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CLIA Waiver for the OraQuick ® Rapid HIV-1 Antibody Test

CLIA Waiver for the OraQuick ® Rapid HIV-1 Antibody Test. Blood Products Advisory Committee Update March 13, 2003. Elliot P. Cowan, Ph.D. Senior Regulatory Scientist Office of Blood Research and Review Center for Biologics Evaluation and Research Food and Drug Administration.

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CLIA Waiver for the OraQuick ® Rapid HIV-1 Antibody Test

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  1. CLIA Waiver for the OraQuick® Rapid HIV-1 Antibody Test Blood Products Advisory Committee Update March 13, 2003 Elliot P. Cowan, Ph.D. Senior Regulatory Scientist Office of Blood Research and Review Center for Biologics Evaluation and Research Food and Drug Administration

  2. Rapid HIV Test Approval • On November 7, 2002, FDA approved the OraQuick® Rapid HIV-1 Antibody Test as a moderate complexity device under CLIA • Intended use: • To detect antibodies to HIV-1 in fingerstick whole blood specimens • A point-of-care test to aid in the diagnosis of infection with HIV-1 • Suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results

  3. OraQuick® is Approved as a Restricted Device • Sale is restricted to clinical laboratories • that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met; and • where there is assurance that operators will receive and use the instructional materials • Approved for use only by an agent of a clinical laboratory

  4. OraQuick® Restrictions, cont. • Test subjects must receive the “Subject Information” pamphlet prior to specimen collection and appropriate information when test results are provided • Not approved for use to screen blood or tissue donors • Customer letter included with all kits • “By purchasing this device, you are doing so as an agent of a clinical laboratory and agree that you or any of your consignees will abide by the…restrictions on the sale, distribution, and use of the device…”

  5. OraQuick® Clinical Trial Data • Sensitivity in clinical trial: 99.6% (98.5%-99.9%) • Specificity in clinical trial:100% (99.7%-100%)

  6. OraQuick® CLIA Waiver • OraQuick® was granted a CLIA waiver on January 31, 2003 • Data submitted in support of waiver • At 4 sites, 100 lay users with no laboratory experience tested panels of 6 masked randomized specimens • 2 negative, 2 low positive, 2 high positive • No statistically significant difference between lay user results and correct results

  7. OraQuick® CLIA Waiver, cont. • Package insert for waived device in preparation • Will contain details on waiver studies • Sales and use restrictions remain in place for the waived test • Quality Assurance program recommendations for rapid HIV tests are being developed by CDC

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