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. More information is available by reading the Trypanosoma cruzi Fact Sheet located on the AABB Emerging Infectious Diseases web page.
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 recommends that allogeneic donors should be tested at least one time using a licensed test for antibodies to T. cruzi. Donors who test nonreactive are qualified to return to donate without further testing of subsequent donations. 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.
AABB posted an analysis of “Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Guidance for Industry” published by Food and Drug Administration on December 6. This guidance supersedes the October 2010 guidance of the same name and finalizes the draft guidance “Amendment to ‘Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion;’ Draft Guidance for Industry” dated November 2016.
AABB, America’s Blood Centers and the American Red Cross provided comments to the Food and Drug Administration (FDA) on the draft guidance titled “Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood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”. These comments were prepared by a working group of member experts from AABB’s Donor History Task Force and Transfusion Transmitted Diseases Committee.