{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T03:38:02Z","timestamp":1792208282055,"version":"4.4.0"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Patients with Haemophilia A treated with Mim8 may require concomitant Factor VIII (FVIII) replacement; hence, accurate assessment of FVIII activity (FVIII:C) and FVIII inhibitors in the presence of Mim8 is important.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Assess which chromogenic substrate assays (CSAs) accurately monitor FVIII:C and FVIII inhibitor levels in the presence of Mim8.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>FVIII and Mim8 were spiked into congenital FVIII\u2010deficient plasma to obtain mixtures containing various FVIII:C levels (0\u2013100\u00a0IU\/dL) and Mim8 concentrations (0, 3, 6 and 12\u00a0\u00b5g\/mL). Five CSAs using different activated Factor IX and X sources (bovine, bovine\u2013human or human) were used to measure FVIII:C. Bovine and bovine\u2013human CSAs were then used to measure FVIII:C of standard half\u2010life (SHL) and extended half\u2010life (EHL) FVIII products. FVIII inhibitor levels were assessed using two different bovine CSAs in congenital FVIII\u2010deficient plasma spiked with various Mim8 concentrations (5, 10, 20 and 40\u00a0\u00b5g\/mL) and FVIII inhibitor levels (0.2, 1.0 and 4.8 BU).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>High levels of interference were observed using human CSAs. Bovine CSAs accurately measured FVIII:C of SHL and EHL FVIII products in the presence of Mim8 without interference. In bovine\u2013human CSAs, interference was observed at 5\u00a0IU\/dL FVIII, increasing up to four\u2010fold with increasing Mim8 levels. FVIII inhibitor levels were accurately measured using bovine CSAs without Mim8 interference.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>FVIII:C of SHL and EHL products and FVIII inhibitor levels can be accurately monitored in the presence of Mim8 using bovine CSAs at all FVIII levels, and bovine\u2013human CSAs at FVIII concentrations &gt;20\u00a0IU\/dL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70007","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T05:37:12Z","timestamp":1739511432000},"page":"319-327","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Factor VIII Activity and Factor VIII Inhibitors Can Be Measured Accurately in Plasma Containing Mim8 by Using Specific Chromogenic Assays"],"prefix":"10.1111","volume":"31","author":[{"given":"William","family":"Pickering","sequence":"first","affiliation":[{"name":"Laboratory Corporation of America Holdings  Englewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Robinson","sequence":"additional","affiliation":[{"name":"Laboratory Corporation of America Holdings  Englewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Cogswell","sequence":"additional","affiliation":[{"name":"Laboratory Corporation of America Holdings  Englewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan Hui Ong","family":"Clausen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin Nana","family":"Weldingh","sequence":"additional","affiliation":[{"name":"Novo Nordisk Park  M\u00e5l\u00f8v Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4380-5899","authenticated-orcid":false,"given":"Mirella","family":"Ezban","sequence":"additional","affiliation":[{"name":"Novo Nordisk Park  M\u00e5l\u00f8v Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-08-872291"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020010331"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.14746"},{"issue":"1","key":"e_1_2_11_6_1","article-title":"A Novel FVIIIa\u2010Mimetic Bispecific Antibody, Mim8, Enhances FIXa Proteolytic Activity While Allowing for Efficient, Lipid\u2010Dependent Assembly With FX [Abstract]","volume":"4","author":"Lund 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E.","year":"2018","journal-title":"Anaesthesia"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13990"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.14021"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2022.12.023"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13903"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0039-1692427"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.13384"},{"key":"e_1_2_11_19_1","article-title":"Measurement of FVIII Activity of Different Products in the Presence of Mim8 Using Selected FVIII Chromogenic Assays","author":"Pickering W.","year":"2023","journal-title":"ISTH"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14831"},{"key":"e_1_2_11_21_1","first-page":"724","article-title":"Factor VIII (FVIII) Inhibitor Testing Using a Validated Chromogenic Bethesda Assay (CBA) in HAVEN 1 (BH29884), a Phase 3 Trial of Emicizumab in Persons With Hemophilia A (PwHA) With Inhibitors","volume":"1","author":"Adamkewicz J.","year":"2017","journal-title":"Research and Practice in Thrombosis and Haemostasis"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70007","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hae.70007","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.70007","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T17:17:58Z","timestamp":1772990278000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.70007"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,14]]},"references-count":20,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,3]]}},"alternative-id":["10.1111\/hae.70007"],"URL":"https:\/\/doi.org\/10.1111\/hae.70007","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,14]]},"assertion":[{"value":"2024-09-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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