Calibration of the 7th British Working Standard for factors II, IX and X, concentrate.

Biologicals

Haemostasis Section, Biotherapeutics Group, National Institute of Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.

Published: November 2018

Seven laboratories from 5 different countries participated in the calibration of the 7th British Working Standard (BWS) for blood coagulation factors II, IX and X. The candidate, 15/182, was assayed for Factors II and X potencies against the 4th International Standard (IS) for Factors II and X, Concentrate (11/126) and for Factor IX potency against the 5th IS for Factor IX, Concentrate (14/148). Intra-laboratory GCVs for all 3 factors were less than 10%, with the majority less than 5%. Inter-laboratory GCVs were 3.4%, 3.2% and 2.3% for FII, IX and X respectively. All participants agreed with the value assigned and preparation 15/182 was established by NIBSC in October 2017 as the 7th BWS for FII, IX, X Concentrate with potencies of 6.0 IU/ampoule, 6.7 IU/ampoule and 4.9 IU/ampoule for FII, IX and X respectively.

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http://dx.doi.org/10.1016/j.biologicals.2018.08.007DOI Listing

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