FDA recommends universal testing of donated blood for Zika

The Food and Drug Administration today recommended universal testing of donated whole blood and blood components for Zika virus in the U.S. and its territories. “As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.” The guidance recommends screening individual units of donated whole blood and blood components with a test authorized by the agency for use under an investigational new drug application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products. The first cases of locally transmitted Zika in the continental U.S. were reported last month in Miami-Dade County, FL. Testing of donated blood is already underway in Florida, Puerto Rico and other areas, and has shown to be beneficial in identifying Zika-infected donations, FDA said. Zika can cause microcephaly and other birth defects in infants born to women infected during pregnancy. This week, Johns Hopkins Medicine opened a center dedicated primarily to caring for patients with the mosquito-borne and sexually transmitted virus. For more information on Zika, visit http://www.cdc.gov/zika and http://www.aha.org/zika.