{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:42:37Z","timestamp":1785300157723,"version":"3.55.0"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T00:00:00Z","timestamp":1756771200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T00:00:00Z","timestamp":1756771200000},"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":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Discrepancies in factor IX activity (FIX:C) measurements between one\u2010stage clotting assays (OSAs) have been observed following infusion with recombinant factor IX extended half\u2010life concentrates (EHL\u2010rFIX) in the treatment of haemophilia B. These variations, primarily due to differences in activated partial thromboplastin time (APTT) reagents, complicate clinical decision\u2010making.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The aim of this study was to evaluate whether drug\u2010specific calibrations for albumin\u2010fused recombinant FIX (rFIX\u2010FP) and Fc\u2010fused recombinant FIX (rFIX\u2010Fc) could reduce inter\u2010reagent discrepancies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In a multicentre field study involving 20 laboratories, plasma samples spiked with rFIX\u2010FP, rFIX\u2010Fc or standard rFIX were tested using different APTT reagents. FIX:C was measured with usual and drug\u2010specific calibration. Data were analysed for compliance (target range: 80%\u2013120% of expected values), interlaboratory variability and intralaboratory reproducibility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Usual calibration resulted in significant discrepancies among reagents, with compliance rates varying widely. Drug\u2010specific calibration significantly improved compliance for all reagents tested, except for one concentration with rFIX\u2010Fc. Interlaboratory variability decreased markedly, with coefficients of variation dropping from 19.4%\u201336.0% (usual calibration) to 6.0%\u201312.4% (specific calibration). Intralaboratory reproducibility was consistent whatever the type of calibration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Drug\u2010specific calibration for EHL\u2010rFIX reduces reagent\u2010related variability in OSA FIX assays, ensuring reliable and standardised results. This approach facilitates monitoring with a single reagent system, improving laboratory efficiency. Wider availability of validated calibrators remains crucial for broader adoption and standardisation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70115","type":"journal-article","created":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T06:46:13Z","timestamp":1756881973000},"page":"1307-1314","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Drug\u2010Specific Calibration: A Solution to Reagent Variability in Extended Half\u2010Life Factor IX Activity Measurements"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5955-5460","authenticated-orcid":false,"given":"Fran\u00e7ois","family":"Grand","sequence":"first","affiliation":[{"name":"CHU de Poitiers, Laboratoire d'h\u00e9matologie biologique  Poitiers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Blanc\u2010Jouvan","sequence":"additional","affiliation":[{"name":"Laboratoire d'h\u00e9matologie, Centre Hospitalier Annecy Genevois  Epagny Metz\u2010Tessy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Mourey","sequence":"additional","affiliation":[{"name":"Laboratoire de Biologie M\u00e9dicale, Secteur d'H\u00e9mostase Biologique, CHU Besan\u00e7on  Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Ryman","sequence":"additional","affiliation":[{"name":"CHU de Bordeaux, H\u00f4pital Cardiologique, Laboratoire d'H\u00e9mostase  Pessac Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Eschwege","sequence":"additional","affiliation":[{"name":"Service d'H\u00e9matologie Biologique, CHRU de Nancy  Nancy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Brionne\u2010Fran\u00e7ois","sequence":"additional","affiliation":[{"name":"Laboratoire d'H\u00e9matologie, CHU Caen Normandie  Caen France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6600-0263","authenticated-orcid":false,"given":"Dominique","family":"Lasne","sequence":"additional","affiliation":[{"name":"Laboratoire d'h\u00e9matologie, AP\u2010HP, H\u00f4pital Universitaire Necker\u2010Enfants Malades  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Voisin","sequence":"additional","affiliation":[{"name":"CHU Toulouse laboratoire h\u00e9matologie. H\u00f4pital Rangueil  Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00e9ronique","family":"Le Cam\u2010Duchez","sequence":"additional","affiliation":[{"name":"CHU Rouen, Hematologie Biologique  Rouen France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Diaz\u2010Cau","sequence":"additional","affiliation":[{"name":"CHU Montpellier, H\u00e9matologie Biologique  Montpellier France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3662-3416","authenticated-orcid":false,"given":"Claire","family":"Flaujac","sequence":"additional","affiliation":[{"name":"Service de Biologie, Secteur H\u00e9mostase Centre Hospitalier de Versailles \u2010 Andr\u00e9 Mignot  Le Chesnay\u2010Rocquencourt France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Noyel","sequence":"additional","affiliation":[{"name":"CHU de Saint\u2010Etienne, Laboratoire d'h\u00e9matologie  St Priest en Jarez France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecile","family":"Lavenu\u2010Bombled","sequence":"additional","affiliation":[{"name":"Service H\u00e9matologie Biologique, APHP, CHU Bic\u00eatre, Le Kremlin\u2010Bic\u00eatre; CRC Fili\u00e8re MHEMO  Le Kremlin Bic\u00eatre France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Demaistre","sequence":"additional","affiliation":[{"name":"CHU Dijon, Laboratoire d'H\u00e9mostase  Dijon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuelle","family":"Jeanpierre","sequence":"additional","affiliation":[{"name":"Service d'H\u00e9matologie\u2010Transfusion, CHU De Lille  Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magali","family":"Donnard","sequence":"additional","affiliation":[{"name":"Laboratoire d'h\u00e9matologie Biologique CBRS CHU Dupuytren  Limoges 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FIX C Assessment of Extended Half\u2010Life Recombinant Factor IX Products in Clinical Practice","volume":"24","author":"Bowyer 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