NEWS

03/14/1996



<TITLE> FDA APPROVES FIRST TEST FOR HIV ANTIGEN SCREENING OF

BLOOD DONORS </TITLE>

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P96-6                                Food and Drug Administration

FOR IMMEDIATE RELEASE                Lenore Gelb (301) 443-3285

March 14, 1996                                              



FDA APPROVES FIRST TEST FOR HIV ANTIGEN SCREENING OF BLOOD DONORS



     The Food and Drug Administration today announced the

approval of the first antigen test kit to screen blood donors for

HIV-1, the virus that is responsible for the vast majority of

AIDS cases in the United States.    

     Currently, blood donors are screened with tests that detect

HIV antibodies, which typically appear within three months after

infection and indicate the body is responding to the infection. 

In contrast, antigens, which are the virus' own proteins, can be

detected about one week earlier than antibodies.

     The new test kit was also approved to be used as needed in

the diagnosis of HIV-1 infection and to monitor the progress of

the disease itself.  However, while the FDA recommends that the

antigen test be used to screen blood donations, the Public Health

Service does not recommend that it replace the HIV antibody test

for routine patient testing and counseling in a medical setting. 

Antibody testing at the recommended intervals is still the most

efficient way for health care providers to routinely diagnose HIV

in individual patients.       

     "This new HIV screening test should increase public

confidence in the safety of the U.S. blood supply,"               

                              -More-                                Page 2, P96-6- Antigen Screening

Assistant Secretary for Health Philip R. Lee, M.D., said.  "For

any patient who needs blood, the risk of getting AIDS from a

transfusion will be even more remote than before." 

     By reducing the so-called "window" period, when donors may

be HIV-infected but still have negative antibody tests, it has

been estimated that HIV-1 antigen screening could prevent

approximately 5-10 cases per year or up to 25 percent of current

cases of AIDS transmitted by transfusion.  

     "We will never totally eliminate the risk of HIV

transmission through transfusion, but we have taken important

steps to further reduce what is already a very small risk," said

Commissioner of Food and Drugs David A. Kessler, M.D.  

     The new screening test kit is manufactured by the Coulter

Corporation, Miami, Fla.  

     Based on an Aug. 8, 1995 FDA recommendation to all

registered blood and plasma establishments, the Coulter HIV-1 p24

Antigen Assay, or other similar tests that may be approved later,

will start being used within 90 days of this first approval. 

Testing for antibodies to HIV-1 and HIV-2, a type of the virus

rarely found in the U.S., will continue to be performed in

addition to other recommended safeguards to reduce the chance of

HIV-contaminated blood entering the blood supply.  Other

safeguards include the questioning of potential donors about risk

behaviors. 

     The agency's decision to approve the test kit for donor 

                               -More-                                 Page 3, P96-6, Antigen Screening

screening was based on a review of safety and effectiveness data.

The Coulter test detected HIV-1 antigen before antibodies were

detected in 80.6 percent of the cases studied.  Also, the test

was able to correctly identify HIV-1 negative specimens 99.95

percent of the time based on evaluations of 301,699 normal blood

donations.  Although an HIV-1 antigen test kit (HIVAG-1),

manufactured by Abbott Laboratories was approved in 1989 for

diagnosis and monitoring purposes, it was not approved or labeled

for donor screening in blood establishments.  

     Studies at that time indicated no evidence of HIV antigen-

positive, antibody negative blood donations after screening over

500,000 samples.  However, since 1989, four cases of HIV-1

infection have been discovered to come from blood donations that

were later found to be HIV-1 antigen positive, but were antibody-

negative at the time of donation.       

     FDA has been working closely with the blood industry to

minimize the burden of implementing this new screening test for

the approximately 14 million blood donations processed annually

in the United States.   

     The Coulter screening test kit will be marketed to blood

establishments by Ortho Diagnostic Systems Inc., a subsidiary of

the Johnson and Johnson Company, Raritan, N.J. 



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