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Nucleic acid-amplification testing further safeguards nation's blood supply

State-of-the-art testing systems to screen donated blood have improved the safety of the nation's blood supply by preventing the transmission of potentially deadly viruses, according to a new study funded by the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health. Nucleic acid-amplification testing (NAT) has helped prevent the transmission of approximately five HIV-1 infections and 56 hepatitis C virus (HCV) infections each year since it began being used in the United States as an investigational screening test in mid-1999. The study is published in the August 19 issue of the New England Journal of Medicine.

"Risks to blood recipients from transfusion-transmitted viruses such as HIV and hepatitis are already extremely low, in part because of increased surveillance and improved testing," said Barbara Alving, M.D., NHLBI acting director. "NAT enhances the safety of the nation?s blood supply by further reducing these risks."

The study is the first and only one of its scope to show the effectiveness of the NAT assay system nationally. All major blood donation laboratories in the United States participated, accounting for more than 98 percent of tested blood donations. Many organizations collaborated on the research, including the American Red Cross, Blood Systems Research Institute, America's Blood Centers, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention.

The study investigators analyzed all donations that detected ribonucleic acid (RNA) from HIV-1 and HCV by NAT between 1999 and 2002. The researchers then looked to see which of these infected donations had been missed by tests to detect viral antibodies or antigens (proteins from the virus), the types of screening previously used. They concluded that NAT reduced the risk of HIV-1 and HCV infections associated with blood transfusion to approximately 1 in 2 million blood units. In comparison,
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Contact: NHLBI Communications Office
NHLBI_news@nhlbi.nih.gov
301-496-4236
NIH/National Heart, Lung, and Blood Institute
18-Aug-2004


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