RAPID HIV TEST APPROVED BY FDA




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2001

Last Updated

28 Dec 2002

Source: Los Angeles Times, November 8, 2002.

Rapid HIV Test Approved by FDA

The procedure is a 'sea change,' activist says. In the past, waits of up to two weeks caused anxiety and led many to not find out results.

by Charles Ornstein, Times Staff Writer

Federal officials approved a finger-prick HIV blood test Thursday that can provide results within 20 minutes, reducing delays that cause anxiety and lead many people not to pick up their test results.

"This is a real sea change," said Lee Klosinski, director of programs at AIDS Project Los Angeles. "These results are so important ... that we really want to find ways to get them out to people as quickly as possible."

The approval was announced by Tommy G. Thompson, U.S. secretary of Health and Human Services, who characterized it as "a very important step in America's war against HIV/AIDS."

The new test, called OraQuick, is 99.6% accurate and requires less than a drop of blood.

The standard test for HIV, known as ELISA, takes a minimum of five hours to process and sometimes as long as overnight. But because the test often is sent to labs -- where it is run in batches -- results often are not available for up to two weeks.

The government estimates that each year, more than 8,000 HIV-positive people do not return to public clinics to receive their test results.

As a result, they may be infecting others and may not be receiving needed treatment.

A much higher number of virus-free people don't return for their results.

The rapid HIV test will be available only in 40,000 technically sophisticated labs that receive special certification from the federal government.

That will prevent many groups from providing instantaneous results to sex-club visitors, homeless people on the street and emergency-room patients, who are among the most likely not to return for their results, experts say.

Thompson encouraged the test's maker, OraSure Technologies Inc., to submit evidence that OraQuick is easy to use and has little potential for user error.

If the Bethlehem, Pa.-based company can prove that, the government could allow for more expanded testing, he said.

Advocates for the rapid test say the wait to find out results creates unnecessary anxiety and fears.

One 23-year-old man, who was recently tested at an AIDS Healthcare Foundation clinic, said he had difficulty sleeping for a week afterward. He was virus-free.

"That was one of the most stressful weeks of my life," said the man, who requested anonymity. "I try to protect myself and I try to practice safe sex, but things do go through condoms, and I was worried about that.

"Nothing that I did was fun, because that was in the back of my mind."

HIV activists and members of Congress have criticized the federal government for delaying the introduction of rapid HIV tests.
But officials at the Food and Drug Administration dismissed those suggestions Thursday, saying OraSure submitted its final application about a year ago.

The agency said it worked quickly to review its data and inspect its manufacturing facilities.

"I feel that we had an excellent relationship with the company," said Dr. Elliot Cowan, a senior regulatory scientist at the FDA. "They listened to us, and conversely, we listened to them."

Michael Weinstein, president of the AIDS Healthcare Foundation, said he hopes that rapid HIV tests will eventually be "no muss, no fuss" and that it will eventually be like "putting your arm in a blood-pressure sling in the drugstore."

When the OraQuick test detects the presence of HIV antibodies, it displays two red bars on a small strip enclosed in plastic. One red bar indicates a negative result.

Officials at the California Office of AIDS said state law requires that two HIV tests be performed before people can be told that they have the virus.

As a result, health authorities are working on language that would enable clinics to tell patients that they probably are infected but that they must get a different test, which could take days or weeks to process.

The Los Angeles Gay and Lesbian Center said its in-house lab is ready to use the new test, but rules prevent the center from performing screenings in its new mobile testing van, as the group would like. The center performed 8,510 HIV tests in 2001.

"This is a really important first step," said Jeff Bailey, the center's director of health education and prevention.

Consumers wanting to use the HIV test at home shouldn't hold their breath. Because "counseling is an integral part of the equation, over-the-counter is not a solution in today's world," OraSure Chief Executive Mike Gausling said in a telephone conference call.

However, Gausling didn't close the door on the option. "Pregnancy tests used to have to have counseling too," he said, but now they don't.