FAST SALIVA TEST FOR HIV GAINS FEDERAL APPROVAL
28 Mar 2004
Source: New York Times, March 27, 2004.
Fast Saliva Test for H.I.V. Gains Federal Approval
By DONALD G. McNEIL Jr.
The Food and Drug Administration approved yesterday the first H.I.V. test that uses saliva rather than blood and delivers results in 20 minutes.
Public health officials hope the new test will encourage wider and more frequent testing. About 25 percent of all Americans carrying H.I.V., the virus that causes AIDS, do not know that they are infected, according to estimates by the Centers for Disease Control and Prevention. Around the world, according to the World Health Organization, that figure may be as high as 95 percent.
Although the test is as easy to use as a home-pregnancy kit and could eventually revolutionize H.I.V. testing, the company, OraSure Technologies of Bethlehem, Pa., is not yet seeking the right to sell it over the counter.
The test, the OraQuick H.I.V.-1/2 Test, is more than 99 percent accurate, said Michael Gausling, OraSure's president, and offers "more dignity, greater ease and no risk of transmission."
Tommy G. Thompson, the secretary of health and human services, announced the approval in a news conference yesterday in Washington along with the officials from the company, the drug agency and the C.D.C. Mr. Thompson called the test "another important option for people who might be afraid of a blood test."
Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases and a prominent AIDS researcher called the test "a very good thing."
"It's extraordinary how many people don't come back for follow-up when they have to wait two weeks," Dr. Fauci said.
Typical H.I.V. tests require a vial of blood and are sent to a laboratory that returns results in 2 to 14 days. Two years ago, the drug agency approved an OraSure test that used only a drop of blood from a finger-prick and took 20 minutes, and the company has since sold more than 500,000 of them, Mr. Gausling said.
The new test uses the same technology and works as quickly, but with saliva, which is hundreds of times less infectious, and therefore less dangerous to the tester.
It uses a plastic stick with a pad that is rubbed against the gums and put in a vial of reagent solution. Within 20 minutes, if the result is positive, two reddish-purple lines appear on a window on the handle.
The company says the new test can detect H.I.V. antibodies as soon after infection as earlier tests can — roughly six weeks, though the time for each person varies.
For now, it can be used only in certified laboratories, but Dr. Lester M. Crawford, the acting commissioner of food and drugs, "strongly urged" the company yesterday to apply for a waiver that would let the test be used in simpler settings, like neighborhood clinics.
With such a waiver, Mr. Gausling said, "anyone with a seventh-grade education can administer the test if they can read instructions."
Dr. Fauci said he thought it was "almost certain" a waiver would be granted.
Mr. Gausling said he expected to charge $8 to $20 a test, depending on how many are ordered. This would be cheaper than current laboratory testing. Shares of OraSure rose 19 percent yesterday, closing at $9.70.
Mark Harrington, executive director of the Treatment Action Group, which lobbies for better AIDS treatment, welcomed the new test but warned that it could be abused.
"What if they started using it on every immigrant at every airport?" Mr. Harrington asked. "I'd see that as a violation of human rights."
He also said he worried that the test would make it easier for the police or prison guards to give tests without consent, or for health authorities to test outside nightclubs or gay bars when patrons were too drunk to give legitimate consent or to be helped by counseling if the tests proved positive.
The test is for preliminary screening and must be confirmed with a more sophisticated test before treatment is begun, the company said. It is not approved for screening blood donors.
Saliva tests, including OraSure's, have been used for years in some underdeveloped countries where patients may be many miles from a clinic, said Dr. Basil Vareldzis, an AIDS specialist in Geneva.
They are also useful for testing drug abusers, he said. Needle-sharing is the most common mode of transmission of H.I.V. in Russia, Eastern Europe and some American cities.
"It's a big deal to get blood from an injection-drug user," Dr. Vareldzis said. "Some have veins that are all sclerosed. And former users in recovery can be really squeamish about being exposed to needles again. It's like giving a teaspoon of cough syrup with alcohol to a recovering alcoholic."
Several experts said saliva tests would be useful for anonymous surveillance. In South Africa in the late 1990's, a well-known study of AIDS among truckers used prostitutes at highway truck stops to get their clients to spit in jars, which were then put on ice and sent to a laboratory.
Although OraSure makes H.I.V. tests for the life-insurance industry, Mr. Gausling said he doubted that insurance salesmen would want to give rapid tests because of the trauma that could ensue if a potential client proved positive.