The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. The test is manufactured by Roche Molecular Systems, Inc., based in Branchburg, New Jersey.
On Feb. 16, the FDA issued guidance to blood establishments to reduce the risk of transfusion-transmitted Zika virus. In the guidance, the FDA recommends that areas with active transmission of Zika virus obtain Whole Blood and blood components from areas without active transmission of Zika virus. As a result of this recommendation, local blood collection in Puerto Rico was suspended, and on March 7, the Department of Health and Human Services announced that it arranged for shipments of blood products from the continental U.S. to Puerto Rico.
The FDA guidance further states that establishments in areas with active Zika transmission may collect locally if a licensed or investigational test for screening donated blood is available. Once screening of blood donations for Zika virus using the investigational test begins, blood establishments in Puerto Rico may resume collecting donations of Whole Blood and blood components.
The FDA, the Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority, and the Centers for Disease Control and Prevention are working to assist product manufacturers with development of Zika virus blood donation screening tests to help protect the nation’s supply of blood and blood components during this outbreak.
