A rapid review of rapid HIV antibody tests

Rapid HIV antibody tests recently approved by the Food and Drug Administration can help reduce unrecognized infections by improving access to testing in both clinical and nonclinical settings and increase the proportion of those tested who learn their results. Four rapid HIV antibody tests are now available in the United States; two are approved for use at point-of-care sites outside a traditional laboratory. All four tests are interpreted visually. Sites offering rapid HIV testing must periodically run external controls (known HIV-positive and HIV-negative specimens) and provide persons who undergo rapid testing a subject information sheet. This paper reviews the operating and performance characteristics, quality assurance and laboratory requirements, and HIV counseling implications of the currently available rapid HIV tests.