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Impact of a product‐specific reference standard for the measurement of a PEG ylated rFVIII activity: the Swiss Multicentre Field Study
Author(s) -
Bulla O.,
Poncet A.,
Alberio L.,
ASMIS L. M.,
Gähler A.,
Graf L.,
Nagler M.,
Studt J.D.,
Tsakiris D. A.,
Fontana P.
Publication year - 2017
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/hae.13250
Subject(s) - reference values , reference range , medicine , product (mathematics) , mathematics , geometry
Measuring factor VIII ( FVIII ) activity can be challenging when it has been modified, such as when FVIII is pegylated to increase its circulating half‐life. Use of a product‐specific reference standard may help avoid this issue. Aim Evaluate the impact of using a product‐specific reference standard for measuring the FVIII activity of BAX 855 – a pegylated FVIII – in eight of Switzerland's main laboratories. Methods Factor VIII‐deficient plasma, spiked with five different concentrations of BAX 855, plus a control FVIII sample, was sent to the participating laboratories. They measured FVIII activity by using either with a one‐stage ( OSA ) or the chromogenic assay ( CA ) against their local or a product‐specific reference standard. Results When using a local reference standard, there was an overestimation of BAX 855 activity compared to the target concentrations, both with the OSA and CA . The use of a product‐specific reference standard reduced this effect: mean recovery ranged from 127.7% to 213.5% using the OSA with local reference standards, compared to 110% to 183.8% with a product‐specific reference standard, and from 146.3% to 182.4% using the CA with local reference standards compared to 72.7% to 103.7% with a product‐specific reference standard. Conclusion In this in vitro study, the type of reference standard had a major impact on the measurement of BAX 855 activity. Evaluation was more accurate and precise when using a product‐specific reference standard.