By DONALD G. McNEIL Jr.
Published: July 3, 2012
After decades of controversy, the Food and Drug Administration approved a new H.I.V. test on Tuesday 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 an H.I.V. test as easy to use as a home-pregnancy kit is yet another step in the normalization of a disease that was 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 required a user to prick a finger and mail a drop of dried blood to a lab.
Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a “positive step forward” and one that could help bring the 30-year-old epidemic under control.
Getting an infected person onto antiretroviral drugs lowers by as much as 96 percent the chance that he or she will transmit the virus to someone else, so testing and treatment have become 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 estimates, and about 50,000 more get infected each year.
Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval “wonderful because it will get more people into care.”
The idea of a home test has long been mired in controversy. The first application for one was made in 1987, and the F.D.A. has been considering OraSure’s simple mouth-swab test since 2005.
But the history of AIDS and the human immunodeficiency virus that causes it are unique. AIDS emerged in the 1980s wrapped in a shroud of stigma. It was spread by sex, drug injections and blood transfusions. Along with hemophiliacs, heroin users and Haitians, the most vocal group of early victims was gay men, who were then in the throes of a loud and defiant liberation movement.