No infectious disease has ever been detectable by a test that consumers can buy over the counter and get quick results at home. But HIV isn't just any infection. It's a stubborn pandemic virus that's still making people sick and killing them 31 years after it first appeared – even though infection is easily prevented and effectively treated.
The Food and Drug Administration's approval of the OraQuick In-Home HIV Test carries the hope that it can help identify some of the nearly quarter-million Americans infected by HIV who don't know it.
These unknowingly infected people are one reason there are something like 50,000 new HIV infections a year in this country. HIV testing centers haven't been able to make a dent in this persistent problem, because many of those at risk of HIV infection don't seek out testing.
That might be true of home test kits too, of course. But U.S. health officials hope that privacy, convenience and easy access might induce many people to test themselves at home.
There's already an approved home HIV test kit, but it requires consumers to stick a finger to collect a few drops of blood and then send the sample in to a laboratory and wait for results.
Taking the newly approved test will be simple. Consumers are directed to swab their gums, upper and lower, and put the swab into a vial. Twenty to 40 minutes later, if a single horizontal line appears on the front of the vial, the result is negative. Two lines mean the user may have HIV.
But not necessarily. Interpretion of the test gets a little tricky.
One negative out of 12 is actually a false result – the person may actually be infected by HIV but the test didn't pick it up. A positive result is much less likely to be wrong: Only 1 in 5,000 positives are false. But a positive still requires the user to go to a professional lab for re-testing before jumping to the conclusion that he or she actually has HIV.
And then there's the "window" problem. For the first three to six months after becoming infected with HIV, a person hasn't made enough antibodies to be picked up by the test during that window. So people who get a negative result will be advised to take another test a few months later if they have reason to believe they've been exposed to the virus.
Clearly, consumers who buy the OraQuick test kits may have questions – about the test, about what they should do about a result. So the FDA is requiring OraSure, which makes the test, to set up a 24/7/365 hotline staffed by live humans who can answer questions and refer consumers to health professionals in their zip codes for followup care.
These complications explain the muted enthusiasm among some HIV experts toward the new home test.
Dr. Judith Aberg, chair of the HIV Medicine Association, says in a statement that the test "holds great promise as a self-directed tool for people to learn their HIV status."
But she goes on to say that there needs to be more research and education about how the test is used – especially among low-income and minority populations that are disproportionately affected by HIV. For both those who test positive and those who test negative, proper followup is crucial, she says.
Douglas Michels, president and CEO of , told Shots that the company takes seriously the need for consumer guidance. And he predicts that the new test will make a difference in slowing the epidemic.
"For every million people who take the test," Michels says, "we'll identify an additional 5,000 new HIV infections. And through that identification, we will be avoiding more than 700 future transmissions of HIV infection."
Michels says the test will be available around October at most pharmacies, retailers such as WalMart and Kroger, and online.
He declined to say how much test kits will cost. But he said it would be in excess of the $17.50 list price of the version currently used in hospitals, clinics and doctors' offices. That's because of more elaborate packaging, education and customer support.
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