Important note: Information in this article was accurate in 1988. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - November 29, 1988
Susan Cruzan - (301) 443-3285
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.
881129
FD881102
SOURCE: Food and Drug Administration (FDA).
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