FDA Revises Recommendations for Testing Donated Blood for Zika

The Food and Drug Administration has issued final guidance revising its recommendations for testing donated whole blood and blood components for Zika virus. The guidance recommends that establishments collecting whole blood and blood components test all donations collected in the U.S. and its territories using minipool (MP) or individual donation nucleic acid testing, or collect and prepare blood components using pathogen reduction technology with an FDA-approved pathogen-reduction device. The guidance also recommends that establishments using MP NAT convert to ID NAT if screening identifies a Zika-reactive donation or public health authorities identify an increased risk for Zika transmission in the area. FDA previously recommended using ID NAT for all blood donations or pathogen reduction for indicated blood components. The agency said it expects the new recommendations “to adequately and appropriately detect early infections in an outbreak, while reducing the burden of ID NAT testing.”