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FDA to Consider Rapid, At-Home HIV Test
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By Randy Dotinga
HealthDay Reporter
WEDNESDAY, Oct. 26 (HealthDay News) -- If women can take a pregnancy test at home and get an answer within minutes, shouldn't individuals be able to take a rapid HIV test in the privacy of their home, too?
That's the question facing U.S. health officials who will soon debate how Americans can get the news about whether they're infected with the AIDS virus.
On Nov. 3, a Food and Drug Administration advisory panel will begin considering whether to let OraSure Technologies Inc. sell its OraQuick test over the counter. The tests, which have become extremely popular in just a year, are now available at doctors' offices for $12 to $17 each.
For years, health officials assumed that an AIDS diagnosis was too stressful for patients to handle outside the confines of a doctor's office or health clinic. In many cases, doctors made extensive counseling available because of worries that people would commit suicide after receiving an HIV diagnosis.
But things have changed over the years. Thanks to powerful drugs developed in the early 1990s, AIDS has become more of a chronic -- though still deadly -- disease.
Concerns remained, however, about how people would handle news of an HIV diagnosis, said Thomas Coates, an AIDS specialist and professor of medicine at the University of California, Los Angeles.
"We've taken this very patronizing attitude toward people that they can't stand the information, it's too earth-shattering, they might freak out," Coates said. "It's time to let people have access to the information."
As AIDS treatments became stronger and more effective, technology improved, allowing quicker and easier HIV tests. First, a quick HIV blood test appeared, allowing patients to get a result in 20 minutes instead of waiting for laboratory results. The test also allowed patients to give blood from a tiny prick, like those used in glucose tests for diabetics, instead of a traditional blood sample taken through a needle in the arm.
About a year ago, OraSure introduced an oral HIV test after receiving approval from the FDA. The OraQuick test device looks a bit like an electronic oral thermometer. Users insert a porous pad between their cheek and gums, then stick it into a test chamber, said Ronald Spair, OraSure's executive vice president and chief financial officer.
A reddish-purple line will appear if the test is working correctly, and a second line will show up if HIV antibodies are detected in the oral fluid. "Two lines means you've screened positive, one means you've screened negative," Spair said.
Antibodies, the soldiers of the immune system, appear in response to germ invasions. "Around your gum line, the fluid that circulates is rich in antibodies and proteins that cross over from your blood," Spair said.
There's a potential hitch with such testing, however. It takes a while for the immune system to detect HIV and create antibodies. For that reason, the oral HIV tests won't reveal that someone is HIV-positive immediately after infection occurs.
It may take several weeks after infection for the test to pick up antibodies, Spair said. More sophisticated tests available in doctors' offices are designed to pick up HIV infection earlier, potentially preventing people from spreading the disease without knowing they're sick.
Both the speed and the ease of the oral HIV test would be new. Currently, people can take HIV tests at home, but they must send a blood sample to a laboratory and wait three to seven days for results, Spair said.
It's not immediately clear how long the FDA might take to make a decision about the over-the-counter sale of the rapid oral HIV test. The price isn't known either. But OraQuick does plan to make counseling available to test users, Spair said.
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