Evaluation of screening kits for the detection of anti-human immunodeficiency virus type 1 and 2 (HIV-1/2) antibodies.

Abstract

HIV-1/HIV-2 3rd generation (Abbott), Wellcozyme HIV 1 + 2 (Murex), Enzygnost Anti-HIV 1/-HIV 2 (Behring), and Genelavia Mixt (Sanofi Diagnostics Pasteur) are currently registered by authorities as enzyme immunoassays (EIAs) for detecting HIV-1/2 infection. The present study dissects these reagents by means of the major antigenic components, assay principles and their actual performance. The performances have been evaluated by their test results in international panels of seroconversion, mixed titer performance and HIV-1/2 combination, respectively. Those EIA tests were further used to examine 26 potentially false-reacting samples, serial diluted sera prepared from two confirmed positive specimens and 720 specimens obtained from random blood donors in the Taipei Blood Center, Chinese Blood Services Foundation (CBSF). The results showed that, although standard sera of the mixed titer, performance and HIV-1/2 combination rows could not distinguish significantly among various EIAs, the seroconverting samples clearly showed their differences. The differences, as calculated by using 3 of 4 seroconverting sera, was a backward window period ranging from 19 to 23 days as compared to the detection of HIV-1 antigens. Together, these studies strongly suggest that assays which are capable of detecting HIV-specific IgM and IgG antibodies have a shorter seroconversion window. Furthermore, the HIV-2 antigen seems to be crucial for successful detection of anti-HIV-2. Finally, testing anti-HIV-1/2 in the routine screenings is expected not to increase the exclusion rate of blood units currently acquired from the examination of anti-HIV-1. Consequently, with both HIV-1/2 specificities and the ability of early detection, IgM/IgG-captured EIAs may represent a better screening method than assays based solely on the detection of HIV-specific IgG.