Bulletin 15-18

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Clarification Regarding Confirmatory Tests for Syphilis

Bulletin 15-18

December 8, 2015

In mid September, the Food and Drug Administration (FDA) issued Final Guidance for Industry titled "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)". In early October, the AATB provided clarification regarding which tests could be used for tissue donor screening (see Bulletin #15-13, Important Information Regarding FDA Final Guidance Issued for Syphilis Testing).

Another clarification can be reported. The AATB recently asked an official of the Division of Human Tissue at FDA which tests can be used for confirmatory testing when a non-treponemal screening test was used and is reactive. Their response contained the following information:

"Per 21 CFR Part 1271.80(d)(1), a donor that tests positive on a donor screening assay is considered ineligible, with exception of "a donor whose specimen tests reactive on a non-treponemal screening test for syphilis and negative on a specific treponemal confirmatory test". Therefore, use of any legally marketed treponemal-specific test kits, including those that do not have specific "confirmatory" labeling, would be consistent with 21 CFR Part 1271.80(d)(1)."

Additionally, it was reported that the FDA website previously listed an FTA-ABS assay as an example of an acceptable confirmatory test for syphilis and, although it was noted to be only a partial list, there was potential for misinterpretation so the partial list was removed from the website.

The package insert for the only FDA-cleared non-treponemal test for screening tissue donors for syphilis (find it here) does not specifically identify which treponemal-specific test must be used as a confirmatory test when the RPR result is reactive.

Contact Scott Brubaker if you have any questions.