Notice: Revised FDA Guidance for Testing Donated Blood and Blood Components for Zika Virus

PUBLISHED: Jul 6, 2018
Relevant to: Clinical Lab, Critical Access Hospitals, Hospitals, Pharmacy

The U.S. Food and Drug Administration has released revised final guidance: “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” This revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing for Zika virus of individual units of blood donated in the U.S. states and territories.

The revised guidance explains that, in order to comply with applicable testing regulations, blood establishments must continue to test all donated Whole Blood and blood components for Zika virus using a nucleic acid test. The revised guidance explains the basis for the FDA’s determination that pooled testing of donations using a screening test licensed for such use by the FDA is a sufficient method for complying with these regulations and effectively reducing the risk of Zika Virus transmission, unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in that location. Alternatively, blood establishments may use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

According to the FDA, the change comes after careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.

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