Joint Statement Before the Blood Products Advisory Committee
T. cruzi Incidence Study in Blood Donors and Its Implications for Selective Testing of Blood Donors
02 August 2011
M. Allene Carr-Greer, Director, Regulatory Affairs, AABB
Recommendations in the December 2010 Guidance for Industry "Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion" are summarized as follows:
- Ask all presenting allogeneic donors if they have a history of Chagas' disease.
- Test each allogeneic donor one time for antibodies to T. cruzi and allow donors with nonreactive results to donate without further testing of subsequent donations for antibodies to T. cruzi.
A yes response to the question or a repeat reactive result using an FDA licensed test will result in the donor being indefinitely deferred.
We believe the data presented today – zero observed incidence in the 4-year study conducted by the American Red Cross and Blood Systems Research Institute (6 million plus person years of observation of 4.22 million donors) – supports the ongoing one-time testing to qualify allogeneic donors for repeat donation as recommended in the 2010 guidance.
Retesting test-negative donors following a defined period of time such as two or five years adds no value relative to the low risk of incidence and infrequent occurrence of transfusion transmission.
We see no value to asking donors if they have ever had Chagas' disease and suggest a withdrawal of this particular guidance document recommendation.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
Founded in 1962, America's Blood Centers is North America's largest network of community-based blood programs. Seventy-five blood centers operate more than 600 collection sites in 45 U.S. states and Canada, providing half of the United States, and all of Canada's volunteer donor blood supply. These blood centers serve more than 180 million people and provide blood products and services to more than 4,200 hospitals and health care facilities across North America. ABC's U.S. members are licensed and regulated by the U.S. Food & Drug Administration. Canadian members are regulated by Health Canada.
The American Red Cross, through its 36 Blood Services Regions and five National Testing Laboratories, supplies more than 40% of the nation's blood supply. Over six million units of whole blood were collected from nearly four million Red Cross volunteer donors, separated into 9.5 million components, and supplied to approximately 3,000 hospitals and transfusion centers to meet the needs of patients last year.