{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T10:13:58Z","timestamp":1789812838623,"version":"4.0.1"},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T00:00:00Z","timestamp":1783209600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T00:00:00Z","timestamp":1783209600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Introduction<\/jats:title>\n Accurate monitoring of treatment with modified factor VIII products remains challenging, due to known variability in assay performance across different laboratory methods and reagents. For the extended half\u2010life product Damoctocog alfa pegol discrepancies have been reported.<\/jats:p>\n <\/jats:sec>\n \n Aims<\/jats:title>\n This multicentre field study was designed to evaluate the analytical accuracy of Damoctocog alfa pegol using various methods for one\u2010stage clotting and chromogenic assays.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The study was conducted under conditions closely mimicking routine laboratory settings. Five plasma samples were spiked with varying concentrations of Damoctocog alfa pegol (0.05 to 1.3 IU\/ml) and distributed to 118 participating laboratories. FVIII activity of the samples was analysed using 12 one\u2010stage and 7 chromogenic methods. Accuracy results were evaluated per specific reagent with a maximal acceptable mean bias of 20% from the target. Interlaboratory variation was established for reagents with \u22653 participants.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The reliability of factor VIII measurements differ between the tested reagents. Usage of SynthasIL and Pathromtin (one stage) and Biophen (chromogenic) is in most cases reliable, although inter\u2010lab variation contributes to inaccuracy. The reagents STA PTT A and Triniclot (one stage), as well as Siemens (chromogenic) (strongly) underestimate FVIII activity and are therefore unsuitable for accurate measurement of Damoctocog alfa pegol.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n We have evaluated accuracy results for 19 Factor VIII assays in order to provide evidence\u2010based guidance for clinical laboratories in selecting appropriate assay methodologies for reliable quantification of the activity of Damoctocog alfa pegol. Assay performance should be locally validated as large interlaboratory variation is observed.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/hae.70350","type":"journal-article","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T06:31:30Z","timestamp":1783319490000},"page":"1282-1287","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Accuracy of Factor VIII Assays for Measuring Damoctocog Alfa Pegol: A Comparative Analysis"],"prefix":"10.1111","volume":"32","author":[{"given":"Judith C. A.","family":"Cluitmans","sequence":"first","affiliation":[{"name":"Department of Clinical Chemistry and Haematology Jeroen Bosch Hospital \u2019s\u2010Hertogenbosch the Netherlands"},{"name":"Department of Laboratory Medicine, Radboudumc Laboratory for Diagnostics Radboudumc Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piet","family":"Meijer","sequence":"additional","affiliation":[{"name":"ECAT foundation Voorschoten the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanna R.","family":"Rijpma","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Laboratory of Haematology Radboudumc Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"An K.","family":"Stroobants","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Radboudumc Laboratory for Diagnostics Radboudumc Nijmegen the Netherlands"},{"name":"Department of Laboratory Medicine, Laboratory of Haematology Radboudumc Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,5]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1511769"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rpth.2023.102308"},{"issue":"6","key":"e_1_2_10_5_1","first-page":"479","article-title":"Factor VIII Replacement Is Still the Standard of Care in Haemophilia A","volume":"17","author":"Aledort L.","year":"2019","journal-title":"Blood Transfusion"},{"key":"e_1_2_10_6_1","unstructured":"European Medicines Agency [internet] Jivi Summary of Product Characteristics.2018. [Accessed on 11\/01\/2019].https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/jivi\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13564"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12374"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.70044"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.15425"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.14258"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13907"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2015.10.003"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13643"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2024.05.026"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14866"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2025.01.024"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70350","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hae.70350","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70350","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T09:41:52Z","timestamp":1789810912000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.70350"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,5]]},"references-count":16,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1111\/hae.70350"],"URL":"https:\/\/doi.org\/10.1111\/hae.70350","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,5]]},"assertion":[{"value":"2026-03-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}