REGULATORY UPDATE: FDA Updates Syphilis Guidance for Blood and Blood Components

December 03, 2020

The Food and Drug Administration issued a new guidance on Dec. 2 with recommendations for screening, testing, and management of blood donors and blood and blood components based on screening tests for syphilis. The December 2020 guidance updates the guidance of the same title dated September 2014.

In the new guidance, FDA has: 

  • Revised the recommended deferral period following treatment for syphilis or gonorrhea to 3 months. 
  • Added a recommendation for reentry of donors with false positive screening test results who are subsequently determined to have never had a diagnosis of syphilis
  • Removed the recommendation for donors to provide written evidence of completion of syphilis treatment prior to reentry. 
  • Updated Code of Federal Regulation (CFR) citations to reflect current requirements. 
  • Made editorial or formatting changes.

The guidance provides background information describing syphilis as “rarely transmitted by transfusion of blood or blood components from donors with active syphilis,” noting the last reported case of transfusion-transmitted syphilis in the United States occurred in 1966. FDA also notes that a published study “suggests that some asymptomatic blood donors might have spirochetemia.” 

FDA provides a clear review of the current regulatory requirements and an overview of current testing options, including limitations that are addressed by the updated recommendations. FDA specifically notes that “Since both the nontreponemal and treponemal assays detect antibodies rather than the infectious treponemes themselves, neither assay reliably identifies patients in the ‘window period’ of very early syphilis, after infection has been acquired but before antibodies to either treponemal antigens or to cardiolipin have appeared.”
AABB encourages members to review Section IV, which includes flowcharts to map the recommendations for donor testing and management when using a nontreponemal screening test, page 8, and a treponemal screening test, page 11. Licensed blood establishments must report the implementation of these new recommendations to FDA in an annual report under 21 CFR 601.12(d), noting the date by which the process was implemented.  

AABB will provide more information on implementation on the Regulatory Toolkit web page as soon as possible to assist members with implementation strategies. This will include a change table that will track the revisions with a side-by-side comparison of recommendations in the 2020 guidance with those in the 2014 guidance. The Donor History Task Force, the Regulatory Affairs Committee and AABB Regulatory Affairs will conduct a detailed review of the recommendations to identify compliance issues and acceptable implementation strategies. 

Members with questions are invited to contact