Clinical specificity and sensitivity of a blood screening assay for detection of HIV‐1 and HCV RNA

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Abstract
BACKGROUND: An HIV‐1 and HCV NAT blood screening assay (Procleix HIV‐1/HCV, Gen‐Probe, Inc.) simultaneously detecting HIV‐1 and HCV RNA) has been implemented. Donor plasma samples reactive in the Procleix HIV‐1/HCV assay are tested with the HIV‐1 and HCV discriminatory assays to resolve whether HIV‐1 RNA, HCV RNA, or both are present. STUDY DESIGN AND METHODS: To determine the specificity of the Procleix HIV‐1/HCV assay, data were analyzed for samples from 192,288 donations, tested in 16‐member pools. To determine sensitivity, data were analyzed for 2014 commercial samples known to contain HIV‐1, HCV, or both, as well as 10 HIV‐1 and 10 HCV commercial seroconversion panels. RESULTS: The specificity of the Procleix HIV‐1/HCV assay was 99.7 percent. The HIV‐1 and HCV discriminatory assays showed similar specificity. The sensitivity of the Procleix HIV‐1/ HCV assay was 99.9, 99.6, and 100 percent, respectively, for samples containing HIV‐1, HCV, or both. The Procleix discriminatory assays were comparably sensitive. The Procleix discriminatory assays detected all tested samples of known HIV‐1 subtype or HCV genotype. Procleix HIV‐1/HCV testing of seroconversion panels showed that the median times to a positive reaction for HIV‐1 and HCV were reduced by 3 and 25 days, respectively, compared to serologic tests. CONCLUSION: These studies support the use of the Procleix HIV‐1/HCV assay for routine blood donor screening.

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