Overview
Chagas’ disease, a serious and potentially fatal infection, is caused by Trypanosoma cruzi, a blood-borne parasite. Millions of people in Latin America carry the T. cruzi parasite and thus serve as a source of infection in the transfusion setting. Some experts estimate that there may be as many as 100,000 legal immigrants in the U.S. and Canada who are unknowingly infected with T. cruzi.
Although only a few cases of blood transfusion- or organ transplantation-transmitted cases have been reported in the U.S., it is well-accepted that many other cases have occurred but have not been recognized. Donor screening questions have not been shown to successfully identify risk in U.S. blood donors. The FDA has approved two blood donor screening tests but has not yet required that donors be screened for antibodies to T. cruzi. Many blood centers voluntarily test blood donors, and AABB has established the Web-based Chagas’ Biovigilance Network to track the results of the testing (screening as well as confirmatory results).
On behalf of the transfusion medicine and cellular therapies community, AABB works directly with the FDA or through government advisory committees as part of ongoing, collaborative efforts to protect against the transmission of T. cruzi through blood and human cells, tissue, and cellular- and tissue-based products. In addition, AABB provides guidance to establishments while working with public health officials to monitor infection outbreaks.
Recent Actions
12/6/10
FDA publishes guidance on the use of serological tests to reduce the risk of T. cruzi infection transmission in whole blood and blood components intended for transfusion.
4/30/10
FDA approves a second test, Abbott Prism Chagas, to screen blood, tissue and organ donors for the blood-borne parasite T. cruzi.
8/14/09
An updated version of the Hematopoietic Progenitor Cell Donor History Questionnaire includes a revised question to better evaluate an allogeneic HPC donor for a history of a positive test for Chagas’ disease.
4/1/09
FDA Blood Products Advisory Committee endorses a selective strategy to test blood donors for T. cruzi.
Archived Actions