ArticleHaemophilia : the official journal of the World Federation of Hemophilia2025
Factor VIII Activity and Factor VIII Inhibitors Can Be Measured Accurately in Plasma Containing Mim8 by Using Specific Chromogenic Assays.
Article in Haemophilia : the official journal of the World Federation of Hemophilia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionPatients with Haemophilia A treated with Mim8 may require concomitant Factor VIII (FVIII) replacement; hence, accurate assessment of FVIII activity (FVIII:C) and FVIII inhibitors in the presence of Mim8 is important.
aimAssess which chromogenic substrate assays (CSAs) accurately monitor FVIII:C and FVIII inhibitor levels in the presence of Mim8.
methodsFVIII and Mim8 were spiked into congenital FVIII-deficient plasma to obtain mixtures containing various FVIII:C levels (0-100 IU/dL) and Mim8 concentrations (0, 3, 6 and 12 µg/mL). Five CSAs using different activated Factor IX and X sources (bovine, bovine-human or human) were used to measure FVIII:C. Bovine and bovine-human CSAs were then used to measure FVIII:C of standard half-life (SHL) and extended half-life (EHL) FVIII products. FVIII inhibitor levels were assessed using two different bovine CSAs in congenital FVIII-deficient plasma spiked with various Mim8 concentrations (5, 10, 20 and 40 µg/mL) and FVIII inhibitor levels (0.2, 1.0 and 4.8 BU).
resultsHigh levels of interference were observed using human CSAs. Bovine CSAs accurately measured FVIII:C of SHL and EHL FVIII products in the presence of Mim8 without interference. In bovine-human CSAs, interference was observed at 5 IU/dL FVIII, increasing up to four-fold with increasing Mim8 levels. FVIII inhibitor levels were accurately measured using bovine CSAs without Mim8 interference.
conclusionFVIII:C of SHL and EHL products and FVIII inhibitor levels can be accurately monitored in the presence of Mim8 using bovine CSAs at all FVIII levels, and bovine-human CSAs at FVIII concentrations >20 IU/dL.
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