Q. What is the test that uses an oral sample?
A. The oral HIV antibody EIA and the oral HIV antibody Western blot are alternatives to blood testing for HIV-1 antibody. The test can be used on a single oral sample. No needles or skin puncturing are required in any of the steps to detect the presence of HIV-1 antibody. A follow-up HIV antibody EIA for blood is not needed to confirm the results of the oral HIV antibody EIA.
Q. When were these tests approved?
A. On December 23, 1994, the Food and Drug Administration (FDA) approved the OraSure HIV-1 oral specimen collection device, used to collect oral specimens for use with the HIV antibody EIA for oral fluid. On June 3, 1996, FDA also approved the OraSure HIV-1 antibody Western blot kit, which will be used to confirm the presence of HIV-1 antibodies in oral samples that are reactive on screening tests.
Q. Is this test as accurate as the blood tests that have been in use for years?
A. Yes. A correctly performed oral HIV antibody EIA is as accurate as the HIV antibody EIA for blood.
Q. Is the oral sample being collected the same as saliva?
A. No. The oral sample being collected is known as mucosal transudate which comes from the cheek and gums; saliva comes from the salivary glands.
Q. How are HIV antibodies collected from this oral sample?
A. Mucosal transudate contains large amounts of IgG, the type of antibody used to detect HIV. These proteins can pass through the thin lining of the mouth and gums from blood vessels located close to the surface of the mouth. The collection pad, which looks like an ordinary cotton swab, encourages the flow of these proteins, which are then drawn into the pad. This is why the oral HIV antibody EIA gives results that are essentially equivalent to that of a blood test for HIV antibodies.
Q. If you can do an HIV antibody test on an oral sample, then why isn't HIV transmitted by kissing?
A. This test detects HIV antibody, a type of protein present in oral specimens -- not the virus itself. Previous studies have shown that low levels of HIV can be found in oral fluids, especially when visible blood is present. However, no cases of HIV transmission have been clearly attributed to oral fluids.
Q. Who will be able to use this test?
A. The current device is being sold only to physicians and clinics, which may train non-clinicians to collect specimens from patients who consent to testing. Specimens must be processed in a laboratory, as are blood specimens. An oral HIV antibody home test kit may be available to the public in 1997 or 1998.
Q. How are the results of the oral HIV antibody EIA interpreted?
A. Persons who are tested for HIV antibody with this oral test should be given the same considerations as those taking any other HIV test. They must consent to being tested and receive appropriate pre- and post-test counseling. All test results should be kept confidential. A diagnosis of HIV infection can be made with an oral HIV antibody EIA after confirmation with the licensed OraSure oral HIV-1 antibody Western blot kit.
Q. How much will a test cost? Will it be less expensive than a blood test?
A. Prices will be set by the manufacturer of the test kit, the laboratory that performs the test, and the clinician who collects the specimen or orders the test. As with other medical tests, prices are likely to vary widely. However, since the number and types of tests performed on oral fluid samples are the same as those performed on blood, the price ranges may be comparable.