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Comparative Evaluation of Rapid HIV Antibody Tests

Chen, Li-Sheng PhD; Babic, Nikolina PhD; Yao, Joseph D.C. MD; Karon, Brad S. MD, PhD

Point of Care: The Journal of Near-Patient Testing & Technology: June 2007 - Volume 6 - Issue 2 - p 109-111
doi: 10.1097/01.poc.0000271407.45430.fd
Original Articles

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.

From the Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, Minnesota.

The study findings were presented in part at the American Association for Clinical Chemistry Annual Meeting in July 2005 (Abstract E-141).

Reprints: Brad S. Karon, MD, PhD, Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail:

© 2007 Lippincott Williams & Wilkins, Inc.