- The Washington Times - Saturday, March 27, 2004

The Food and Drug Administration has approved a new oral test to detect the AIDS virus that is highly accurate and gives the results in 20 minutes without using a needle.

The new test is the second rapid HIV-screening tool to come on the market since November 2002. The standard test requires pricking a person’s finger to test a drop of blood, which can be painful.

Using the new oral test, health care workers simply wipe a treated test strip along a patient’s upper and lower gums, place the swab in a special testing liquid and wait 20 minutes for the results. If one line appears on the strip after the short wait, it means, with 99.8 percent accuracy, the person is not infected with the human immunodeficiency virus that causes AIDS.

If two lines appear, the likelihood of HIV infection is 99.3 percent, federal health officials said at a news conference in Washington yesterday.

“This oral test marks a giant step forward in the war against AIDS in America and around the world,” Tommy G. Thompson, secretary of the Department of Health and Human Services, told reporters at the briefing.

He said needle-free testing “will improve care” for “people who might be afraid of a blood test and improve the public health as well.”

The test can quickly and reliably detect antibodies to HIV-1 and can be stored at room temperature and requires no specialized equipment, according to the FDA.

The federal Centers for Disease Control and Prevention estimates there are between 850,000 and 950,000 Americans infected with HIV and that a quarter of them don’t know it. “That means 225,000 Americans don’t know they have the life-threatening” viral condition, said Mr. Thompson.

Moreover, the secretary said, “Each year 30 percent of people” who get tested for HIV “don’t return for their test results.” Consequently, they do not know whether they are infected and might continue risky behavior that puts sex partners and others at risk for HIV infection.

Dr. Jesse Goodman, director of the FDA’s Center for Biologics, Evaluation and Research, who also spoke at the news conference, said the new test is safer for health workers who have been known to become infected by needles tainted with HIV.

Both the new test and the 2002 rapid blood test were produced by OraSure Technologies Inc. of Bethlehem, Pa. The official name of the new test is the OraQuick Rapid HIV-1/2 Antibody Test, according to OraSure spokesman Bill Bruckner.

When OraSure’s speedy HIV blood test first reached the marketplace, it was viewed as a way to increase the number of people who knew they were infected with HIV. There have not been studies to determine whether the rapid blood test has had that effect.

But Mr. Thompson said yesterday he is certain the new noninvasive OraQuick mouth test “will greatly reduce the number” of Americans who are in the dark about their HIV status.

“This will be a real godsend,” he said.

Initially, the new OraQuick test will be available in about 40,000 medical laboratories nationwide. But Mr. Thompson urged OraSure officials yesterday to seek a waiver to the 1988 federal legislation that set standards for lab practices, so this “really simple” and “accurate” test can be made available in 180,000 different settings, including physicians’ offices, public health clinics and mobile vans.

“This test is a historical milestone, because it can be used anywhere, anytime by virtually anyone,” Mike Gausling, president and chief executive officer of OraSure said at the news conference.

He said there is a possibility that eventually it could be used as a home test.

Mr. Gausling and federal officials both said the new test has significant potential for use in AIDS-plagued Africa because of its low cost, ease of use and fast results. Mr. Bruckner of OraSure said the price of the test will range between $12 and $15, which is comparable to the amount charged for the rapid blood test.

Mr. Gausling said his company’s rapid and accurate gum-swabbing HIV test already has been used to confirm results of other HIV tests in Africa. In this country, however, anyone who tests positive for the AIDS virus via the new method will be given an additional test to confirm HIV infection.

Before the introduction of OraSure’s rapid blood test for HIV in 2002, testing to determine presence of HIV routinely took up to two weeks.

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