FDA approves first home HIV test
May 15, 1996
Web posted at: 12:35 a.m. EDT
WASHINGTON (CNN) -- The Food and Drug Administration Tuesday approved the sale of the first home testing kit for the virus that causes AIDS. The kit, which will cost around $40, will be available over the counter in Texas and Florida as early as next month, and sold nationwide by early 1997.
The test, called Confide, will have three components: An over-the-counter home blood collection kit, HIV-1 antibody testing at a certified lab, and a test result center that provides the results and counseling.
All a person has to do is put a blood sample on a pre-coded card, mail it to a lab and call a week later for the results. The procedure allows complete privacy because no names are used, only an identifying number.
If the test is normal, the person gets a recording; if it is positive for the virus, they're automatically connected to a counselor.
But the procedure is not without controversy. Some, such as Reni Vaughn of AID Atlanta, say there is a place for home AIDS testing, but worry about those who will hear they have a life-threatening infection over the phone. Vaughn says face-to-face counseling is critical at such times.
But FDA Deputy Commissioner Mary Pendergast said studies have shown that people can handle receiving such information over the phone. Moreover, she says, callers will be dealing with trained counselors.
"They have good training," Pendergast said of the counselors. "We know that they have been able to handle other serious problems, like suicide or other kinds of hotline prevention programs over the phone."
Public health officials hope home testing will lead to earlier diagnosis and treatment, as well as keep the virus from spreading.
The Centers for Disease Control and Prevention says more than 60 percent of Americans at risk for contracting HIV have not been tested.
The test has been developed and marketed by a subsidiary of Johnson and Johnson and can also be ordered for $50 by dialing 1-800-THE-TEST.
An FDA advisory committee recommended approval of the test last June. The committee concluded the potential benefits of over-the-counter testing kits outweighed potential risks.
CNN Correspondent Dan Rutz contributed to this report
- FDA approves powerful AIDS drug; test for safer blood supply - March 15, 1996
- Deadly HIV holds potential to heal - April 12, 1996
FeedbackSend us your comments.
Selected responses are posted daily.
Copyright © 1996 Cable News Network, Inc.
ALL RIGHTS RESERVED.
External sites are not endorsed by CNN Interactive.