The U.S. Food and Drug Administration has approved the first over-the-counter HIV test, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes.
The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes.
"The good news here is that someone can do this at home. It's confidential. They don't have to worry about the results being transmitted to anyone else. And I think that tends to be a barrier and prevents some people from getting tested," said Dr. Joette Giovinco, FOX 13's medical reporter.
Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
The FDA says the over-the-counter test is aimed at people who might not otherwise get tested. Doctors hope it will lead to earlier treatment and help prevent the disease from spreading.
Some advocates hailed the new availability of the test.
"This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to," said Tom Donohue, founding director of Who's Positive.
Others say it's not such a good idea.
"While we are very happy people want to know their status, we don't recommend you do it at home," said Jeronica Byrd, with Tampa's Metro Wellness Center.
Byrd says it's what happens after the test that has mental health counselors and caseworkers concerned. They predict that many people won't be prepared for the results.
"That's what we worry about. Because there's denial, anger, fear. The gamut," Byrd said.
In just the last three months, the Metro Wellness Center has tested nearly a thousand people.
Here, she says they can get the kind of support they need—something they may not have at home.
"They're not going to have someone to talk to who knows about this disease, that knows the ins and outs of the system, and what to expect. They're at home alone in their bedroom or bathroom," Byrd said.
FDA stressed in its approval announcement that the test is not 100 percent accurate.
A trial conducted by Orasure showed the home test correctly detected HIV in those carrying the virus only 92 percent of the time. That means the test could miss one person for every 12 HIV-infected people who use the kit.
The test was accurate 99 percent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested.
"There's an increased number of people who will have a false negative result. That means for every 12 people who test, one of those people will get a negative result even though they're truly positive," Giovinco said.
However, Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2002. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.
While it's not clear why the test appears less accurate in consumer trials, company researchers said they expected the test's specificity to drop when used by consumers versus professionals.
In any case, people who test negative should get re-tested after three months because it can take several weeks for detectable antibodies to HIV to appear, experts say.
The OraSure test will be sold at places like Walgreens, CVS and Walmart by the end of October.
Whereas the test marketed to health professionals costs about $17.50, Orasure expects the consumer version to sell for more. The company is not announcing a price yet, but said it would be less than $60.
CEO Doug Michels said the additional cost will help pay for a toll-free call center to provide counseling and medical referrals to test users.
FOX 13 / WTVT-TV
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