News
11/29/1988

<TITLE>HTLV-I Test Kits Approved </TITLE>
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HTLV-I Test Kits Approved 

P88-36                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285 

    The Food and Drug Administration today approved three tests for the 
detection of antibodies in blood to a retrovirus called Human T-Lymphotropic
Virus Type I, or HTLV-I, which has been linked to a rare leukemia.
    HTLV-I is a distinct retrovirus associated with a leukemia called Adult 
T-cell lymphoma which may appear in a small number of virus-infected
individuals 20 to 40 years after they are infected.  HTLV-I has been
separately associated with a degenerative neurologic disease called tropical
spastic paraparesis.  Both diseases are rare in the United States.
    Because there is evidence this virus is transmitted through blood 
products, FDA today recommended that blood banks screen donated whole blood 
and cellular blood components.  FDA advised that blood banks should 
quarantine and destroy units of blood that are determined to be reactive to 
the tests.  Furthermore, FDA advised that donors should be deferred when
follow-up tests confirm antibodies to HTLV-I or when the donor has a
repeatably reactive screening test on more than one donation. 
    FDA Commissioner Frank E. Young, M.D., Ph.D., said, "Based on current 
data we know that HTLV-1 is rare in the United States, but to be on the safe
side, FDA has recommended blood screening.  If blood tests positive, it will
not be entered into the blood supply."
    In its recommendations, FDA asked that blood banks consider notifying 
and counseling donors whose blood has tested positive by both the HTLV-I
screening test and follow-up tests.  FDA further said that the new tests can
not reliably distinguish between antibodies to HTLV-I and HTLV-II, another
retrovirus whose ability to cause disease is unknown.  Deferred donors
should be told not to share needles for injections, should be discouraged 
from breast feeding infants and should be counseled about sexual activities.
    An American Red Cross study in several regions showed that the
prevalence of HTLV-I in U.S. blood donors is about two donors out of 10,000.
    Most HTLV-I positive individuals in this country have been identified in
the rural south.  However, the virus has been detected in intravenous drug
users in New Orleans, New York City, Miami and Atlanta. 
    HTLV-I infections are common in the Pacific rim countries, the Caribbean
basin and Africa. 
    The companies licensed for the new test are:  E.I. du Pont De Nemours & 
Co. Inc. of Wilmington, Del. together with Biotech Research Laboratories of 
Rockville, Md.; Abbott Laboratories of North Chicago, Ill.; and Cellular
Products Inc. of Buffalo, N.Y.
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