First ever in-home, self administered HIV test (OraQuick) FDA approved

Knowledge is power and the FDA approved the first ever in-home, self administered HIV test today. The test is called OraQuick and it is made by OraSure Technologies. This is the first-ever in-home HIV test and it was designed to let every day people without a medical background self administer the test (which checks for antibodies to the human immunodeficiency virus type one and type two). HIV is the virus that damages the immune system and causes AIDS (acquired immune deficiency syndrome).

What happens is that the OraQuick test lets you collect a mouth fluid sample by swabbing the upper and lower gums inside the mouth. You then place the sample in a developer vial and the results can be looked at in 20-40 minutes. A positive test does NOT mean that the person is definately infected with HIV, but it does mean that additional testing in a medical setting is needed to confirm the test result. A negative test does NOT mean that someone is absolutely free of HIV (especially if you were exposed to HIV within the last 3 months), but results can help identify large numbers of previously undiagnosed HIV infections.

Importantly, the Centers for Disease Control (CDC) estimates that roughly 1.2 million people are living with HIV infection. The frightening part of this epidemic is that current estimates hold that one in 5 people who are HIV positive (infected with HIV) do not know that they have it. The test appears to be 92 percent sensitive (one false negative result could happen out of every 12 tests). Importantly, the test is 99.98 percent specific for HIV. This means that one false positive result could happen out of every 5,000 tests.

Because testing and results and meanings could be confusing, the maker of the test (OraSure Technologies) will have a consumer phone support center that will be open 24 hours a day, seven days a week to educate users abot HIV/AIDS, how to take the test correctly and guidance on what to do once you get the results.

More about the test is available from the fda at