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Abstract |
Evaluation of a New Third Generation HIV-1/2 Immunoassay |
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Diagnostic screening assays for the detection of antibodies directed against human immunodeficiency virus type 1 and 2 (HIV-1/2) are important measures to guarantee the safety of blood products. In this study we introduce the third generation Biotest anti-HIV TETRA enzyme-linked immunosorbent assay (ELISA). All 479 anti HIV-I and 200 anti-HIV-2 positive samples tested were clearly detecfed by the TETRA ELISA with a sensitivity of l00%. In 7 out of 19 seroconversion panels the TETRA ELISA was earlier positive than the Biotest second generation assay reducing the diagnostic window by a median value of 8.7 days. All sera representing different HIV subtypes (n=34), including HIV-O samples, reacted maximally positive, whereas 152 potentially cross-reactive sera were completely negative with the Biotest anti-HIV TETRA ELISA. A specifïcity of 99.82% was obtained by testing 8133 blood donors compared with 99.77% observed with a HIV-1/2 third generation plus EIA, which was used as a reference. The Biotest anti-HIV TETRA ELISA showed distinctly improved performance compared to the preceding Biotest HIV ELISA and allows a sensitive and specific detection of anti-HIV antibodies. |
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