Now under debate: whether such at-home projects should include testing for HIV/AIDS, via a kit available over the counter.
A rapid results test manufactured by Pennsylvania-based OraSure Technologies has been widely used by doctors and health clinics since its approval by the Federal Drug Administration three years ago.
The FDA's Blood Products Advisory Committee began discussing Thursday whether to recommend the approval of OraSure's kit for public use, with panelists focusing on the test's packaging, instructions and the practical details of its use.
The ease and privacy offered by a home HIV test are countered by health officials' concerns that people may discover they have contracted HIV while home alone, without immediate access to counseling or medical care.
"When people find out their results, they can be suicidal and upset, said Rebecca Frongberg, HIV counseling and testing coordinator for the Utah Department of Health. "If they do not have adequate or accurate information, there would be a lot of risk involved in receiving that in a non-supported environment."
But other Utah health officials say greater accessibility to testing is a positive development.
"The more people that get tested and know they have HIV, the better off we are going to be," said physician Kristin Ries, director of University of Utah Hospital's Infectious Diseases/HIV Clinic.
Traditional testing requires blood to be drawn and sent to a lab for analysis. Results are returned in about two weeks.
"Less than half of the people tested ever come back for their results," Ries said.
The FDA approved the first partial home HIV testing kit, made by Home Access Health Corp., in 1996. About a dozen HIV home testing kits are currently available to the public, but the Home Access kit remains the only one with FDA approval.
For about $60, it provides the materials for a blood sample to be collected and mailed to a laboratory. The sender calls for results within a day or two, and has the option to speak with a counselor. The test includes information about how to find counseling.
In OraSure's kits, a swab is used to gather a sample of saliva and placed in a vial. Within about 20 minutes, it indicates whether HIV antibodies are present. OraSure says the tests have a 99 percent accuracy rate.
The quick test is only a preliminary exam, Ries notes.
"If you do it at home, go get it confirmed," Ries said, "because it may not be positive."
The public's response to the rapid test has been outstanding, said Dave Ferguson of the Utah AIDS Foundation. Before the foundation started using the OraSure product, they tested about 400 people a year.
Last year, the foundation administered tests to more than 2,000.
In a clinical setting, health officials and doctors can deliver the results within minutes and can offer one-on-one advice to a patient.
"That counseling is the best HIV prevention tool we have," Ferguson said.
The home test has other drawbacks. Tracking HIV infection rates will be more difficult, Fronberg said. The kits must be stored or shipped within a certain temperature range or they can give false-positive results. Expiration dates will need to be observed. And the more the tests are used, the greater impact their failure rate - which is less than 1 percent - will have, Ries said.
OraSure sells the tests to doctors for between $12 and $17. It has not announced how much it will cost the public, according to the FDA.
Ries and Ferguson agree the problems associated with a home test can be overcome through education.
"It's a different world than it was 10 years ago," Ries said. "There's no reason to be ashamed. There's no reason to hide."
Ferguson said he is surprised how often people respond to a positive test result by feeling that contracting HIV is a death sentence.
Utah offers several programs that can assist HIV-positive individuals with counseling and health care.
"It's important that folks understand that as long as they access consistent and quality medical care, HIV can be managed," he said.
mwestley@sltrib.com
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The Associated Press contributed to this report.
For information about HIV/AIDS testing and issues:
* Utah State Health Department
288 N. 1460 West, Salt Lake City
801-538-6096
http://health.utah.gov/els/hivaids/index.html
* The People With AIDS Coalition of Utah
1390 S. 1100 East, Suite 107
801-484-2205
http://www.pwacu.org
* Utah AIDS Foundation
1408 S. 1100 East, Salt Lake City,
801-487-2323 or hotline at 800-865-5004
http://www.utahaids.org

