Standards & Policies
FDA Guidance on Babesia:
Recommendations For Reducing The Risk Of Transfusion-Transmitted Babesiosis – Final Guidance For Industry
The FDA issued the original guidance for the mitigation of the transmission of babesia in July 2018 with a final version issued in May 2019 for immediate implementation.1
The FDA has provided the following recommendations in this document:
- Regional, year-round testing using NAT or PRT in high risk states (Massachusetts, Rhode Island, New York, New Jersey, Minnesota, Wisconsin, New Hampshire, Maine, Maryland, Washington DC)
- A two year deferral following a reactive NAT test.
- The Donor History Questionnaire may be modified such that questions asking donors about their history of babesiosis can be discontinued when NAT or PRT is performed.
Background on NAT products approved in US
- In 2018, FDA approved two tests manufactured by Imugen that have since been permanently discontinued: Arrayed Fluorescent Immunoassay and a NAT test.
- As of January 2019, FDA licensed the Grifols Procleix Babesia NAT in whole blood specimens for use in whole blood and blood components.
- As of September 2019, FDA licensed the Roche cobas® Babesia test for whole blood specimens.
Product Management, Retrieval, Notification with Positive NAT, not applicable to Pathogen Reduced Products
- If a donation is NAT reactive all components previously collected by the same donor needs to be identified, retrieved and quarantined.
- Consignees of identified components need to be notified; if the infectious component was transfused, physicians involved should be notified.
“The recommendation for consignee notification and retrieval does not apply to previously distributed cellular blood components that were pathogen reduced using an FDA-approved device according to its instructions for use.”