{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T04:55:00Z","timestamp":1790571300287,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T00:00:00Z","timestamp":1764633600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T00:00:00Z","timestamp":1764633600000},"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":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Accurate monitoring of nonacog beta pegol (N9\u2010GP) is essential to ensure appropriate treatment and to avoid under\u2010 or overdosing, which may result in clinical complications. The product's extended half\u2010life, achieved through molecular modification, poses challenges for activity measurement, particularly when using a one\u2010stage clotting assay (OSA). Therefore, a chromogenic substrate assay (CSA) is preferred, although it may be less practical for urgent or routine monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate OSA and CSA for N9\u2010GP measurement, focusing on the suitability of the OSA STA CK Prest reagent on the STA R MAX analyser.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Factor IX activity (FIX:C) of N9\u2010GP in vitro spiked and post\u2010infusion samples were measured using various OSA reagents and CSA across different analysers. The in vitro sample results were evaluated as percentage recovery; the OSA STA CK Prest results from both spiked and post\u2010infusion samples were compared with those obtained by the CSA Biophen FIX.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Acceptable recoveries for samples spiked at concentrations of 0.04, 0.08, 0.15, 0.61 and 1.22 IU\/mL were achieved using CSA Biophen FIX (mean recovery 92% with the CN 3000 analyser and 108% with the STA R MAX analyser) and OSA STA CK Prest (mean recovery 92%, range 86%\u2013111%). STA CK Prest showed FIX:C results comparable to Biophen FIX in both in vitro and post\u2010infusion samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>STA CK Prest and Biophen FIX showed acceptable recoveries for N9\u2010GP, with FIX:C results in good agreement in both in vitro and post\u2010infusion samples. This supports the reliability of STA CK Prest for FIX:C measurement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70168","type":"journal-article","created":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T12:25:39Z","timestamp":1764678339000},"page":"284-291","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Monitoring of Nonacog Beta Pegol: One\u2010Stage Clotting Assay With Kaolin Reagent as a Practical Alternative to Chromogenic Methods"],"prefix":"10.1111","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-9591-2861","authenticated-orcid":false,"given":"Marie","family":"Prudkov\u00e1","sequence":"first","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"},{"name":"Department of Internal Medicine \u2010 Haematology and Oncology, University Hospital Brno and Faculty of Medicine Masaryk University  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4642-184X","authenticated-orcid":false,"given":"Petr","family":"Smejkal","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"},{"name":"Department of Laboratory Methods, Faculty of Medicine Masaryk University Brno  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dagmar","family":"Chytr\u00e1","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji\u0159ina","family":"Zav\u0159elov\u00e1","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"},{"name":"Department of Laboratory Methods, Faculty of Medicine Masaryk University Brno  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2948-1226","authenticated-orcid":false,"given":"Gabriela","family":"Romanov\u00e1","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miroslav","family":"Penka","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"},{"name":"Department of Internal Medicine \u2010 Haematology and Oncology, University Hospital Brno and Faculty of Medicine Masaryk University  Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alena","family":"Bulikov\u00e1","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology University Hospital Brno  Brno Czech Republic"},{"name":"Department of Internal Medicine \u2010 Haematology and 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