All donations of whole blood and blood components collected in the U.S. and U.S. territories should be tested for Zika virus effective immediately, as per revised guidance issued today from the Food and Drug Administration (FDA).
Previously, blood donation testing for Zika virus was only recommended in areas with known active transmission. It was recommended that donated whole blood and blood components be screened for Zika virus, pathogen-reduction devices be used, or stop blood collection and obtain blood and blood components from areas without active virus transmission. Already, testing in Florida and Puerto Rico has shown the ability to identify Zika infected donations.
The update to their February guidance is following careful review of all available scientific evidence, consultation with other agencies, and consideration of potential serious health consequences of Zika virus to pregnant women and newborns.
“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,” said Peter Marks, MD, PhD, of the FDA in a press release.
At this time, screening may be conducted with a test authorized for use by the FDA under an investigational new drug (IND) application, or when available, a licensed test. For plasma and certain platelet products, an FDA-approved pathogen reduction device may be used.
The FDA say the new recommendations will be in place until the risk of transfusion transmission is reduced. Estimates suggest that 4 out of 5 people infected with the Zika virus never develop symptoms, highlighting the importance blood testing on reducing the number of possible transmissions.
The FDA’s chief scientist Luciana Borio, MD, said, “As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary.”
For more information visit FDA.gov.