The U.S. Food and Drug Administration now strongly recommends testing the entire blood supply for Zika, given the uncertainty regarding the nature and extent of Zika virus transmission, according to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion,” Marks said in a release.

“It’s clear additional precautionary measures are necessary,” said an FDA scientist.

The FDA first recommended that only areas with active Zika virus transmission screen donated whole blood and blood components for Zika virus. Other recommendations are to use pathogen-reduction devices, or halt blood collection and obtain whole blood and blood components from areas of the U.S. without active virus transmission — but that was back in February.

The revised guidance announced today recommends all states and U.S. territories screen individual units of donated whole blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The updates, health officials said, come “after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.”

Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and has shown to be useful in identifying donations infected with Zika virus. The recommendations will remain until the risk of the transmission of the Zika virus is reduced.

“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.”

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