FDA Releases Draft Guidance on Serological Tests for Trypanosoma cruzi Infection

Summary

The Food and Drug Administration (FDA) has made available a draft document outlining the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components for transfusion and human cells, tissues, and products. The guidance provides recommendations for the detection of antibodies to T. cruzi and notifies establishments about FDA approval of a biologics license application for an ELISA test system.