Background: The number of transfusion-transmitted infections with HIV-1 and HCV has significantly decreased by careful donor selection and the introduction of serological assays. Nucleic acid techniques (NAT) have further contributed to minimize the residual risk of transfusion-borne infections. Here we describe our first year experience in routinely screening blood donations using a multiplex HIV-1/HCV NAT test system. Material and Methods: Since July 2002 the Stuttgart blood bank has utilized the Procleix HIV-1/HCV assay, which simultaneously detects HIV-1 and HCV by means of transcription-mediated amplification (TMA). The HIV-1/HCV TMA assay was carried out on plasma pools each containing a maximum of 8 single blood donations. Results: 5,615 plasma pools (41,830 blood donations) comprising 204 HIV-1/HCV TMA runs were tested. The rate of invalid runs was 1.5%. Invalid pools occurred at a rate of 0.5% and initially reactive pools at a rate of 0.1%, which were not confirmed by repeated testing. Failures turned out to be related to handling errors, insufficient mixing of reagents, and test equipment malfunctions. In order to assess the analytical sensitivity of the TMA assay, we used dilution series based on WHO international standards of HIV-1 and HCV. Probit regression analysis on the 95% level revealed an analytical sensitivity of 16.2 IU/ml for HIV-1 and 3.5 IU/ml for HCV. Conclusion: The Procleix HIV-1/HCV TMA assay represents a highly sensitive diagnostic tool and will contribute to the improvement of virus safety for blood products.
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