At-home HIV testing approved
Now, in as little as 20 minutes, a person can find out if he or she is HIV positive in the privacy of their own home.
Today the U.S. Food and Drug Administration approved the first at-home HIV test kit.
According to the Centers for Disease Control and Prevention, about one in five of the 1.2 million people in the U.S. with HIV are unaware they are infected.
The at-home test is targeted at those who otherwise wouldn’t get tested and could be unknowingly spreading the disease, according to the FDA.
The OraQuick In-Home HIV Test uses oral swabs to determine whether a person is infected. Unlike other at-home tests, the kit doesn’t require sending samples to a laboratory.
Here’s how it works: You swab your upper and lower gums for an oral fluid sample with the test device. The device is then placed in a tube with a developing solution. After 20 to 40 minutes, one line will appear if the test is negative. Two lines indication HIV antibodies were detected.
While the at-home kit can give a positive result, the FDA said the results must be confirmed by follow-up laboratory-based testing.
As with all tests, the in-home HIV test is not perfect.
According to the FDA, clinical studies showed the OraQuick test will produce one false positive result out of about every 5,000 tests in uninfected people.
The test is also not reliable at detecting HIV until at least three months after infection. Even after three months, there can be false negatives, according to the FDA.
Clinical studies showed the test will produce about one false negative out of every 12 tests performed in HIV-infected people, according to the FDA.
The FDA approved the kit for sale in stores and online to anyone 17 years and older.
Orasure, the producer of the test, plans to launch the test in October, selling it through retailers like Walgreens, CVS and Walmart, as well as online pharmacies, according to an Associated Press story.
Orasure has marketed a version of the test to health care providers since 2002. Whereas that test sells for about $17.50, Orasure expects the consumer version to sell for more (less than $60), according to the article.
The additional cost will help pay for a toll-free call center to provide counseling and medical referrals to test users.
The Kaiser Family Foundation recently reported that only about 40 percent of U.S. adults (ages 18-64) report ever being testing for HIV.
Do you think the at-home test will help improve those numbers?