Updated FDA Guidance on Zika Screening Posted
May 3, 2018
On May 2, 2018, the FDA posted an updated guidance outlining donor screening recommendations aimed at reducing the risk of transmission of Zika Virus by HCT/Ps.
This guidance updates the information published in the March 2016 guidance by:
- Providing findings from more recent epidemiological studies including impact on public health;
- Reporting new data that informs the potential for transmission of ZIKV;
- Discussing the current status of availability of ZIKV tests;
- Updating sexual contact risk factors;
- Updating the criteria for considering an area to have an increased risk for ZIKV transmission; and
- Providing additional scientific references.
This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk.
FDA recommends that you implement the recommendations in this guidance as soon as feasible, but not later than 4 weeks after the guidance issue date.