-intensive.<\/jats:p>","DOI":"10.1055\/a-2852-9387","type":"journal-article","created":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T22:30:32Z","timestamp":1777847432000},"source":"Crossref","is-referenced-by-count":0,"title":["Assessment of Commutability in Factor VIII Activity Testing Using Fresh Human Plasma Samples"],"prefix":"10.1055","author":[{"given":"Laura","family":"Vierbaum","sequence":"additional","affiliation":[{"name":"INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Weigand","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mira","family":"Ganslmeier","sequence":"additional","affiliation":[{"name":"Department of Transfusion Medicine, Cellular Therapeutics and Hemostaseology, Clinic for Anesthesiology, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dorothea","family":"Fichtl","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Teupser","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Spannagl","sequence":"additional","affiliation":[{"name":"INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, Germany"},{"name":"Institute of Laboratory Medicine, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Moehnle","sequence":"additional","affiliation":[{"name":"Department of Transfusion Medicine, Cellular Therapeutics and Hemostaseology, Clinic for Anesthesiology, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias","family":"Bruegel","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Medicine, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2026,5,3]]},"reference":[{"issue":"06","key":"ref1","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1055\/s-0042-1758870","article-title":"Factor VIII and factor IX activity measurements for hemophilia diagnosis and related treatments","volume":"49","author":"A E Bowyer","year":"2023","journal-title":"Semin Thromb Hemost"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/j.thromres.2023.06.026","article-title":"Plasma levels of coagulation factors VIII and IX and risk of venous thromboembolism: systematic review and meta-analysis","volume":"229","author":"G Lowe","year":"2023","journal-title":"Thromb Res"},{"issue":"03","key":"ref3","doi-asserted-by":"crossref","first-page":"560","DOI":"10.1055\/s-0037-1615621","article-title":"Definitions in hemophilia. Recommendation of the scientific subcommittee on factor VIII and factor IX of the scientific and standardization committee of the International Society on Thrombosis and Haemostasis","volume":"85","author":"G C White II","year":"2001","journal-title":"Thromb Haemost"},{"issue":"05","key":"ref4","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1515\/cclm-2013-0705","article-title":"Effect of biobanking conditions on short-term stability of biomarkers in human serum and plasma","volume":"52","author":"J Zander","year":"2014","journal-title":"Clin Chem Lab Med"},{"issue":"03","key":"ref5","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1373\/clinchem.2017.277541","article-title":"IFCC Working Group recommendations for assessing commutability Part 2: using the difference in bias between a reference material and clinical samples","volume":"64","author":"G Nilsson","year":"2018","journal-title":"Clin Chem"},{"issue":"03","key":"ref6","doi-asserted-by":"crossref","first-page":"619","DOI":"10.1111\/ijlh.13795","article-title":"External quality assessment for one-stage and chromogenic factor IX assays in samples containing Alprolix (rFIXFc) or Idelvion (rIX-FP) and evidence that UK National External Quality Assessment Scheme for blood coagulation samples are commutable with patient samples","volume":"44","author":"S Kitchen","year":"2022","journal-title":"Int J Lab Hematol"},{"issue":"01","key":"ref7","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1111\/ijlh.12918","article-title":"The importance of commutability in material used for quality control purposes","volume":"41","author":"I Jennings","year":"2019","journal-title":"Int J Lab Hematol"},{"issue":"02","key":"ref8","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1111\/ijlh.12940","article-title":"Clotting and chromogenic factor VIII assay variability in post-infusion and spiked samples containing full-length recombinant FVIII or recombinant factor VIII Fc fusion protein (rFVIIIFc)","volume":"41","author":"S Kitchen","year":"2019","journal-title":"Int J Lab Hematol"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"1416642","DOI":"10.3389\/fmed.2024.1416642","article-title":"Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs","volume":"11","author":"L Vierbaum","year":"2024","journal-title":"Front Med (Lausanne)"},{"issue":"34","key":"ref10","first-page":"2754","article-title":"[Commutability of reference materials for coagulation factor VIII and factor IX activity on three measurement systems] [in Chinese]","volume":"95","author":"W Zhou","year":"2015","journal-title":"Zhonghua Yi Xue Za Zhi"},{"issue":"01","key":"ref11","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1111\/j.1365-2141.2005.05829.x","article-title":"Harmonisation of factor VIII:C assay results: study within the framework of the Dutch project \u201cCalibration 2000.\u201d","volume":"132","author":"A M van den Besselaar","year":"2006","journal-title":"Br J Haematol"},{"issue":"8476","key":"ref15","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1016\/S0140-6736(86)90837-8","article-title":"Statistical methods for assessing agreement between two methods of clinical measurement","volume":"1","author":"J M Bland","year":"1986","journal-title":"Lancet"},{"issue":"06","key":"ref16","doi-asserted-by":"crossref","first-page":"810","DOI":"10.1111\/ijlh.13277","article-title":"The traceability of commercial plasma calibrators to the plasma International Standards for factor VIII and factor IX","volume":"42","author":"H V Wilmot","year":"2020","journal-title":"Int J Lab Hematol"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/j.ijbiomac.2020.11.188","article-title":"Instability of therapeutic proteins\u2014an overview of stresses, stabilization mechanisms and analytical techniques involved in lyophilized proteins","volume":"167","author":"A Butreddy","year":"2021","journal-title":"Int J Biol Macromol"},{"issue":"12","key":"ref18","doi-asserted-by":"crossref","first-page":"2019","DOI":"10.3390\/diagnostics13122019","article-title":"Longitudinal evaluation of AFP and CEA external proficiency testing reveals need for method harmonization","volume":"13","author":"N Wojtalewicz","year":"2023","journal-title":"Diagnostics (Basel)"},{"issue":"09","key":"ref19","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1093\/clinchem\/hvad104","article-title":"Recommendations for setting a criterion for assessing commutability of secondary calibrator certified reference materials","volume":"69","author":"W G Miller","year":"2023","journal-title":"Clin Chem"},{"issue":"07","key":"ref20","doi-asserted-by":"crossref","first-page":"2503","DOI":"10.1007\/s00216-006-0855-x","article-title":"Impact of residual moisture and formulation on factor VIII and factor V recovery in lyophilized plasma reference materials","volume":"387","author":"A Hubbard","year":"2007","journal-title":"Anal Bioanal Chem"},{"issue":"03","key":"ref21","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1055\/s-2002-32658","article-title":"Coagulation and chromogenic assays of factor VIII activity: general aspects, standardization, and recommendations","volume":"28","author":"T W Barrowcliffe","year":"2002","journal-title":"Semin Thromb Hemost"}],"container-title":["Thrombosis and Haemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2852-9387.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T22:30:34Z","timestamp":1777847434000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2852-9387"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,20]]},"references-count":18,"URL":"https:\/\/doi.org\/10.1055\/a-2852-9387","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0340-6245","2567-689X"],"issn-type":[{"value":"0340-6245","type":"print"},{"value":"2567-689X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,4,20]]},"published":{"date-parts":[[2026,4,20]]}}}