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

摘要

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.