NOTE: FDA Cleared-Medical Offices Only-Not Approved For Home Use!
The OraQuick® Rapid HIV-1 Antibody Test:
-A rapid, point-of-care test designed to detect antibodies to HIV-1 within 20 minutes.
-The OraQuick® Rapid HIV-1 Antibody Test has been CLIA (Clinical Laboratory Improvements Amendments of 1988) waived by the the U.S. Food and Drug Administration.
-Based on the results from a large controlled clinical trial, the overall sensitivity and specificity of the OraQuick® Rapid HIV-1 Antibody test was shown to be 99.6% and 100.0% respectively, using fingerstick and venipuncture whole blood specimens.
HIV Counseling and Testing Sites
Community Health Centers
Drug Treatment Centers
Managed Care Organizations