OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

FDA granted CLIA waiver for the use of oral fluid specimens with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. This is viewed as a major advance in testing for HIV infection. Previously, only blood-derived specimens could be used for testing with minimal oversight.

This document will highlight the key simple points that will explain the CLIA waiver and what it means to have a CLIA waiver for the use of oral fluid specimens with a rapid HIV test.

• The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) set quality standards for all laboratory testing to ensure that patient results are accurate, reliable and are reported in a timely manner, regardless of where the test is performed. A laboratory is any facility that performs testing on human specimens.

• According to CLIA '88, tests that are classified as “moderate complexity” are subject to specific personnel requirements and particular activities are required to assure quality (quality control, quality assurance, proficiency testing). In addition, laboratories certified to run moderate complexity tests are inspected on a regular basis (every other year).

• The requirements for laboratories running CLIA '88 waived tests, on the other hand, are that the laboratory only enroll in CLIA, pay a fee, and follow the manufacturer’s test instructions.

• Tests waived from the requirements of CLIA '88 are tests that the FDA finds so simple and accurate that there is little risk of an incorrect testing result.

• There are nearly 5 times as many laboratories that are certified to run CLIA waived tests as there are to run moderate complexity tests. Therefore, CLIA waiver means that a test will be more widely available.

• The HIV OraQuick Rapid HIV Antibody Test was approved for use with oral fluid samples in March, 2004 and was approved to detect antibodies to HIV-1, the most prevalent form of the virus in the U.S. Until then, all rapid HIV tests required the use of blood to get rapid results.

• On June 22, 2004, FDA approved use of OraQuick to detect antibodies to HIV-2 in oral fluid. The prevalence of HIV-2 in the U.S. is extremely low.

• The same test using blood samples was approved in November, 2002. In January 2003 OraQuick was categorized as a waived test under CLIA '88 (Clinical Laboratory Improvements Amendments of 1988) for use with whole blood specimens. Waived test systems can be used in facilities with any CLIA certificate, rather than only in facilities certified for higher complexity tests. Many different health providers can use a test categorized as a waived test in many more health care settings.

• Today, FDA granted a CLIA waiver to the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid. FDA based this decision on information submitted by the manufacturer, OraSure Technologies, Inc., Bethlehem, Pa. Manufacturers can request a CLIA waiver for their test. To qualify for a waiver, a test must be simple, accurate and present no reasonable risk of harm.

• The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test will give 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.

• The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test actually detects antibodies to both the HIV-1 and HIV-2 viruses. Detection of antibodies to HIV-1 and HIV-2 in oral fluid specimens using the OraQuick rapid test is very accurate. 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, just as for testing using blood samples.

• CDC estimates that 180,000-280,000 people infected with HIV in the U.S. do not know that they are infected, and there are 40,000 new HIV infections in this country each year.

• CLIA waiver for OraQuick oral fluid testing will make HIV testing more readily available to people who need it and should encourage more people to be tested. The CLIA waiver allows the test to be used under less stringent controls. CLIA-waived tests can be performed and interpreted in a physician’s office or other settings without having to be sent out to a special CLIA '88-certified lab.

• The ability to use oral fluid specimens to test for HIV infection means that a barrier to testing is removed for those individuals who are reluctant to be tested due to the need to draw blood. This offers an opportunity to dramatically reduce the number of individuals who not aware of their HIV status, in keeping with the Centers for Disease Control and Prevention’s HIV Prevention Strategic Plan through 2005 .

• The ability to use oral fluid specimens to test for HIV infection means that any potential risk to healthcare workers of performing a test is dramatically reduced since it will not be necessary to handle or use blood for testing (oral fluid has not been demonstrated to transmit HIV infection).

• FDA continues to work with manufacturers to approve more tests and to further expand our arsenal for use against the HIV epidemic.