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[procaare] Drug Agency Approves a Quick Test for HIV

  • From: ProCAARE <procaare@usa.healthnet.org>
  • Date: Thu, 21 Nov 2002 13:55:57 -0500 (EST)

Drug Agency Approves a Quick Test for HIV

The Food and Drug Administration approved a test today that can detect whether someone is
infected with HIV, the virus that causes AIDS, in as little as 20 minutes. Experts said
that advance might prompt thousands more Americans to get tested, which in turn might slow
the spread of the disease.

The "while you wait" test, by OraSure Technologies Inc. of Bethlehem, Pa., will not be the
first rapid H.I.V. test on the market. But, with a 99.6 percent accuracy rate, it is the
first one that is highly reliable.

Standard tests for HIV now take two days to two weeks to provide results, a time lag that
experts say discourages thousands of people each year from returning to their testing
center to find out whether they are infected.

"It's simple, it's accurate and it's very fast," Tommy G. Thompson, the secretary of
health and human services, said of the new test.

Mr. Thompson called the agency's action "a very important step in America's war against

Public health experts say the test is important for several reasons. It may help reduce
mother-to-infant transmission of H.I.V. by enabling doctors to test pregnant women while
they are in labor. It will also offer health care workers exposed to H.I.V.-tainted blood
a quick way to determine if they need antiviral drugs that could prevent them from getting

In addition, with the Bush administration considering whether to vaccinate all Americans
against smallpox, the new test will offer health professionals a fast, easy way to
determine if someone is infected with H.I.V., and thus ineligible for the vaccine.

An estimated 900,000 Americans are infected with the human immunodeficiency virus, but as
many as a quarter of them do not know it, Mr. Thompson said. Each year, he said, as many
as 8,000 people are tested and never return to find out the results.

Federal health officials said the OraSure test might sharply cut those numbers. Cornelius
Baker, executive director of the Whitman-Walker Clinic, a large AIDS healthcare agency in
Washington, agreed.

"Right now, people come in for a test and they have to come back two days later to find
out the results," Mr. Baker said. "This means we will be able to see more people, because
we will be able to give people counseling and a test in one session as opposed to two."

To use the test, a health care worker pricks a patient's finger and draws a single drop of
blood, which is dropped into a small vial that contains a liquid solution. The testing
device, which resembles a dipstick, is then inserted into the vial.

The test detects whether antibodies to HIV are present in the patient's blood. It takes 20
minutes to an hour to get results, company officials said.

There is, however, one hitch: people infected with HIV do not develop antibodies to the
virus until three months after exposure. So the Food and Drug Administration recommends
that people who test negative repeat the test if they believe they have been exposed to
the virus. The agency also recommends that, in the case of a positive test, a more
traditional test be conducted to confirm the results.

The agency has approved the test, called the OraQuick, for use in hospitals, clinics and
doctors' offices that meet certain federal laboratory standards.

Because it is so easy to use, Mr. Thompson said, the government may eventually consider
making it available more broadly, perhaps even to social workers in HIV. counselling
centers. Before that happens, however, OraSure must conduct another clinical trial to
prove that untrained people can administer the test as reliably as health professionals.

Mike Gausling, the company's chief executive, said OraSure had already submitted a testing
proposal to the food and drug agency.

Mr. Gausling said he did not know what the test would cost. But he said it would probably
be cheaper than the company's other test for HIV, a saliva test that costs about $20. He
said it would take about 45 days to get the first 50,000 OraQuick tests to the market.

Sheryl Gay Stolberg:

Source: New York Times. Nov 8. 2002
Cross posted :[JVNET] jvnet@netnam.vn

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