Washington, DC - 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.
