title: Approval of a new rapid test for HIV antibody.
abstract: 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.
mesh_terms: D015492:AIDS Serodiagnosis / Q000295:instrumentation*; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis* / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests
chemical_list: D015483:HIV Antibodies