What are the FDA guidelines for reducing the risk of transmission of Zika virus via blood products?

Updated: Dec 11, 2018
  • Author: Bhagyashri D Navalkele, MD, MBBS; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

In August 2016, the FDA revised its guidelines for reducing the risk of Zika virus transmission via blood and blood components. The key recommendations included the following: [31]

  • All blood donations should be tested with an investigational individual donor nucleic acid test (ID-NAT) for Zika virus under an investigational new drug application (IND) or, when available, a licensed test
  • Implement pathogen reduction technology for platelets and plasma using an FDA-approved pathogen-reduction device
  • Providing donor educational material with respect to Zika virus and screening donors for Zika virus risk factors, such as travel history, and deferring them as previously recommended in the February 2016 guidance is no longer necessary
  • If a potential donor volunteers a recent history of Zika virus infection, blood or blood components should not be collected. The donor should be deferred for 120 days after a positive viral test or the resolution of symptoms, whichever timeframe is longer.
  • ID-NAT–nonreactive donations may be released provided all other donation suitability requirements are met
  • ID-NAT–reactive donations may not be used
  • Defer a donor who tests ID-NAT reactive for 120 days from the date of the reactive test or after the resolution of Zika virus symptoms, whichever timeframe is longer. Notify donors of the deferral and counsel them regarding possible Zika virus infection.
  • Quarantine and retrieve blood and blood components collected 120 days prior to the donor's ID-NAT–reactive donation. If the prior blood components were transfused, advise the transfusion service to inform the transfusion recipient’s physician of record regarding the potential need for monitoring and counseling the recipient for possible Zika virus infection.

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