Management of donors who are repeat reactive on Treponema pallidum specific antibody tests but non-reactive on enzyme immunoassay or other fluorescent treponemal antibody confirmatory tests

A senior medical technologist at a hospital based Collection and Transfusion service in the Northeast asks "What do Blood Centers do regarding donor management when the donor is repeat reactive on Treponema pallidum specific antibody tests (such as PK-TP) but non- reactive on enzyme immunoassay (such as CAPTIA Syph-G) or other fluorescent treponemal antibody (FTA) confirmatory tests?" He adds that an RPR is not performed in this case.

Editors' note: The FDA draft guidance Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis is germane to this discussion.

The following comments have been received.

ADDENDA July 27, 2007

1. According to the Director of Special Donor and Community Health Services at a blood center in New York, donors who are RR in a non-treponemal assay for Syphilis but are negative on confirmation testing are not required to be deferred. She directs us to see point 3 in the 12/12/91 memorandum clarifying donor deferral for syphilis. This is unchanged in the 2003 draft guidance as demonstrated in the flow charts.

ADDENDA Aug. 27, 2007

2. Colleagues at the Israeli National Blood Services (Magen David Adom) are reevaluating their reentry protocol and guidelines for notification of blood donors with positive TPHA results. They comment that from the question recently raised in the CBBS e-Network Forum that the recommendations of the FDA draft guidance are being followed by some US centers, although the FDA draft is not final/approved. The Israeli colleagues ask if colleagues would please share what protocols are being used for re-entry of donors with reactive syphilis test results.

Please submit comments to the e-Network Forum.

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

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator