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Updated: Apr 26, 2026

Author Spotlight: Advancing Syphilis Research — Innovations in Treponema pallidum Cultivation and Genetic Engineering
Published on: January 24, 2025
Current trends in donor testing to detect syphilis infection.
Karoll J Cortez1, Melissa A Greenwald
1Human Tissue and Reproduction Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hamsphire Ave. Bldg. 71, Silver Spring, MD, 20993-0002, USA, karoll.cortez@fda.hhs.gov.
Syphilis testing in organ and tissue donors is crucial. Understanding treponemal and nontreponemal serologic assays aids in selecting appropriate tests to ensure donor safety and prevent infection transmission.
Area of Science:
- Infectious Diseases
- Clinical Diagnostics
- Transplantation Immunology
Background:
- Organ and tissue donation requires rigorous screening for infectious agents.
- Treponema pallidum (T. pallidum) is the bacterium causing syphilis, a significant concern in donor populations.
- Accurate syphilis detection is vital to prevent transmission during transplantation.
Purpose of the Study:
- To review syphilis testing strategies for organ and tissue donors.
- To discuss factors influencing the selection and interpretation of syphilis assays.
- To highlight the principles of available serologic tests for donor screening.
Main Methods:
- Review of serologic assay principles for syphilis detection.
- Analysis of treponemal and nontreponemal assay characteristics.
- Discussion of syphilis testing algorithms in donor settings.
Main Results:
- Serologic assays are the primary method for syphilis screening in donors.
- Both treponemal and nontreponemal assays have distinct advantages and limitations for donor testing.
- Clinical diagnostic syphilis testing algorithms provide a framework for donor assay selection.
Conclusions:
- Appropriate selection of syphilis assays is critical for organ and tissue donor safety.
- Understanding assay principles and limitations improves the interpretation of results.
- Effective donor screening protocols minimize the risk of syphilis transmission through transplantation.
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