Algorithms for detecting antibodies to HIV-1: results from a rural Ugandan cohort.

ABSTRACT

OBJECTIVE: To evaluate an algorithm using two enzyme immunoassays (EIA) for anti-HIV-1 antibodies in a rural African population and to assess alternative simplified algorithms. METHODS: Sera obtained from 7895 individuals in a rural population survey were tested using an algorithm based on two different EIA systems Recombigen HIV-1 EIA and Wellcozyme HIV-1 Recombinant. Alternative algorithms were assessed using negative or confirmed positive sera. RESULTS: None of the 227 sera classified as unequivocably negative by the two assays were positive by Western blot. Of 192 sera unequivocably positive by both assays, four were seronegative by Western blot. The possibility of technical error cannot be ruled out in three of these. One of the alternative algorithms assessed classified all borderline or discordant assay results as negative had a specificity of 100% and a sensitivity of 98.4%. The cost of this algorithm is one-third that of the conventional algorithm. CONCLUSIONS: Our evaluation suggests that high specificity and sensitivity can be obtained without using Western blot and at a considerable reduction in cost.

ABSTRACT

PIP Although the Western blot test is widely used to confirm HIV-1 serostatus, concerns over its additional cost have prompted review of the need for supplementary testing and the evaluation of alternative test algorithms. Serostatus tends to be confirmed with this additional test especially when tested individuals will be informed of their serostatus or when results will be used for research purposes. The confirmation procedure has been adopted as a means of securing suitably high levels of specificity and sensitivity. With the goal of exploring potential alternatives to Western blot confirmation, the authors describe the use of parallel testing with a competitive and an indirect enzyme immunoassay with and without supplementary Western blots. Sera were obtained from 7895 people in the rural population survey and tested with an algorithm based on the Recombigen HIV-1 EIA and Wellcozyme HIV-1 Recombinant; alternative algorithms were assessed on negative or confirmed positive sera. None of the 227 sera classified as negative by the 2 assays were positive by Western blot. Of the 192 identified ass positive by both assays, 4 were found to be seronegative with Western blot. The possibility of technical error does, however, exist for 3 of these latter cases. One of the alternative algorithms assessed classified all borderline or discordant assay results as negative with 100% specificity and 98.4% sensitivity. This particular algorithm costs only one-third the price of the conventional algorithm. These results therefore suggest that high specificity and sensitivity may be obtained without using Western blot and at a considerable reduction in cost.