False-Positive Results on Rapid HIV-Antibody Tests

Counselors at several HIV testing programs have reported a higher-than-expected rate of false-positive results with the OraQuick oral fluid test. The CDC, FDA, and test manufacturer are investigating.

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 involves a screening ELISA and, if this is positive, a confirmatory Western blot. The published specificity for the OraQuick oral-fluid test — that is, the likelihood that a person without HIV will have a negative test…

Reviewing Author

Paul E. Sax, MD

False-Positive Results on Rapid HIV-Antibody Tests

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Reviewing Author