A recombinant protein based immunoassay for the combined detection of antibodies to HIV-1, HIV-2 and HTLV-I.

The aim of this study was to develop and evaluate a combined assay for the detection of antibodies to HIV-1, HIV-2 and HTLV-I (human T-cell leukemia virus type I). A mixture of recombinant proteins and synthetic peptides was fixed to the surface of microELISA wells and a protein A peroxidase conjugate was used as tracer. The combined assay was compared to specific HIV-1/2 and HTLV-I commercial ELISAs. The sensitivity was studied with a panel of 158 HIV-1, 82 HIV-2 and 48 HTLV-I positive sera, all of which were reactive in the combined assay. The analytical sensitivity was studied with a panel of serially diluted sera and was similar to that obtained for the specific ELISAs. The specificity of the test was 99.78% against a panel of 466 negative sera collected from voluntary donors that included HBsAg, HCV, and VDRL positive sera. The false positive serum was borderline in the HTLV-I specific ELISA. The new combined ELISA can be used as an efficient initial screening assay, avoiding the cost of individual tests for HIV and HTLV.