This do-it-yourself HIV test kit will give individuals results in about 30 minutes
The Food and Drug Administration announced this week that it has approved the OraQuick In-Home HIV Test kit. The test will be sold over the counter to consumers and is a re-packaging of the same antibody test used by health care professionals. It can detect antibodies to both HIV-1 and HIV-2.
The FDA believes this home test could identify up to 45,000 new diagnoses and prevent nearly 4,000 new infections each year.
The test should be available in stores by October this year. The price is not known at this time.
To use it, individuals swab their upper and lower gums to collect oral fluid and then place the swab in a solution. After 20â€“40 minutes, one of two marks appears: one visible line means the test is negative while two lines mean it is positive. All positive results need to be confirmed by a blood test done by a medical provider.
When done in the home, the test is about 92% accurate at finding everyone who is HIV-positive. The test is nearly 100% accurate at detecting anyone who is HIV-negative, excluding recent transmissions within the previous three months of the test (the window period during which antibodies develop).
One concern with the test is its 92% accuracy rate for HIV-positive results. What this potentially means is that it could miss 1 out of 12 people who are truly positive. One way to avoid this is by following the test instructions.
Another concern is how an individual interprets his or her negative test result, as a negative result is only as good as the window period before it. For those who were infected just two weeks before taking the test, the negative result is “inaccurate.” These individuals should retest as needed.
While acknowledging the concerns above, Project Inform applauds the approval. “Despite these concerns,” says Alan McCord, Director of Education, “the availability of this in-home kit represents more access to HIV testing — a significant part of the 2010 Presidential National HIV/AIDS Strategy.Â Nearly 240,000 Americans do not know they’re HIV-positive, due in part to the fear of being tested in a public setting. This test offers more privacy as well as referral to resources for those who test positive,” McCord said.
OraSure, the company that makes OraQuick, says it will provide ample instructions on how to accurately use the test, interpret the results and access support services, along with a 24-hour support line.