Multicenter performance evaluation of a transcription‐mediated amplification assay for screening of human immunodeficiency virus‐1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in blood donations

Abstract

The performance characteristics of Procleix Ultrio assay and the Procleix HIV-1 and HCV assay are comparable. The sensitivity for HIV-1 and HCV met the directives of the Paul-Ehrlich Institute and the FDA. The assay can reduce the WP for HBV by 6 days to 2 weeks when used in small MP (<1:8) or single-donation screening protocols.