FDA Panel Backs AIDS Test as Diagnostic Tool

A federal advisory panel has proposed that the AIDS antibody test no longer be deemed “inappropriate . . . as a screen for AIDS or as a screen for members of groups at increased risk for AIDS.”

Members of the Food and Drug Administration’s advisory committee on blood and blood products, in reviewing guidelines that accompany test kits, said that more information is available now about the reliability of the test than a year ago, when it was introduced solely in an effort to keep the AIDS virus out of the nation’s blood supply, and experts increasingly recognize that it might be used to diagnose the disease.

“We felt very strongly then (a year ago) that the test was for blood, not people,” said Dr. Louise Keating, chairman of the committee and director of the Northern Ohio Red Cross Blood Services. “But I think a lot of us have changed our minds.”

The test has been consistent in “picking up positives” in the high-risk AIDS population, she said, with only rare instances of positives among those who do not belong to any high-risk groups.

Dr. Harry Meyer, director of the FDA’s Center for Drugs and Biologics, said: “It was clear the test would have uses other than for the blood supply as we identified more good public health reasons to use it.”

He said studies this year have shown “a high frequency” of the virus among those who test positive, meaning that the AIDS virus is present in their blood.

This further validation of the test for diagnostic purposes issued Friday as part of an ongoing review is expected to fuel the growing debate over use of the test by insurance companies, which are seeking its results to determine health and medical coverage, and by others, such as employers.

CDC Guidelines

The federal Centers for Disease Control, indicating that it already considers the procedure of diagnostic value, includes a positive test in combination with specific symptoms, as part of its determination of who has AIDS.

And in developing recommendations for the public health community, CDC has incorporated voluntary use of the test into guidelines affecting certain high-risk groups, such as women intravenous drug users who wish to become pregnant. It has also suggested--although it has not formally recommended--that members of high-risk groups, including male homosexuals and bisexuals, intravenous drug users and their steady sexual partners, be encouraged to take the test.

The Pentagon has adopted the test throughout the military and the Health and Human Services Department has proposed that it be used to screen all permanent immigrants.

The procedure does not diagnose AIDS. A positive test means only that a person has been exposed to HTLV-III, the virus that causes AIDS, and has developed antibodies to it.

However, public health authorities now believe that someone who repeatedly tests positive is infectious.

AIDS Characteristics

AIDS, or Acquired Immune Deficiency Syndrome, destroys the immune system and renders the body powerless against otherwise rare infections. It is spread through intimate sexual contact and the sharing of unsterilized hypodermic needles. Before the test was developed, the disease was also transmitted through blood transfusions and blood products.

The revised guidelines also for the first time contain language urging strict confidentiality of test results.