Licensure of New Technology Enhances American Red Cross Blood Safety Efforts

American Red Cross
Thursday, 28 February 2002

Approved Nucleic Acid Testing Contributes to an Even Safer Blood Supply

The American Red Cross today learned of the Food and Drug Administration's announcement to license the Chiron Procleix assay for Nucleic Acid Testing (NAT). The Red Cross uses this technology designed to detect the genetic material of HIV-1 and hepatitis C virus (HCV) even earlier after infection than previously approved serologic tests.

"Our top priority is ensuring a safe and available blood supply for the patients we serve," said Dr. Jerry Squires, vice president and chief scientific officer. "This technique further builds upon today's extremely safe blood supply. NAT is another layer of safety that helps assure patients they receive the safest possible products."

In the United States, blood is needed every two seconds. The Red Cross must collect 25,000 blood donations every day to meet the needs of patients, including accident victims, trauma patients and children with diseases such as leukemia or sickle cell anemia. The Red Cross encourages all eligible blood donors to call 1-800-GIVE-LIFE to schedule an appointment and help join in the mission to save lives.

In March 1999, the American Red Cross launched NAT for two infectious disease agents, HIV-1 and HCV, under an investigational new drug protocol. Today, the Red Cross tests every allogeneic blood donation using NAT, which is conducted at five Red Cross NAT laboratories, co-located with the Red Cross National Testing Laboratories in San Diego, Detroit, St. Louis, Charlotte and Philadelphia. The Red Cross uses the licensed Chiron Procleix HIV-1/HCV assay, which was licensed by the FDA on February 28, 2002.

NAT can detect the genetic material of transfusion-transmitted viruses without waiting for the body to form antibodies, therefore often offering an important time advantage over current techniques. A small sample of the donor's blood is pooled with 15 other blood donation samples. The pooled samples are prepared in a way so as to separate any genetic material associated with the HIV-1 or HCV. The sample is further processed so that multiple copies are made of any viral material present. A laboratory test can then be used to detect this evidence of viral infection. For more information about NAT, visit http://www.redcross.org/services/biomed/blood/supply/nucleic.html.

About the American Red Cross

The American Red Cross is dedicated to saving lives, easing suffering and restoring hope at home and around the world. Currently operating on a budget of $2.7 billion, the Red Cross annually mobilizes relief to the victims of more than 67,000 disasters nationwide and has been the primary supplier of lifesaving blood and blood products in the United States for more than 50 years. In 2000, the Red Cross also trained almost 12 million people in vital lifesaving skills and delivered more than 21 million locally relevant community services. The organization also assisted international disaster and conflict victims in close to 40 locations around the globe, and its emergency communication centers processed 1.2 million calls in support of U.S. military families.

For more information, or to contact American Red Cross, see their website at: www.redcross.org