OraQuick ADVANCE Rapid HIV-1 Research Articles

Comparative Evaluation of Rapid HIV Antibody Tests

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.

Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies

To evaluate the performance of a rapid HIV antibody test used with whole blood and oral fluid in settings where the test is likely to be used. In four separate studies, we compared the accuracy of the rapid test performed on whole blood and oral fluid specimens with the results of conventional HIV tests. Oral fluid and whole blood from persons of unknown HIV status recruited from clinics, labor and delivery units, and outreach venues were tested with the OraQuick Advance rapid HIV-1/2 antibody test. Sensitivity and specificity were compared with results of the enzyme immunoassay (EIA) and Western blot algorithm used by the study sites. OraQuick sensitivity was 99.7% with whole blood and 99.1% with oral fluid from 327 persons who were HIV antibody positive by the conventional algorithm. OraQuick specificity was 99.9% with whole blood and 99.6% with oral fluid from 12 010 HIV-negative persons; EIA specificity was 99.7%. A cluster of 16 false-positive oral fluid tests occurred in one study, in which specificity was lower (99.0%) than in the other three studies (99.6-99.8%). In diverse settings in four studies, the OraQuick test showed high sensitivity and specificity for HIV antibody in whole blood and oral fluid specimens. Slightly more false-positive and false-negative results occurred with oral fluid than with whole blood, but performance with both specimen types was similar to, or better than, that of conventional EIAs.

Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing

Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the manufacturer and evaluate quality assurance procedures.

False-Positive Results on Rapid HIV-Antibody Tests

The OraQuick Advance Rapid HIV-1/2 Antibody Test (OraSure Technologies, Bethlehem, Pennsylvania) can be done by trained personnel as a point-of-care test for HIV antibody in oral fluid. These characteristics obviate the need for blood drawing and the use of a central laboratory, and the rapid turnaround allows providers to give negative results to their patients during the same visit (ACC Mar 1 2003). However, reactive tests are considered preliminary and must be confirmed by standard HIV-antibody testing, which in most cases …