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For Immediate Release: March 27, 2012
Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves additional blood test for viruses linked to leukemia, neurologic diseases

Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.

Avioq HTLV-I/II Microelisa System, is the only test now available that can be used to both screen the blood supply for antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II), and help diagnose infection with these viruses.

Both HTLV-I and HTLV-II can be transmitted through transfusion, reuse of syringes, and by breast feeding from infected mothers. Screening of all blood donors in the U.S for evidence of HTLV infections is required to assure the safety of blood transfusions. 

The Avioq HTLV-I/II Microelisa System is intended for screening living individual human donors, including volunteer donors of whole blood and blood components for the presence of HTLV antibodies. It is also approved for testing serum and plasma specimens to screen potential organ donors when specimens are obtained while the donor’s heart is still beating. It is not intended to be used to screen cord blood specimens.

Additionally, the test is approved for use as an aid in the diagnosis of HTLV-I or HTLV-II infection and related diseases.

“Since 2008, there has been only one FDA-licensed donor screening test available for detection of antibodies to HTLV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides an additional test for HTLV, providing greater flexibility to blood establishments and helping to assure the safety of the blood supply.” 
 
The Avioq HTLV-I/II Microelisa System can be used manually or with an automated screening system, the ORTHO Summit System.

The Avioq HTLV-I/II Microelisa System is manufactured by Avioq Inc., Research Triangle Park, N.C.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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