Quick At-Home H.I.V. Test Wins Federal Approval
By DONALD G. McNEIL Jr.
A new H.I.V. test for home use that gives quick results was approved on Tuesday by the Food and Drug Administration, giving Americans the first chance in the epidemic’s 30 years to learn in the privacy of their own homes whether they are infected.
The test, made by OraSure and called OraQuick, uses a cheek swab and gives results in 20 to 40 minutes, so it is as easy to use as a home pregnancy kit.
A previous over-the-counter H.I.V. test kit allowed users to prick their own fingers, but the samples had to be mailed to a lab.
Dr. Anthony S. Fauci, the longtime AIDS researcher who heads the National Institute of Allergy and Infectious Diseases, called the OraQuick test a “positive step forward.”
Each year about 50,000 Americans become infected with the human immunodeficiency virus, and about a fifth of the 1.2 million Americans who are now infected do not know it, the Centers for Disease Control and Prevention estimates. Getting an infected person onto antiretroviral drugs early lowers by as much as 96 percent the chances that he or she will pass the virus on to someone else, studies have shown, so treatment has become a form of prevention that could shrink the epidemic.
“If this enhances the number of people you can get into care, the advantages outweigh any objections,” Dr. Fauci said in an interview.
Testing for AIDS has been more fraught with controversy than testing for any other disease because of the unique history of the epidemic. It emerged in the 1980s wrapped in a shroud of stigma because it was mysterious, was transmitted through sex, drug injection and blood transfusions, was inevitably fatal, and often afflicted gay men and drug abusers. —
Being tested for AIDS was seen as tantamount to a public disclosure that one was homosexual or a drug addict, so maintaining privacy became paramount and some gay rights groups warned men to avoid testing.
Tests for flu and cholesterol long ago became routine parts of medical care. Pregnancy kits allowed testing in one’s own bathroom. And tests even for heavily stigmatized sexually transmitted diseases like syphilis were once routine in applying for a marriage license. But testing anyone for AIDS in most states required a separate counseling session and often a signed consent form — all of which added to the air of dread.
Even when lifesaving antiretroviral drugs emerged in the 1990s, states were slow to rewrite laws governing testing, and medical associations took years before suggesting that AIDS tests become part of routine care. The F.D.A. has been considering versions of the home test since 2005.
The new kit will allow anyone who suspects he or she is infected to test in privacy.
Some objections have been raised. When used by average consumers, rather than by health care professionals, the test is accurate 99.98 percent of the time for people who are not infected, but only 92 percent of the time for people who are H.I.V.-positive.
That means about one infected person in 12 would get a false negative, but only about 1 in 5,000 uninfected people would get a false positive.
Any positive test needs confirmation in a doctor’s office, the F.D.A. said. It approved the test not to replace medical testing but because many Americans never get tested at all. The hope is that the home test will encourage infected people to seek medical care earlier, helping save lives and slow the spread of the epidemic.
The home kit “provides another option for individuals to get tested,” said Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the F.D.A.
In the past, some advocates have opposed home testing on various grounds: that finding out one is infected is so stressful that it should be done only in the presence of a counselor, that the uncertainty around the test would be stressful, and that getting a false negative could encourage someone to have unprotected sex.
But since the disease is no longer an inevitable death sentence and it is clear from the epidemic’s continuing spread that Americans are having unprotected sex anyway, those objections began to pale.