[Specificity of a new test for detection of antibodies to HIV-1/-2 in blood donors].

Abstract

Background: The aim of the continuous development of anti-HIV-ELISA tests is the improvement of their specificity and sensitivity. With this study the precision and the specificity of the Cobas Core Anti-HIV-1/HIV-2 DAGS, a 3rd-generation anti-HIV assay, were evaluated.

Materials and methods: 1,557 frozen and 1,654 fresh sera from blood donors were tested with the Cobas Core Anti-HIV-1/HIV-2 DAGS (Roche Diagnostic Systems, Basel, Switzerland) and the Abbott Recombinant HIV-1/HIV-2 3rd Generation EIA (Abbott GmbH Diagnostika, Wiesbaden, Germany), which was used as a reference assay. Positive sera were tested with a Westernblot. 34 sera, previously not negative in the Abbott test, were retested with the two anti-HIV assays and with a Westernblot. The intra- and inter-assay precision was evaluated with the positive and negative controls of the test kits and with control sera.

Results: The intra- and inter-assay precision of the Roche test was very good. The specificity of the Roche test is 99.91%. Out of 3,211 tested sera those of three blood donors were false positive in the Roche test and one sample false positive in the Abbott test.

Conclusions: The precision and specificity of the new anti-HIV test fulfil the demands of transfusion medicine.