Thrombogenicity Screening of Factor IX Concentrates

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Abstract
The results of NAPTT and TGt50 assays on concentrates produced during the last 2 yr are presented. A number of products from other centers were also assayed. Analysis of these results shows no correlation between the 2 assays, strongly suggesting that they are measuring different entities. This confirms the results of Pepper et al. who demonstrated that the entities responsible for TGt50 [thrombin generation time] and NAPTT [non-activated partial thromboplastin time] activity are of different sizes and proposed that NAPTT activity, ascribed to a combination of activated factors IX and X, may be a result of TGt50 activity. Demonstration of such a casual relationship requires further characterization of the individual activities, but the rarity of concentrates that have short NAPTTs but long TGt50 is suggestive. This could arise by removal of the TGt50 activity during production, as occurs during polyethylene glycol fractionation of concentrates.

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