{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T16:15:06Z","timestamp":1777479306314,"version":"3.51.4"},"reference-count":31,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100009431","name":"Baxalta","doi-asserted-by":"publisher","award":["IIR-SWE-BXLT-001972\/ IISR-2017-104237"],"award-info":[{"award-number":["IIR-SWE-BXLT-001972\/ IISR-2017-104237"]}],"id":[{"id":"10.13039\/100009431","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Appl Thromb Hemost"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Emicizumab has emerged as a promising therapy for hemophilia A (HA), employing a bypassing mechanism to restore hemostasis. However, since the traditional factor assays cannot be used for measuring the effect of emicizumab, treatment monitoring is difficult.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the impact of emicizumab on global hemostatic potential (OHP), as well as on chromogenic and modified one-stage (mOSA) FVIII assays calibrated for emicizumab in patient samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Peripheral blood samples from patients with HA on emicizumab were utilized for a validation (n\u2009=\u200928) and a clinical cohort (n\u2009=\u20099). Emicizumab concentration was measured by chromogenic FVIII and mOSA (Actin FS, Actin FSL, and PTT-LA), while overall haemostatic potential (OHP) was used to assess global hemostasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Significantly lower emicizumab concentrations were observed using chromogenic FVIII assay compared to mOSA (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.005,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.005, and\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.005 for mOSA Actin FSL, mOSA Actin FS, and mOSA PTT-LA respectively) in the validation cohort. In the clinical cohort, emicizumab concentrations were significantly lower with chromogenic FVIII assay compared to mOSA Actin FS (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.005) and mOSA PTT-LA (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.009), but not mOSA Actin FSL. In the clinical cohort, no correlation was seen between OHP and emicizumab.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Accurate measurement of emicizumab concentration may have the potential to understand assay variability, which is important for informed clinical decision-making in HA patients. Our findings underscore the need for introducing new methods for measuring emicizumab concentration and suggest chromogenic-based methodologies as a viable option for mitigating assay interference.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10760296251378458","type":"journal-article","created":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T18:42:57Z","timestamp":1758912177000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Laboratory Assessment of Emicizumab Levels in Hemophilia A: Influence of Assay Selection on Reported Results"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6069-6615","authenticated-orcid":false,"given":"Charlotte","family":"Gran","sequence":"first","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"},{"name":"Clinical Chemistry, Medical Diagnostics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tony","family":"Frisk","sequence":"additional","affiliation":[{"name":"Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Pediatric Oncology, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margareta","family":"Homstr\u00f6m","sequence":"additional","affiliation":[{"name":"Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Haematology, Coagulation Unit, Karolinska University Hospital, Stockholm, Sweden"},{"name":"Department of Health, Medicine and Caring Sciences, Link\u00f6ping University, Link\u00f6ping, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Magnusson","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Clinical Science, Intervention &amp; Technology, Division of Paediatrics, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Haematology, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanna","family":"Ranta","sequence":"additional","affiliation":[{"name":"Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden"},{"name":"Pediatric Coagulation Unit, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Sj\u00f6str\u00f6m","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"},{"name":"Clinical Chemistry, Medical Diagnostics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marjan Shafaati","family":"Lambert","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nida Mahmoud Hourani","family":"Soutari","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jovan P.","family":"Antovic","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"},{"name":"Clinical Chemistry, Medical Diagnostics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9069-1903","authenticated-orcid":false,"given":"Roza","family":"Chaireti","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Surgery, Coagulation Research, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Haematology, Karolinska University Hospital, Stockholm, 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