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

AIDS. 2006 Aug 1;20(12):1655-60. doi: 10.1097/01.aids.0000238412.75324.82.

Abstract

Objective: 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.

Design: 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.

Methods: 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.

Results: 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%).

Conclusions: 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.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Serodiagnosis / methods*
  • Blotting, Western / methods
  • Enzyme-Linked Immunosorbent Assay / methods
  • Female
  • HIV Antibodies / analysis
  • HIV Infections / diagnosis*
  • HIV Infections / immunology
  • HIV-1 / immunology
  • HIV-2 / immunology
  • Humans
  • Predictive Value of Tests
  • Pregnancy
  • Reagent Kits, Diagnostic
  • Saliva / immunology
  • Saliva / virology*
  • Sensitivity and Specificity

Substances

  • HIV Antibodies
  • Reagent Kits, Diagnostic