The U.S. Food and Drug Administration (FDA) has published a final guidance en-titled, “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.” The guidance recommends that babesiosis is a relevant transfusion-transmitted infection (RTTI) 21 CFR 630.3(h)(2)(i) and (ii) but does not recom-mend year-round antibody testing in Babesia endemic states at this time due to the lack of an available antibody test.
The FDA’s Blood Products Advisory Committee previously recommended nation-wide year-round antibody screening of donors in addition to nucleic acid testing (NAT) in high risk states. Currently, the Grifols Procleix Babesia Assay for the detection of RNA from Babesia species is the only FDA licensed test available for the screening of whole blood and blood component tests. The previously available FDA licensed Imugen B. microti antibody test and Imugen B. microti NAT have been discontinued by the manufacturer.
This contributed to the FDA’s recommendation of regional year-round testing of all donations collected in the states below “using a licensed NAT for Babesia, or FDA approved pathogen reduction device”:
• New Hampshire
• New Jersey
• New York
• Rhode Island
• Washington, D.C.
Additionally, the guidance recommends that blood centers in states not subject to Babesia testing and whose products are not pathogen reduced must revise their donor history questionnaire to ask donors if they have ever had a positive test for Babesia, either as a medical diagnosis or donor screening. Those individuals with reactive Babesia NAT results are deferred for a period of at least 2 years from the date of the test. Donors must be notified and counseled on the potential significance of the results. Donor questions regard-ing history of babesiosis may be discontinued when testing or pathogen reduction is performed. Individuals previously deferred for a history of babesiosis may be eligible for reentry.
Products from donations that test reactive for Babesia must not be used for transfusion. The Circular of Information must be updated to indicate when testing for Babesia is performed. More information and the full guidance are available on the FDA’s website.
The recommendations in the guidance may be implemented as soon as feasible but no later than 12 months after the guidance issuance date, which would be May 9, 2020.
The guidance finalizes the July 2018 draft guidance, which America’s Blood Centers (ABC) submitted comments to FDA on behalf of its member blood centers. Additionally, ABC joined AABB and the Amer-ican Red Cross in the submission of joint comments. Babesia donor testing began in August 2012 in certain endemic areas under investigational new drug applications. Most individuals that become infected with B. microti are asymptomatic, while others display flu-like symptoms.
Source: FDA Guidance, 5/9/19