Evaluation of commercial enzyme immunoassays for anti-HIV-1 using East African sera.

Sera from 622 blood donors collected in 1986 and 1987 in Tanzania were screened for antibodies to HIV-1 by seven different commercial enzyme-linked immunosorbent assay (ELISA) kits. All ELISA-positive sera were tested by Western blot analysis and many of them also by radioimmunoprecipitation assay (RIPA). Sixty-seven sera were confirmed positive. Eight sera, which were repeatedly positive on only one or two of the ELISA kits and showed weak, doubtful reactions on Western blot and RIPA, were considered indeterminate and were not included in the calculations of sensitivity and specificity of the various ELISA kits. The sensitivity of the ELISAs was as follows: Organon Vironostika: low cut-off 74.6%; Organon Vironostika: high cut-off 62.7%; Du Pont: 85.1%; Pasteur: 78.7%; Abbott: 80.8%; Abbott recombinant: 94.0%; Wellcozyme: 82.1%; Wellcozyme monoclonal: 98.5%. The specificity was as follows: Organon Vironostika: low and high cut-off 100%; Du Pont: 94.7%; Pasteur: 99.3%; Abbott: 100%; Abbott recombinant 98.7%; Wellcozyme: 99.8%; Wellcozyme monoclonal: 98.5%. In conclusion, the two new generation kits tested, Wellcozyme monoclonal and Abbott recombinant, had the highest sensitivity whereas the sensitivity of the first-generation tests was unexpectedly low.