April 26, 2004
The FDA has approved the OraQuick test for use with oral fluid and for use on plasma specimens. Until now, the test, manufactured by OraSure Technologies, Inc., was approved only for whole blood specimens. This is the first and only rapid HIV test to be approved in the U.S. by the FDA for use with oral fluid.
There is only one test. The primary difference is the type of specimen that can be tested. Until now, the OraQuick rapid HIV test required a whole blood specimen, either from a fingerstick or a tube of blood. The OraQuick test can now be used on oral fluid specimens taken from the mouth.
No. To perform the test, the person being tested for HIV 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 developer 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 in the device.
A reactive HIV test result on oral fluid is a preliminary positive and needs to be confirmed by an additional, more specific test.
In the clinical studies by the manufacturer, the OraQuick oral fluid test correctly identified 99.3% of people who were infected with HIV-1 (sensitivity) and 99.9% of people who were not infected with HIV-1 (specificity). The Food and Drug Administration expects clinical laboratories to obtain similar results.
Right now, the test on oral fluid can be performed only in laboratories. However, the OraQuick rapid HIV test for use on blood was waived under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) in January, 2003, and we have heard that OraSure has been encouraged to submit a request for a CLIA waiver for OraQuick using oral fluid. A waived test can be used in any facility with a CLIA certificate, rather than only in laboratories. As such, a waived test can be used in many more non-clinical settings.
No, the OraQuick test, either for oral fluid or blood specimens, is restricted for use by trained persons. However, if waived, the oral fluid test could be performed in the home setting as a part of partner notification or HIV prevention outreach activities.
If the test receives a CLIA waiver, training requirements will be similar to those for the OraQuick rapid test for blood use. However, because blood is not involved, universal precautions are not necessary.
The test's approval for oral fluids will provide a safe, accurate, and rapid HIV test for persons who don't like to have their finger stuck with a lancet. In addition, healthcare workers face a much lower risk of exposure to infectious diseases from oral fluid than from blood. Contact with saliva has never been proven to result in HIV transmission.
As when used on blood, the OraQuick test device can quickly and reliably detect antibodies to HIV in oral fluid. It can be stored at room temperature, requires no specialized equipment, and takes the same amount of time to process (20 to 40 minutes). It has slightly lower sensitivity and specificity rates than when used with blood.
Although the OraQuick test is approved to detect antibodies to HIV-1 and HIV-2 when used on blood, the FDA's approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1.
No. The OraQuick test should not be used to screen blood donors.