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AIDS: new steps to protect the blood supply.

AIDS: New steps to protect the blood supply

A national study of the prevalence of human immunodeficiency virus antigen in blood donors was approaching a launch at MLO press time.

HIV antigen is the marker that may appear before antibody in the blood of a recently infected individual. There is no test currently licensed by the Food and Drug Administration to detect the antigen, but Paul J. Schmidt, M.D., president of the American Association of Blood Banks, noted that several diagnostics manufacturers have researched tests to the license application stage. He said at least one of the companies indicated it would make its experimental procedure available for the blood donor study.

The aim would be to determine the usefulness of antigen tests for detecting donors in the early stages of HIV infection. Plans called for the AABB, the American Red Cross, and the Council of Community Blood Centers to conduct the study in cooperation with the FDA and the Centers for Disease Control. Each blood service organization would test a representative number of donors who have already undergone the donor screening procedures and antibody testing in place today.

Specifically, the study would focus on 1) how many additional HIV-infected donors the antigen tests detect after other screening has taken place, and 2) whether that number warrants antigen testing of all would-be donors and donor blood in the United States. Dr. Schmidt anticipated that the research and decisions based on it would be completed this year.

Plans for the study were disclosed after a report in the Feb. 25 issue of the New England Journal of Medicine raised concern about the safety of transfusions administered to more than four million persons in the U.S. annually. In the journal report, CDC researchers and blood center scientists traced 13 HIV-infected blood units to seven individuals who served as donors even though they had recently been exposed to the virus.

"The announcement about donors who slipped through the screening net was not a surprise," Dr. Schmidt said. "Because the available tests are nearly 99 per cent, and not 100 per cent, sensitive and specific, and because we know that persons recently exposed may not develop for some weeks the antibody that our tests can detect, we expected that there would be some infection developing in transfusion recipients. We are working on solutions to the problem of detecting persons even earlier in this infectious state, and on how to discourage them from donating blood."

Dr. Schmidt added: "To keep the risk in perspective, it is important to realize that this article reports on 13 transfusion recipients who became infected. Since July 1985, when testing for HIV anti-body was fully implemented in our blood collection system, there have been approximately 10 million recipients of blood. The risk of harm from not getting a needed transfusion is infinitely greater than the risk of harm from getting the transfusion."

Since early 1983, persons at risk for HIV infection have been asked not to donate blood. These persons are identified by questions asked prior to donation, a practice that has continued since the HIV antibody test was licensed for use in 1985.

The blood service organizations are working with the FDA and the CDC to determine whether donor screening criteria need to be made even stricter and how communication to donors can be improved. In the New England Journal study, all but one of the donors fit into existing high-risk behavior patterns but did not admit to it during donor screening.

In October 1986, after the donations reported in the New England Journal article, the blood service organizations introduced still another procedure, "confidential unit exclusion." This is intended for someone who may be at high risk for HIV infection but feels peer pressure to donate blood anyway. The individual can confidentially designate his or her donation "for research/laboratory purposes only." Another safety mechanism provides a phone number that a donor may call to request that his or her blood unit be destroyed.

The system isn't perfect, but AABB and the other blood service organizations have averted disaster and are now concentrating on making transfusion-transmitted disease rarer and rarer.
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Author:FitzGibbon, Robert J.
Publication:Medical Laboratory Observer
Article Type:editorial
Date:Apr 1, 1988
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