AEGiS-AP: 5-minute AIDS Test Approved For Sale; Called 99% Accurate Associated PressImportant note: Information in this article was accurate in 1988. The state of the art may have changed since the publication date.
Click here to return to Associated Press main menu




DonateNow



5-minute AIDS Test Approved For Sale; Called 99% Accurate

The Associated Press; Thursday, December 15, 1988.


BOSTON - The first five-minute test for AIDS has been approved by the U.S. government, and authorities say it is 99.6 percent accurate and offers the fastest results.

The test was cleared Tuesday by the U.S. Food and Drug Administration. Its maker, Worcester-based Cambridge Bioscience, said it should be on the market in a few weeks.

"This technical advance should help make testing available to all who want to be tested," FDA Commissioner Frank Young said in Washington. "It will also be particularly useful in remote areas of the world that lack the facilities for earlier approved tests."

The results of those earlier tests -- now the mainstay of AIDS screening -- frequently are not available for weeks.

Gary Buck, chairman of Cambridge Bioscience, said the new procedure, the Recombigen HIV-1 Latex Agglutination Test, should be useful anywhere that quick results are important.

"The big boon is that it's fast, and it will be useful in Third World countries and places where lab facilities might be less than ideal in order to screen large populations in a rapid, simple way," said Dr. Paul Skolnik, a virologist at New England Medical Center.

The test is 99.6 percent accurate, Buck said. But the company recommends that -- as with the current screening test, called the enzyme-linked immunosorbent assay, or ELISA -- blood samples that are positive for the AIDS virus be confirmed by a time-consuming backup test called the Western blot.

The speed of the Recombigen means that those who are free of the virus are likely to be given the good news immediately, Buck said. But those who are probably infected will be told that further testing is necessary.

Like other AIDS tests, this one checks for AIDS infection by spotting antibodies to the human immunodeficiency virus, or HIV, which causes AIDS.

"All of the present (ELISA) tests require, under the best of circumstances, three to five hours," Buck said. "This test requires three to five minutes."

Unlike the ELISA, which requires labs and technicians, the new test can be given under crude conditions where even refrigeration is lacking. Experts believe that this should make the test useful in places like Africa, where acquired immune deficiency syndrome is widespread and where blood is frequently not screened before transfusions.

Teena Lerner, an analyst at Shearson Lehman Hutton in New York, said the test also may be given in many settings in the United States, such as venereal disease clinics.

"In a lot of the voluntary testing centers, there is a huge proportion of people who don't come back to find the answer," she said. "The ones who are most likely to be positive are the ones who are most likely to chicken out."

CAPTION: PHOTO Gary Buck shows AIDS test (--NATL)


881215
AP881204


Copyright © 1988 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.

Always watch for outdated information. This article first appeared in 1988. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1988. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .