Approval of a new rapid test for HIV antibody

On November 7, 2002, the Food and Drug Administration announced approval of the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) for use by trained personnel as a point-of-care test to aid in the diagnosis of infection with human immunodeficiency virus type 1 (HIV-1). OraQuick is a simple, rapid test that can detect antibodies to HIV in fingerstick whole blood specimens and provide results in as little as 20 minutes [corrected]. The test has been categorized as moderate complexity under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A second FDA-approved moderate-complexity rapid HIV test, Single Use Diagnostic System for HIV-1 (Abbott-Murex Inc., Norcross, Georgia), remains available in the United States for use with serum or plasma specimens.