FDA Allows New Test to Screen Blood Donations for Zika Virus

Areas with active transmission may conduct local collections if a licensed test for screening donation is available
Areas with active transmission may conduct local collections if a licensed test for screening donation is available

The Food and Drug Administration (FDA) announced the availability of an investigational test by Roche Molecular Systems to screen blood donations for Zika virus. The test may be used to screen blood donations in areas with active mosquito-borne Zika virus transmission. 

In February, the FDA guidance on reducing the risk of transfusion-transmitted Zika virus recommended that areas with active Zika virus transmission obtain whole blood and blood components from areas without active Zika virus transmission. Following this recommendation, local blood collection in Puerto Rico was suspended. The Department of Health and Human services announced on March 7 that shipments for blood products have been arranged from the continental U.S. to Puerto Rico. 

RELATED: CDC Makes Recommendations to Prevent Zika Transmission in Health Care Settings

Further, the guidance stated that establishments in areas with active transmission may conduct local collections if a licensed or investigational test for screening donated blood is available. Puerto Rico will be able to resume collecting whole blood and blood component donations once screening using the investigational test commences. 

The FDA and other agencies are working to help manufacturers develop Zika virus blood donation screening tests to help preserve the country's supply of blood and blood components during this outbreak. 

For more information visit FDA.gov.

Loading links....