Whats up with Chagas Blood Donor testing?
. I. INTRODUCTION Page Last Updated: 12/07/2010 We, FDA, are issuing this guidance to notify you, establishments that manufacture Whole Blood and blood components intended for transfusion, about FDA approvals of Biologics License Applications (BLAs) for serological test systems for the detection of antibodies to Trypanosoma cruzi (T. cruzi). These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. This guidance does not apply to establishments that make eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Also, this guidance document does not apply to the collection of Source Plasma. In addition, we are providing you with recommendations for testing donations of Whole Blood and blood components for evidence of T. cruzi infection, blood donor and product management, labeling of W
