FDA Releases Revised Guidance on Zika Virus Testing
The U.S. Food and Drug Administration (FDA) has released a revised guidance regarding Zika virus testing, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” The revised guidance recommends universal testing of donated whole blood and blood components for Zika virus in the United States and its territories. The revised guidance supersedes the earlier guidances containing recommendations for blood components regarding Zika virus that were issued by FDA in February and March.
As described in today’s revised guidance, FDA now recommends testing of all donated whole blood and blood components in the United States and its territories with an individual donor nucleic acid test (ID-NAT) under an investigational new drug application or with a licensed screening test, once one becomes available. Additionally, blood collection institutions may use FDA-approved pathogen reduction technology for plasma and certain platelet products.
According to FDA, the new recommendations for ID-NAT testing should be implemented in phases based on location during the next 12 weeks. Blood collection establishments in states and territories with one or more reported locally acquired mosquito-borne cases of Zika virus should implement the recommendations immediately. Screening of all whole blood and blood components with investigational donor screening tests is already underway in Florida and Puerto Rico.
The second phase affects locations in which there is an increased risk for Zika virus transmission through the blood supply, based on proximity or epidemiologic linkage to areas with locally acquired mosquito-borne cases of Zika virus. These locations include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas. In these locations, the new recommendations should be implemented as soon as feasible but not later than four weeks after the guidance issue date.
Blood collection establishments in all other states and territories should implement the recommendations as soon as feasible but not later than 12 weeks after the guidance issue date.
According to FDA, these recommendations will remain in place until there is sufficient evidence to determine that the risk for transfusion-transmission of Zika virus has changed. Additionally, since all donated whole blood and blood components will now be screened for Zika virus, FDA is no longer recommending that blood establishments provide donor educational material or defer donors with risk factors for Zika virus. These activities may be discontinued once the recommendations for testing or pathogen reduction are implemented.
Implementing these changes does not require prior approval. Licensed establishments should update their annual reports.
AABB members are urged to carefully review the new FDA guidance for additional recommendations. In addition, AABB members are advised to visit AABB’s
Zika Virus Biovigilance Network, which tracks and maps locations where donated blood has tested positive for Zika virus.