{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T14:57:29Z","timestamp":1792594649483,"version":"4.5.0"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T00:00:00Z","timestamp":1698624000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Structural and chemical modifications of factor VIII (FVIII) products may influence their behaviour in FVIII activity assays. Hence, it is important to assess the performance of FVIII products in these assays. Efanesoctocog alfa is a new class of FVIII replacement therapy designed to provide both high sustained factor activity levels and prolonged plasma half\u2010life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>Evaluate the accuracy of measuring efanesoctocog alfa FVIII activity in one\u2010stage clotting assays (OSAs) and chromogenic substrate assays (CSAs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Human plasma with no detectable FVIII activity was spiked with efanesoctocog alfa or a full\u2010length recombinant FVIII product comparator, octocog alfa, at nominal concentrations of 0.80 IU\/mL, 0.20 IU\/mL, or 0.05 IU\/mL, based on labelled potency. Clinical haemostasis laboratories (<jats:italic>N<\/jats:italic>\u00a0=\u00a035) tested blinded samples using in\u2010house assays. Data from 51 OSAs (14 activated partial thromboplastin time [aPTT] reagents) and 42 CSAs (eight kits) were analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Efanesoctocog alfa activity was reliably (\u00b125% of nominal activity) measured across all concentrations using OSAs with Actin FSL and multiple other aPTT reagents. Under\u2010 and overestimation of FVIII activity occurred with some reagents. No specific trend was observed for any class of aPTT activators. A two\u2010 to three\u2010fold overestimation was consistently observed using CSAs and the OSA with Actin FS as the aPTT reagent across evaluated concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Under\u2010 or overestimation occurred with some specific OSAs and most CSAs, which has been previously observed with other modified FVIII replacement products. Efanesoctocog alfa FVIII activity was measured with acceptable accuracy and reliability using several OSA methods and commercial plasma standards.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14831","type":"journal-article","created":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T13:04:26Z","timestamp":1698671066000},"page":"214-223","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["A global comparative field study to evaluate the factor VIII activity of efanesoctocog alfa by one\u2010stage clotting and chromogenic substrate assays at clinical haemostasis laboratories"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2558-2089","authenticated-orcid":false,"given":"Steven","family":"Pipe","sequence":"first","affiliation":[{"name":"Departments of Pediatrics and Pathology University of Michigan  Ann Arbor Michigan 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