False-Negative Rapid-Test Results in Early HIV Infection

During the past several years, the FDA has approved at least four rapid antibody tests for HIV infection. Although concerns have been raised about the possibility of false-positive results (ACC Mar 15 2006), these tests are generally considered to be as accurate as enzyme immunoassays (EIAs). Now, however, researchers describe three individuals whose early HIV infections were missed by the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc.).

At the time of the rapid tests, all three patients had detectable HIV viral loads, positive or weakly positive EIAs, and Western blots with bands at p24, p51 or 55, and gp160. However, none of them had positive p41 bands at initial presentation, and their OraQuick tests were falsely negative.…