{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T16:35:49Z","timestamp":1778776549883,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T00:00:00Z","timestamp":1694563200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Lab Hematology"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Haemophilia B (HB) is an X\u2010linked hereditary bleeding disorder characterized by coagulation factor IX (FIX) deficiency. To improve the quality of life of patients and adherence to treatment, recombinant factor concentrates modified to extend their half\u2010life have been developed, called extended half\u2010life factors (EHL: extended half\u2010life). Nonacog beta pegol (N9\u2010GP) is a glycopegylated recombinant human FIX molecule that has a half\u2010life of 93\u2009h with a single dose and has shown a higher recovery percentage than other molecules. To diagnose and monitor the treatment of haemophiliac patients, FIX activity is determined with the one\u2010stage clotting assay (OSA) and\/or the chromogenic assay. The objective of this work, carried out in three centres, was to measure the recovery of N9\u2010PG with 10 different activated partial thromboplastin time (APTT) reagents on three platforms, in samples spiked in vitro with N9\u2010GP, at four different concentration levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>It was measured the recovery of N9\u2010GP with 10 different APTT reagents (polyphenol, ellagic acid, silice dioxide, colloidal silica as APTT activator on three platforms, in sample spiked in vitro with N9\u2010GP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The results show heterogeneity in the activity of N9\u2010GP measured by OSA with the different APTT reagents when the calibrations were performed with the specific calibrator of each coagulometer. A recovery percentage between 87% and 108% was obtained only with polyphenol and ellagic acid as activator in the three platforms evaluated. The other reagents studied overestimate or underestimate, with no clear profile. When a calibration curve was performed with a calibrator prepared from the N9\u2010GP vial, all APTT reagents met the established recovery requirement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>APTT reagents with polyphenol or ellagic acid as activator would be the only ones appropriate when using the commercially available OSA with specific calibrator to monitor patients treated with N9\u2010GP.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ijlh.14171","type":"journal-article","created":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T00:58:15Z","timestamp":1694653095000},"page":"128-134","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["High variability in Factor <scp>IX<\/scp> one\u2010stage assay in samples spiked with nonacog beta pegol among different pairs of reagent\/detection system"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0490-6972","authenticated-orcid":false,"given":"C.","family":"Duboscq","sequence":"first","affiliation":[{"name":"Servicio Hematolog\u00eda Hospital Brit\u00e1nico  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Sueldo","sequence":"additional","affiliation":[{"name":"Laboratorio de Hematolog\u00eda Y Hemostasia Hospital Dr. C\u00e9sar Milstein  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-4465","authenticated-orcid":false,"given":"C.","family":"Rosa","sequence":"additional","affiliation":[{"name":"Laboratorio Central Hospital Hospital Universitario Austral  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Zirpoli","sequence":"additional","affiliation":[{"name":"Laboratorio Central Hospital Hospital Universitario Austral  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Ceresetto","sequence":"additional","affiliation":[{"name":"Servicio Hematolog\u00eda Hospital Brit\u00e1nico  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Baques","sequence":"additional","affiliation":[{"name":"Servicio de Hemofilia Dr. C\u00e9sar Milstein  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Arias","sequence":"additional","affiliation":[{"name":"Laboratorio de Hematolog\u00eda Y Hemostasia Hospital Dr. C\u00e9sar Milstein  Buenos Aires Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,9,13]]},"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":"10.1016\/j.biologicals.2020.07.009"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13012"},{"issue":"15","key":"e_1_2_10_5_1","first-page":"221","article-title":"Recent advances in the treatment of hemophilia: a review","volume":"15","author":"Marchesini E","year":"2021","journal-title":"Biol 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de productos de vida media extendida en pacientes con hemofilia B","volume":"25","author":"Arias M","year":"2021","journal-title":"Revista Hematolog\u00eda"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/rth2.12046"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13359"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13907"},{"key":"e_1_2_10_22_1","first-page":"36","article-title":"Survey 2016\u20101 Main, clotting factor module I: external quality control of diagnostic assays and test (ECAT)","author":"ECAT","year":"2016","journal-title":"Foundation"},{"issue":"1","key":"e_1_2_10_23_1","first-page":"843","article-title":"Validation of the factor IX one\u2010satge APTT clot assay calibrated with pooled normal plasma for the measurement of N9\u2010GP in patients plasma. 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