Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112).

BSP Biological Standardisation Programme FVIII assay discrepancy FX activation Factor VIII chromogenic kit

Journal

Pharmeuropa bio & scientific notes
ISSN: 2075-2504
Titre abrégé: Pharmeur Bio Sci Notes
Pays: France
ID NLM: 101510163

Informations de publication

Date de publication:
2023
Historique:
medline: 6 6 2023
pubmed: 5 6 2023
entrez: 5 6 2023
Statut: ppublish

Résumé

Chromogenic assay discrepancies were reported at General European Official Medicines Control Laboratories Network (GEON) meetings by laboratories testing FVIII-products. The objectives of the present investigation were to carry out a controlled collaborative study to examine these reports and to delineate the reasons for these discrepancies by assessing affected and unaffected FVIII products. The laboratories followed a strict study protocol, which included assessing their own individual observed factor X (FX) activation times, i.e. the time to reach 50% of maximal FX activation (T

Identifiants

pubmed: 37272308

Substances chimiques

Factor VIII 9001-27-8
Chromogenic Compounds 0
Hemostatics 0
Factor X 9001-29-0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1-14

Informations de copyright

© Council of Europe, 2023.

Auteurs

S Raut (S)

National Institute for Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire, EN6 3QG, United Kingdom.

A Daas (A)

European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.

P Rigsby (P)

National Institute for Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire, EN6 3QG, United Kingdom.

A Costanzo (A)

European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.

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Classifications MeSH