The OraQuick test, by OraSure Technologies, uses a mouth swab and gives results in 20 to 40 minutes.
After decades of controversy, the Food and Drug Administration on Tuesday approved a new HIV test that for the first time makes it possible for Americans to learn in the privacy of their homes whether they are infected.
The availability of a test as easy to use as a home-pregnancy kit for the virus that causes AIDS is another step in the normalization of a disease once seen as a mark of shame and a death sentence.
The OraQuick test, by OraSure Technologies, uses a mouth swab and gives results in 20 to 40 minutes. A previous test sold over the counter had users prick their own finger and mail a drop of dried blood to a lab.
Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first U.S. blood test for the virus in 1984, called the FDA approval “wonderful because it will get more people into care.”
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Getting an infected person onto antiretroviral drugs lowers by as much as 96 percent the chance the patient will transmit the virus to someone else, so testing and treatment are crucial to prevention.
About 20 percent of the 1.2 million infected Americans do not know they have the disease, the Centers for Disease Control and Prevention (CDC) estimates, and about 50,000 more get infected each year.
A home test has long been mired in controversy. The first application for one was submitted in 1987, and the FDA has been considering OraSure’s simple mouth swab since 2005.
AIDS emerged in the 1980s spread by sex, drug injection and blood transfusions. Along with hemophiliacs, heroin users and Haitians, the most vocal group of early victims was gay men.
Because merely being tested for the virus was seen as tantamount to being publicly revealed as a homosexual or a drug addict, and because a positive result was a death sentence, groups like the Gay Men’s Health Crisis advised their members and readers to shun testing until ironclad guarantees of anonymity were put in place.
Alarmists predicted a wave of suicides if home tests were made available. At hearings, AIDS activists handed out copies of an obituary of a San Francisco man who jumped off the Golden Gate Bridge after learning he was infected.
CDC officials warned their FDA counterparts that home testing could lead to a surge of patients that would swamp overburdened health clinics, according to an FDA document.
Even when antiretroviral drugs emerged in the mid-1990s, states were slow to rewrite laws governing testing.
Mark Harrington, policy director for the Treatment Action Group, an AIDS activist organization, said he thought such fears were “a thing of the past” now that it is clear early treatment saves lives.
The new test has some drawbacks.
While it is extremely accurate when administered by medical professionals, it is less so when used by consumers.
Researchers found the home test accurate 99.98 percent of the time for people who do not have the virus, but only 92 percent of the time in detecting people who do.
One concern is the “window period” between the time someone gets the virus and begins to develop the antibodies to it, which the test detects. That can take up to three months.
So, while only about one person in 5,000 would get a false negative test, about one person in 12 could get a false positive.
Any positive test needs confirmation in a doctor’s office, the FDA said, and people engaged in high-risk sex should test themselves regularly.
The agency does not intend for the home test to replace medical testing but instead to provide another way for people to find out their HIV status, said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
It should be available in 30,000 pharmacies and grocery stores and online by October, said Douglas Michels, OraSure’s chief executive.
The price has not yet been set. But Michels said it will be higher than the $17.50 charged to medical professionals because the company will do more complicated packaging for the home kit, open a 24-hour question line and advertise to high-risk groups, including gay men, blacks and Hispanics and sexually active adults.
Still, he said, it will be kept inexpensive enough to appeal to people who might want to buy several a year.
Because the FDA approved it only for people ages 17 and above, retail stores may ask youthful-looking people to show identification to buy it, Michels said.
The restriction is not for medical reasons, but only a few subjects ages 14 to 16 were tested, he said, “so that was the deal we worked out with the FDA.”
Whether having to show identification would deter teenagers or young-looking people from buying a test is unclear. Harrington said he thought it might.
In contrast, teenage girls are not legally required to show identification to buy pregnancy tests.