Washington – The Food and Drug Administration has approved the first rapid, over-the-counter HIV test, which allows Americans to test themselves in the privacy of their homes for the virus that causes AIDS.
The OraQuick test detects the presence of HIV antibodies using a mouth swab and returns a result in 20 to 40 minutes.
Government officials estimate that about 240,000 people, or one-fifth of the roughly 1.2 million people carrying HIV in the U.S., don't know they are infected. Testing is a chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
FDA officials said the test is designed for people who might not otherwise get tested.
"The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.
Orasure plans to start selling the test in October, both online and through retailers like Walgreens, CVS and Walmart. It hasn't set a price yet but expects the consumer version to cost less than $60 but more than the one marketed to health professionals, which costs about $17.50. CEO Doug Michels said the price increase will help pay for a toll-free call center to provide counseling and medical referrals to test users.
The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.
- Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research
"Each of the call-center operators is bilingual in English and Spanish, they've gone through 160 hours of training on HIV counseling and testing," Michels said in an interview with the Associated Press. "So they are highly trained professionals and they'll be there to support the consumer."
Michels said the company's marketing efforts will focus on populations at greatest risk of being infected with HIV, including gay and bisexual men, African Americans and Hispanics.
FDA stressed in its approval announcement that the test is not 100 percent accurate in identifying people with the virus. A trial conducted by test maker Orasure showed OraQuick detected HIV in those carrying the virus only 92 percent of the time, though it was 99.9 percent accurate in ruling out HIV in patients not carrying the virus.
That means the test could miss one in 12 HIV-infected people who use it but would incorrectly identify only one patient as having HIV for every 5,000 HIV-negative people tested, the FDA said.
People who test negative should get re-tested after three months, because it can take several weeks for detectable antibodies to HIV to appear, according to Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention's HIV unit.
The FDA has approved several other HIV test kits designed for home use, but they usually require a blood sample that must be sent to a laboratory for development.
HIV awareness groups hailed the approval as an important step in expanding testing for the virus.
"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.
Experts say it's difficult to predict how widely the test will be used.
According to the Orasure's study, 41 percent of people who discovered they were HIV-positive using OraQuick had never been tested. The company estimates that 9,000 new HIV carriers would be identified for every 1 million people who use the test.
Based in Bethlehem, Pa., 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. It's not clear why the test is less accurate in consumer trials, but researchers said they expected its sensitivity to drop when it was used by consumers.
HIV eventually develops into AIDS, unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which become fatal.
Shares of Orasure Technologies rose 60 cents, or 5.2 percent, to close at $12.10 on Tuesday.