Food and Drug Administration Recommends Zika Testing for Donated Blood
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Food and Drug Administration Recommends Zika Testing for Donated Blood

The agency is updating its original recommendation for testing only areas where Zika was active

August 26, 2016

The Food and Drug Administration (FDA) has issued a revised guidance that recommends universal Zika testing for all donated whole blood and blood components in the U.S. and its territories.

"There is still much uncertainty regarding the nature and extent of Zika virus transmission," said 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."

The FDA's original guidance was issued on February 16. It recommended that only those areas where Zika was being actively transmitted should test donated blood for the virus, use pathogen-reduction devices, or stop collecting blood and obtain donations from areas in the U.S. where the virus was not being actively transmitted. All the areas in the U.S. where Zika is being actively transmitted currently comply with this recommendation.

According to the FDA's press release, the updated guidance recommends that "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, a pathogen-reduction device approved by the FDA can be used for certain plasma and platelet products.

The agency decided to issue an updated recommendation after carefully considering all the available scientific evidence, consulting additional public health agencies, and considering the potentially serious consequences of infection on the health of pregnant women and children born to women who were exposed to Zika when they were pregnant.

"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."

Florida and Puerto Rico, among other areas, are already testing donated blood, and this has helped to identify donations of blood infected with Zika. Expanding the testing will help reduce the risk of transmission of the virus even further and will continue until there is less risk of transmitting the virus by blood transfusion.

The Zika virus is transmitted mainly by the Aedes mosquito, but it can also be transmitted through sexual contact. While four out of five infected people never develop symptoms, consumers should still be aware of them in case they do occur: fever, joint pain, maculopapular rash (a red area with small bumps), and red, irritated eyes. Infection during a woman's pregnancy can result in serious birth defects and is also associated with additional adverse outcomes of the pregnancy.