Pathology Patterns Reviews Am J Clin Pathol 2006;126(Suppl 1):S61-S70 S61 DOI: 10.1309/NRYC42PMKCCELBVQ S61 © American Society for Clinical Pathology Abstract The US Food and Drug Administration (FDA) has approved 4 rapid assays for detecting antibodies to HIV using whole blood, serum, plasma, or oral fluid specimens. The HIV antibodies are measured using lateral flow or flow-through immunoassay procedures. No special laboratory instrumentation is needed, and results are interpreted by visual observation in 20 minutes or less. The whole blood and oral fluid assays are waived tests and can be used in a point-of-care setting. The sensitivity and specificity of these HIV assays are similar to those of the standard HIV enzyme immunoassays. Rapid HIV results are required in the labor and delivery setting to help prevent mother-to- child transmission of HIV infection and in the occupational health setting to test the source patient after a needlestick injury. Rapid HIV testing also is used in emergency departments and outpatient clinics to help prevent the spread of HIV by identifying people with otherwise unrecognized HIV infection. If the FDA approves a rapid HIV test for home use, the public would be able to use it in the privacy of their homes, which would encourage more people to know their HIV status. Widespread HIV antibody testing began in 1985 when the US Food and Drug Administration (FDA) approved the first enzyme immunoassay (EIA) method. However, a number of false-positive results were obtained with these early EIAs because of nonspecific reactions between the anti- bodies present in the specimen and the viral lysate antigens that were used to detect the HIV antibodies. A significant improvement in sensitivity and specificity was obtained when synthetic peptide and recombinant antigens replaced the viral lysate as the source of the relevant antigens. The standard laboratory algorithm for detecting HIV infection in the United States consists of screening with an EIA method and confirming a positive EIA result by using a Western blot or immunofluorescent procedure. However, the turnaround time for reporting HIV results with these EIA tests is between 2 and 7 days. Although these EIA tests are well suited for batch screening, they cannot be used for rapid assessment of an individual patient’s HIV status. Recent advances in technology have produced rapid HIV antibody test methods that can provide results in 20 minutes or less. Rapid HIV testing is particularly useful when the result can have an immediate impact on patient outcome, such as in labor and delivery suites, when the HIV status of the mother is unknown, and also when health care workers are accidentally exposed to a needlestick injury or to poten- tially infective body fluids. Rapid HIV testing also can have a significant role in preventing the spread of HIV infection when used in outpatient clinics and emergency departments to detect HIV in people with unknown HIV status. The FDA approved the first rapid HIV antibody test in 2002. Currently, there are 4 FDA-approved rapid tests: the OraQuick Advance HIV 1/2 antibody test (OraSure Tech- nologies, Bethlehem, PA), the Uni-Gold Recombigen HIV-1 Rapid HIV Antibody Testing Methods and Clinical Utilization Michael A. Pesce, PhD, Kar Fai Chow, MD, Eldad Hod, MD, and Steven L. Spitalnik, MD Key Words: Rapid HIV antibody tests; Ease of use; Point of care; HIV prevention DOI: 10.1309/NRYC42PMKCCELBVQ