Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 10 Aug 95
The first of the new Food and Drug Administration recommendations concern a new test for HIV, the AIDS virus, that is nearing the market.
Currently, blood donors are tested for an immune reaction to HIV, but it can take up to 25 days after HIV infection for that reaction to occur. Colter Corp. of Miami has created a test that will detect the virus itself about six days earlier, and the FDA said it is just about to approve the test as soon as some details are worked out.
Meanwhile, the FDA wrote the American Red Cross and other blood centers this week that they should be ready to begin using the new tests within three months of their sale.
The agency unveiled its decision late Thursday. Blood centers could not be reached for comment, but they had supported the change.
Although getting HIV from a blood transfusion today is extremely rare -- about 40 cases from 18 million units of blood -- closing the testing "window period" will prevent five to 10 such infections each year, the FDA said.
An FDA panel of scientific advisers last month recommended the agency not push the new tests, when some voiced concern that they could cost the blood industry up to $200 million a year to implement. But the FDA disagreed.
In another decision late Thursday, the FDA told blood banks to recall all blood products donated by people later discovered to have Creutzfeldt-Jakob disease.
Scientists have no proof that the rare, fatal brain disease is transmitted through blood. But it can be transmitted through tissue and a handful of blood donors have been diagnosed with the disease, so the FDA decided to take extra precautions.
The decision could involve thousands of patients and millions of units of blood products because many plasma products are made of blood pooled from tens of thousands of donors.
Creutzfeldt-Jakob disease afflicts just one in a million people. No one knows what causes it; there is no test to detect it and no treat, and patients usually die about seven months after symptoms appear.
Seven patients with the disease who donated blood in this country have been discovered since 1983, three since last fall. In each case, blood banks voluntarily recalled or quarantined the blood products, at a cost of more than $50 million.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
950810
AP950812
Copyright © 1995 - 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 1995. 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, 1995. 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. .