FDA Recommendations for Syphilis Screening of Blood and Blood Components

The FDA published a Draft Guidance for Industry on "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis".

This draft guidance replaces FDA's draft guidance entitled, "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis," dated June 2003 (Ref. 1).When finalized, it will supersede the memorandum of December 12, 1991, entitled "Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing" (Ref. 2).

The last case of a transfusion related transmission of Syphillis in USA was reported in 1966. One important factor for avoiding transfusion transmitted Syphilis was the preventative screening of donors and blood components. Further factors were the abandonment of direct donor-to-recipient transfusions as well as inactivation steps during preparation and storage.

Information from the American Red Cross serological testing of donors revealed that there were 324 cases of syphilis infections among American Red Cross repeat allogeneic donors in 2007-2008. This figure is several times higher than the numbers of repeat allogeneic donors identified with other diseases like HIV or HBV. Several published studies reporting the presence or absence of Treponema pallidum nucleic acid in blood samples from individuals with confirmed or possible syphilis detected spirochete nucleic acid in blood samples from persons with syphilis, some of whom had a latent infection with no symptoms. This suggests that some asymptomatic blood donors might have spirochetemia. Donations from such blood donors may have the potential to transmit syphilis to recipients.

Please also see the complete draft entitled "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis".