America's Blood Centers Supports FDA Approval Of Nucleic Acid Testing

2/28/2002

From: Brooke Thaler of America's Blood Centers, 202-654-2915

WASHINGTON, Feb. 28 -- America's Blood Centers, an international network of community blood centers that collect nearly half of the U.S. blood supply and a quarter of the Canadian blood supply, applauds today's announcement from the U.S. Food and Drug Administration approving the licensure of NAT testing, a new gene-based, blood testing system which has been used in an FDA-approved study over the last three years to add an extra layer of safety when screening the blood supply for HIV and Hepatitis C.

America's Blood Centers' members began using NAT testing in 1999, when the FDA allowed its use under a research study called an Investigational New Drug protocol. The goal of this study has been to determine the effectiveness of NAT testing for wide scale use by the entire blood banking community. To date, seven HIV and 88 HCV positive blood samples have been detected using the new screening system.

"NAT testing has truly been a breakthrough for the blood banking community," said Celso Bianco, M.D., executive vice president and medical director of America's Blood Centers. "This is an important milestone because it now means this powerful research tool is officially recognized as improving blood safety. This is especially important for the 4.5 million Americans who receive life-saving blood transfusions every year. We are pleased that the FDA has licensed the test."

NAT testing has reduced the window period, or number of days between the time that a person contracts HIV or HCV and when the viruses can be detected using current FDA-approved antibody and antigen tests, called serological tests. Using serological tests, the window period for HIV is 16 days. With NAT, it is now 12 days. The window period for HCV using serological testing was about 72-82 days, but it is down to 25 days with NAT testing.

Members of America's Blood Centers have screened more than 30 million donations using NAT testing, which is conducted at 16 laboratories geographically dispersed nationwide. Approximately 35 percent of the blood collected by members of America's Blood Centers is screened by the Chiron Corporation test that today received FDA approval. The remainder is screened by Roche Diagnostics test under an FDA approved research protocol. The largest providers of blood products and services, America's Blood Centers' members are located in 45 states and Canada, serving more than 125 million people at 450 blood donation sites. For 40 years, America's Blood Centers' members have been committed to serving the needs of their local communities by saving lives through volunteer blood donation. Our members were also the first to respond to national tragedies like Oklahoma City, Columbine and September 11th.

For more information on America's Blood Centers or NAT testing, please call America's Blood Centers toll-free at 1-888-USBLOOD or visit our Web site at www.americasblood.org.