Technology Offers Potential to Further Protect U.S. Blood Supply
Washington, DC, April 8, 1999 -- The American Red Cross is pioneering the use of an innovative technology that could add an additional layer of safety to the 14 million units of blood components distributed by the Red Cross to hospitals nationwide each year. The Red Cross is investigating a new genetic test, nucleic acid testing or NAT, for the early detection of transfusion-transmitted viruses, such as HIV and Hepatitis C Virus (HCV), at its National Genome Testing Laboratory in San Diego, Calif. Already the Red Cross' use of NAT has detected the first unit of HCV-infected donor blood that was negative by standard screening tests, thus preventing a probable transmission of the disease.
The Red Cross has been the leader in bringing NAT technology to blood screening and began evaluating NAT under an Investigational New Drug (IND) application approved by the Food and Drug Administration (FDA) in January 1999. Initially the Red Cross performed unlinked testing, severing the link between the donor and sample, to validate the processes and systems newly created for NAT. Red Cross tested more than 180,000 samples during unlinked testing.
Based on favorable test outcomes, the Red Cross began screening blood donations with NAT at the National Genome Testing Laboratory under the FDA-approved IND in early March 1999. The Red Cross expects to fully implement NAT under the IND in all of its blood centers by June 1999.
"While the U.S. blood supply is already safer than it ever has been and current
screening tests are very sophisticated, this innovative technology has the
potential to enable the detection of dangerous viruses in donors whose own
immune systems have not yet recognized the presence of an infectious agent,"
says Brian McDonough, chief operating officer, American Red Cross Blood
Services. "This new screening method is expected to provide more accurate and
Contact: Ernie Knewitz