Officials with the US Food and Drug Administration (FDA) are recommending universal testing of donated whole blood and blood components for Zika virus, according to a statement from the administration released today.
Last February, the FDA recommended that only areas with active Zika virus transmission screen donated blood for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain whole blood and blood components from areas of the United States without active virus transmission. This updated guidance recommends that all states and US territories screen blood 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.
Health officials in Florida and Puerto Rico are already testing donated blood, and officials with the FDA noted it has shown to be beneficial in identifying donations infected with Zika virus.
“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, the FDA’s acting chief scientist said in the statement. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the US blood supply.”
1. FDA advises testing for Zika virus in all donated blood and blood components in the US [press release]. Silver Springs, MD; United States. Food and Drug Administration: August 26, 2016.