The test, which examines a sample of fluid from the mouth, is approved for free sale in stores and the Internet to people 17 years of age or older.
The FDA wants consumers to know that positive results using the OraQuick test should be confirmed by later laboratory tests. In addition, the test can give a "false negative" for reasons that include the onset of HIV infection within three months before the test. People who have behaviors that expose them to a higher risk of contracting HIV, for example: having unprotected sex with new partners, or injecting illegal drugs, should be tested again on a regular basis. These people should not interpret that a negative result indicates that it is safe to engage in high-risk behaviors.
According to the Centers for Disease Control and Prevention, almost 1.2 million people in the United States live with HIV infection, and about 1 in 5 of these people do not know they are infected, increasing the likelihood of HIV infection. that transmit the infection without knowing it.
Dr. Elliot Cowan, of the Division of Emerging and Transmissible Diseases by Transfusion of the FDA, describes the possible impact of this test and the messages that the FDA wishes to send to consumers.
Q: How do you think the OraQuick approval could impact HIV testing?
A: This test is intended for people who would not otherwise be tested. There is a large group of people who are infected and who do not know it. And even if they are involved in behavior that exposes them to the risk of contracting HIV, they may refuse to visit their doctor or go to a health care institution for a test.
The FDA predicts that the availability of OraQuick, HIV Home Test will contribute to public health to a large extent by helping more infected people know whether or not they are HIV carriers and, as a consequence, reduce HIV transmission.
Since 2002, the FDA has approved a number of rapid tests to detect HIV (tests that do not require special equipment and that provide results in just 20 minutes) that can be used by trained people outside a traditional laboratory or clinic . The OraQuick, Home Test for HIV, provides another option to be tested for HIV to people who want to know if they are HIV carriers.
In addition, in 2013 the FDA approved the first rapid HIV test for the simultaneous detection of the HIV-1p24 antigen, as well as the antibodies against HIV-1 and HIV-2. Antigen detection allows the early detection of HIV-1 infection that is possible with just an antibody test. (HIV-1 is responsible for the majority of HIV infections, HIV-2 is found mainly in West Africa, although cases have been reported in North America and Europe).
Q: How does the test work?
A: The test detects HIV antibodies. You pass a swab through the upper and lower gingiva to obtain a sample of oral fluid with the test device. That device is placed in a tube with a contrast solution. After 20 to 40 minutes, a line will appear if the test is negative. Two lines indicate that HIV antibodies were detected and that you may be HIV positive. Then it will be necessary to perform further tests to confirm this.
Q: So, if it's positive, does that mean I definitely have HIV?
A: Not necessarily. What it means is that further tests are required to confirm your status regarding HIV. Consider this as a first step in the HIV test. No test is perfect and there will be false positives. Clinical studies on self-exams showed that the OraQuick test will produce a false-positive result in one out of every 5,000 tests in uninfected people.
But if you get a positive result, it is very important that you consult your doctor or call the OraQuick Consumer Care Center, which has bilimage advisors available 24 hours a day to answer questions and provide local referrals for testing. later and the treatment.
Q: And if the result is negative, does it mean that I definitely do not have HIV?
A: No, and it is important that the users of the test understand it. The test is not reliable to detect HIV infection until at least three months after infection. In addition, even after three months, false negatives may also appear. Clinical studies conducted with untrained consumers demonstrated that the OraQuick test will produce approximately a false-negative result out of every 12 tests performed on people infected with HIV. It is also important to never interpret a negative result to decide whether you should adopt behaviors that put you at risk of HIV infection.
Q: If there are antibodies in the mouth, does this mean that I can transmit HIV by kissing someone?
A: Antibodies are the body's reaction to the presence of the virus. They are not the virus itself. Body fluids that have been shown to contain high concentrations of the HIV virus are blood, semen, vaginal fluid, breast milk, and other bodily fluids that contain blood. Then, if there is blood in the saliva (for example, due to a cut in the mouth) the saliva could possibly contain enough virus to cause an infection.
Q: What other tests are approved in the US? to get tested for HIV?
A: A complete list of approved HIV tests in the United States . is available on the Vaccines, Blood and Biological Products page at FDA.gov.
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