To perform the test, the person being tested for HIV-1 takes the device, which has an exposed absorbent pad at one end, and places the pad above the teeth and against the outer gum. The person then gently swabs completely around the outer gums, both upper and lower, one time around. The tester then takes the device and inserts it into a vial containing a solution. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.
Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional more specific test. The OraQuick test has not been approved to screen blood donors. Although the test is approved to detect antibodies to HIV-1 and -2 when used on blood, today’s approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1.
The OraQuick Rapid HIV-1/2 Antibody test for use on blood was categorized as a waived test under CLIA (Clinical Laboratory Improvements Amendments of 1988) in January, 2003. A waived test system can be given in facilities with any CLIA certificate, rather than only in facilities certified for higher complexity tests. As such, a test categorized as a waived test can be used in many more health care settings by many different health providers.
All new test systems are categorized as high complexity systems until they are submitted for categorization under CLIA.
“I strongly urge the OraSure company to apply for a CLIA waiver for this test using oral fluid samples as well,” said Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D. “If the FDA finds that the company’s data proves that the OraQuick test used with oral fluids is both easy and safe to use in the waived lab setting – as it is with used with blood – then more people will likely be tested for HIV infection. In addition, any risk to healthcare workers of performing the test will be greatly reduced since they will not be exposed to blood.”
The Centers for Disease Control and Prevention (CDC) has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) have worked with state and other health officials to make the test widely available and to offer technical assistance and training for its use.