In a recently published article in Transfusion (Aug., 2001) entitled: Syphilis, a disease of direct transfusion*, the author, Dr. Paul J. Schmidt of Tampa, FL, comments "that despite the national decline and control of syphilis; despite the availability of penicillin; despite the fact that direct donor-to-patient transfusion, which was the vehicle for the transfer of syphilis, is no longer done; despite the fact that it has been accepted for 50 years that the serologic test for syphilis becomes positive only after the spirochete is probably no longer in the blood; despite the fact that 35 years have passed since a recorded case of transfusion-transmitted syphilis; and despite the evidence that syphilis screening is not helpful in the prevention of posttransfusion AIDS, the testing of all blood components still continues". He implies that there is no longer a valid motive for continuing to test blood donors to prevent post-transfusion syphilis, which he calls a nonexistent disease.

* For visitors who are not AABB members, a PDF version of the above article is available on the CBBS web site (courtesy of AABB and the editor of Transfusion), but it is quite large (over 1.2 MB) and would take some time to download via a standard 56k modem connection. Alternatives include the original journal issue.)

The following comments have been received.

ADDENDA Jan. 30, 2005

1. A colleague affiliated with a national blood donor collection network in the United States reports that in her opinion the discontinuation of syphilis testing is not an option for US blood centers at this time, because syphilis testing is required as a donor-screening test according to the Code of Federal Regulations: 21 CFR 610.40(i). Prior to finalization of the latest round of infectious disease testing requirements that were codified in the CFR, she reports that the FDA inquired of blood collection organizations if there were data supporting elimination of syphilis testing. A set of data were reported in 2002 by Orton and colleagues in Transfusion (Prevalence of circulating Treponema pallidum DNA and RNA in blood donors with confirmed-positive syphilis tests) which showed that blood donors with confirmed-positive results in a serologic test for syphilis were unlikely to have circulating T. pallidum in their blood, and that their blood was unlikely to be infectious for syphilis. She has recently spoken to colleagues familiar with the regulatory scheme in the US, and is of the opinion that the FDA remains unconvinced by the available data, and that no plan has been presented to sway the FDA to reconsider.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator