CLIA Waiver granted to OraQuick ADVANCE Rapid HI V-1/2 Antibody Test

FDA granted a CLIA (Clinical Laboratory Improvements Amendments of 1988] waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid on June 25, 2004.

The OraQuick ADVANCE Rapid HIV Test is a fast and non-invasive test approved on March 26, 2004, to detect antibodies to HIV-1 in oral fluid. The oral fluid indication was extended by FDA to include detection of antibodies to HIV-2 in oral fluid on June 22, 2004.

Originally, use of OraQuick ADVANCE Rapid HIV test to detect antibodies to HIV in oral fluid had been limited to certified laboratories (high and moderate complexity laboratories under CLIA). However, as a result of the waiver from the requirements of CLIA, all clinical laboratories certified through CLIA (high, moderate, and waived) can now use this test. The CLIA waiver allows the test to be used under less stringent controls, which is expected to have a major impact on increased access to HIV testing.

The CLIA waiver will allow the rapid oral fluid test to be used in more health care settings, such as doctors’ offices, clinics, and some mobile labs that can offer testing in high-risk areas. Through these venues, testing will be accessible to many more people, particularly to those individuals who are reluctant to be tested due to the need to draw blood.

The test is expected to help diagnose more people earlier, improving their treatment options, and reducing their chance of infecting others. It will also protect health care workers from infection by reducing their exposure to blood.

Manufacturers must submit a request for a CLIA waiver to FDA. To qualify for a waiver, a test must be simple, accurate and present no reasonable risk of harm.

FDA based its waiver decision for the OraQuick ADVANCE Rapid HIV Test on information submitted by the manufacturer, OraSure Technologies, Inc., Bethlehem, PA, demonstrating that the test is simple to run, is very robust under a wide range of environmental stresses, and generates highly accurate results in a wide variety of settings.

The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test provides a highly accurate HIV test result from an easily collected oral fluid sample in as little as 20 minutes, without the need to draw blood. According to data submitted by OraSure and reviewed by the FDA, in limited clinical studies the OraQuick correctly identified at least 99.3% of specimens from HIV-infected persons and at least 99.8% of specimens from uninfected persons.

A reactive result using the OraQuick Rapid HIV-1/2 Antibody Test with oral fluid is considered a preliminary positive result and must be confirmed using an additional, more specific test, such as the Western Blot, just as for testing using blood samples.