FDA announces revised guidance on the testing of donated blood and blood components for Zika virus

July 6, 2018

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“One of the FDA’s critical public health responsibilities is ensuring the safety of the nation’s blood supply. To help protect the blood supply from infectious diseases, the FDA continually assesses the latest scientific information available to ensure that our blood deferral and testing recommendations best safeguard the millions of people who depend on blood donations every year,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today we are announcing that we have revised our recommendations for testing blood donations for the Zika virus. When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply. Now, given the significant decrease in cases of Zika virus infection in the U.S. and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

Today the FDA announced the availability of a revised final guidance: “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” This revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing for Zika virus of individual units of blood donated in the U.S. states and territories. The revised guidance explains that, in order to comply with applicable testing regulations, blood establishments must continue to test all donated Whole Blood and blood components for Zika virus using a nucleic acid test. The revised guidance explains the basis for the FDA’s determination that pooled testing of donations using a screening test licensed for such use by the FDA is a sufficient method for complying with these regulations and effectively reducing the risk of Zika Virus transmission, unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in that location. Alternatively, blood establishments may use an FDA-approved pathogen-reduction device for plasma and certain platelet products.

The change comes after careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee. The agency is confident that today’s recommendations will continue to ensure the safety of the U.S. blood supply by reducing the risk of transmission of Zika virus, while reducing the burden of testing for blood establishments.

Zika virus is transmitted primarily by the Aedes mosquito, but it can also be spread by other routes, including by blood and sexual contact. Many people infected with the virus never develop symptoms, however when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). Zika virus can also be associated with Guillain-Barre syndrome and severe neurological complications. Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.