FDA Approves OraQuick Rapid Test for HIV-1 in Oral SamplesFDA on Friday approved Bethlehem, Pa.-based OraSure Technologies' OraQuick Rapid HIV-1/2 Test, which uses an oral fluid sample, for use in detecting HIV-1 in oral fluid samples, the Washington Times reports. Other approved rapid HIV tests require a needle prick to acquire a blood sample, a process that can be painful, according to the Times. The newly approved antibody test, which produces results in 20 minutes, requires health care workers to wipe a treated swab along the gums of a patient's mouth, then place the swab into the testing liquid. If one line appears on the swab, the person is 99.8% likely to be HIV-negative. However, if two lines appear on the swab, the person is 99.3% likely to be HIV-positive, although a laboratory test is required to confirm the result (Howard Price, Washington Times, 3/2). OraSure last week announced that it had received FDA approval for its OraQuick Rapid HIV-1/2 test, which simultaneously detects antibodies to HIV-1 and HIV-2 using finger-stick and venipuncture blood samples. The test previously had been approved only for use in detecting HIV-1 in blood samples (Kaiser Daily HIV/AIDS Report, 3/25). The oral test, which can be stored at room temperature and does not require specialized laboratory equipment, is safer for health care workers, who can become infected with HIV through accidental punctures with needles contaminated with the virus. The test initially will be available in about 40,000 medical laboratories nationwide. However, HHS Secretary Tommy Thompson on Friday urged OraSure officials to file a request for a waiver that would allow the test to be used in 180,000 different health settings, including doctors offices, neighborhood clinics and mobile vans. Officials said that the test, which will cost between $12 and $15, eventually may be available as a home test, according to the Times (Washington Times, 3/27).
Officials said that the test could help combat HIV/AIDS by encouraging more people to be tested and receive their test results, according to Reuters/Washington Post. Approximately one-fourth of the estimated 900,000 HIV-positive people in the United States do not know they are infected, according to CDC. Thompson said, "This oral test provides another important option for people who might be afraid of a blood test." People who are administered the standard laboratory test often do not return to receive their results, which usually are available two weeks after testing (Reuters/Washington Post, 3/27). "It's extraordinary how many people don't come back for follow-up when they have to wait two weeks," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said, adding that the new test is "a very good thing" (McNeil, New York Times, 3/27). AIDS Project Los Angeles Executive Director Craig Thompson said that approval of the oral test "may be one of the biggest HIV stories of 2004." He added, "This much anticipated addition to available options for HIV antibody testing means we have a truly convenient, non-invasive and rapid test" (APLA release, 3/28).