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News From the Centers for Disease Control and Prevention
December 18, 2002

Approval of a New Rapid Test for HIV Antibody

JAMA. 2002;288(23):2960. doi:10.1001/jama.288.23.2960

MMWR. 2002;51:1051-1052

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 ≤20 minutes. 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.