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January 2004
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HIV tests: Fast results vs. privacy protection

Package for the Home Access HIV test.
"HIV testing can now be accomplished in three minutes, in the privacy of your home," claims the Web site for Discreet, a do-it-yourself blood-screening test for the HIV virus. The Canadian manufacturer promises "immediate, accurate, and 100 percent private results," for $29.95 plus shipping and handling.

Another maker, Health Diagnostics, of Monaco, offers a one-minute HIV self-test over the Internet for $39.95 plus shipping. Charles Dupont, Health Diagnostics’ general manager, said in an e-mail interview that a significant percentage of the company’s sales are to the U.S.

However, neither of those instant HIV home tests is approved by the Food and Drug Administration. When the FDA tested other unsanctioned home tests in the past, some tests failed to detect known HIV-positive samples. "The bottom line is that it’s illegal for a manufacturer to market an unapproved HIV test in the U.S.," says Elliot Cowan, Ph.D., associate director at the FDA’s Division of Emerging and Transfusion Transmitted Diseases. "When it comes to something as important as being tested for HIV, you want to be as certain as possible that the test you’re using will give you a correct result."

Recently the FDA approved two speedier, though not necessarily anonymous, doctor’s-office blood tests, MedMira Reveal and OraQuick Rapid HIV-1 Antibody Test. According to FDA-approved claims, both are better than 99 percent accurate and give results in minutes. That’s much faster than standard HIV tests, which can take several days to two weeks for results. Each year some 26 percent of those who test positive for HIV at public clinics--about 8,000 people--never return to learn their results.

Anonymity may not be assured when HIV tests are given in a doctor’s office or clinic. Names of those who test positive are recorded in 11 states (Alabama, Idaho, Iowa, Mississippi, Nevada, the Carolinas, the Dakotas, Tennessee, and Wyoming). Other states offer anonymous testing only at some sites.

For anonymous results, use the one FDA-approved home test, the Home Access HIV test, marketed by Home Access Health, of Hoffman Estates, Ill. It is as accurate as doctor’s office tests; positive results are automatically retested. Users mail in a drop of blood on a special card, wait three to seven business days, then phone in anonymously for results, counseling, and medical and social-service referrals. Express (three-day) kits are available at retail pharmacies for $60. Kits can also be ordered online at www.homeaccess.com or by calling 800-448-8378.