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Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus – Guidance for Industry

The FDA issued the original Guidance for the mitigation of the transmission of Zika Virus in February 2016 with a revised version issued in July 2018 for immediate implementation.1 

The FDA has provided the following recommendations in this document:

  1. Test all donations collected in the US and its territories with a licensed NAT for ZIKV, using either MPNAT or ID NAT according to manufacturer’s instructions in the package insert/

OR

  1. As an alternative to ID NAT testing, blood establishments may use FDA-approved pathogen reduction technology for indicated blood components (i.e. platelets) to reduce the risk of ZIKV transmission by blood and blood components. (21 CFR 610.40(a)(3)(ii)(B)). Published studies support the effectiveness of pathogen reduction methods against IKV for platelets.2,3

  1. FDA, Revised Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus. FDA Guidance for Industry, July 2018.
  2. Aubry, M., et al., “Inactivation of Zika Virus in plasma with Amotosalen and ultraviolet A illumination.” Transfusion. 2016 Jan; 56(1):33-40 doi 10.1111/trf.13271
  3. Santa Maria, F. et al., “Inactivation of Zika Virus in platelets with amotosalen and ultraviolet A illumination.” Transfusion 2017; 57:2016-2025.

Additional Resources

Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components - Guidance for Industry (July 2018)

Download the Guidance - pdf
(Links to FDA website in a new page)