August 26, 2016
Today, the FDA expanded its recommendation for Zika virus testing to include all donated whole blood and blood components acquired in the U.S. and its territories.
Prior guidance released in February recommended only that areas with active transmission screen donated blood products for the virus, or take steps to reduce the risk of contaminated blood. According to today’s revision, the agency now recommends all donations be screened using a licensed test, or one authorized for use by the FDA under an investigational new drug application. The guidance also advocates the use of an FDA-approved pathogen-reduction device for donated plasma and certain platelet products.