Comparative Evaluation of Rapid HIV Antibody Tests

Abstract

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (OraSure Technologies, Inc, Bethlehem, Pa), Uni-Gold Recombigen HIV (Trinity BioTech PLC, Bray, Ireland), and Multispot HIV-1/HIV-2 Rapid Test (BioRad, Hercules, Calif) are Food and Drug Administration-approved, single-use immunoassays available for the rapid detection of antibodies to HIV. We compared the analytic performance of these HIV antibody tests on plasma specimens. Twenty HIV-1-positive and 50 HIV-1-negative plasma samples were analyzed by the 3 rapid tests according to manufacturers' instructions. Ten enzyme immunoassay-positive but Western blot-negative samples and 20 plasma specimens seropositive for antibodies to other viral agents were also tested to assess cross-reactivity. A semiquantitative scale (0 to 3+) was developed to grade the clarity of the background and visible band lines. For all 3 assays, reproducibility and sensitivity were 100%. Visible bands appeared within 2 to 3 minutes for all HIV-positive sera tested. Except for 1 sample positive for anti-hepatitis B virus later confirmed to be also seropositive for HIV-1, OraQuick and Uni-Gold showed no cross-reactivity with non-HIV antibodies, whereas Multispot gave 1 weak positive result with an anti-hepatitis A virus specimen. Of the 50 HIV-negative plasma samples, all tested negative on OraQuick, whereas Uni-Gold and Multispot yielded 1 and 2 reactive (1+) samples, respectively. All 3 tests showed comparable background clarity for all tested samples. We conclude that all 3 tests are easy to use, are easy to read, and show suitable sensitivity for rapid HIV antibody screening in the point-of-care setting. Positive results from any rapid test should be confirmed by additional laboratory testing.