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FALSE POSITIVITY PHENOMENON POSES NO HEALTH RISK

 FALSE POSITIVITY PHENOMENON POSES NO HEALTH RISK
 WASHINGTON, Dec. 18 /PRNewswire/ -- Blood establishments have


reported to the Food and Drug Administration and the Centers for Disease Control that some prospective donors who recently received influenza vaccine have tested falsely positive on three commonly used screening tests -- those for detecting antibodies to Human Immunodeficiency Virus type-1 (HIV-1), Hepatitis C and Human-T- Lymphotropic Virus-type 1.
 Additional testing showed the false reactions were not related to infection with any of these viruses. Because additional testing clearly showed that the donors were not infected with these viruses, none of them were told of the false results.
 Assistant Secretary for Health James Mason, M.D., who heads the Public Health Service, said, "Although these false positive reactions may pose some inconvenience to blood donors and blood establishments, they represent no risk to the safety of the blood supply.
 "I also want to assure the public that the flu vaccine is safe. Flu vaccination does not carry risk of these diseases, and it is important that people for whom flu vaccine is recommended continue to receive it because this is shaping up to be a bad winter for the flu."
 In the past few weeks, approximately 90 blood donors from more than 20 blood establishments across the country have been reported to have tested repeatedly reactive in antibody tests used to screen for these three infections. Additional testing showed that these reactions were false -- that these individuals did not actually have antibodies to these viruses.
 Further analysis has just begun, but early indications are that at least 60 percent of these donors had recently been vaccinated against the flu. Two percent of the donors with false positive reactions stated that they had not received flu vaccines, and vaccination history of the remaining donors is not currently known.
 FDA is working with screening kit and flu vaccine manufacturers to determine the reason for the false positive reactions and what can be done to overcome them. These false reactions may be due to a kit component used in all three antibody test kits manufactured by Abbott Laboratories of Abbott Park, Ill.
 Although the Abbott antibody test kits have been involved in all of the reported cases, other manufacturers' antibody kits might be subject to the same phenomenon. Abbott Laboratories has fully cooperated with FDA's Center for Biologics Evaluation and Research in examining this situation and keeping users informed.
 No one who receives a flu vaccine is at risk of contracting any known infection from the vaccine, and there is no risk of contracting HIV, Hepatitis C or HTLV-1 from flu vaccination. FDA will provide appropriate guidance to blood establishments, test kit manufacturers and flu vaccine manufacturers as clarifying information becomes available.
 FDA and the CDC are among the eight Public Health Service agencies within HHS.
 -0- 12/18/91
 /CONTACT: Brad Stone of the Food and Drug Administration, 301-443-3285 or, after hours, 703-892-0468/ CO: Food and Drug Administration ST: District of Columbia IN: HEA SU:


TW -- DC019 -- 3583 12/18/91 16:49 EST
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Copyright 1991 Gale, Cengage Learning. All rights reserved.

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Date:Dec 18, 1991
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