Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
[Preprint]. 2025 Nov 9:2025.11.07.25339586.
doi: 10.1101/2025.11.07.25339586.

Estimating the sensitivity of non-treponemal and treponemal antibody tests in primary syphilis

Stephanie F Sweitzer  1 , Jane S Chen  1 , Mitch M Matoga  2 , Ligang Yang  3 , Eduardo Lopez-Medina  4   5 , Jonny A Garcia-Luna  4   6 , Irving F Hoffman  1 , Bin Yang  3 , Juan C Salazar  4   7   8 , Justin D Radolf  7   8 , Jonathan B Parr  1 , Arlene C Seña  1
Affiliations

Estimating the sensitivity of non-treponemal and treponemal antibody tests in primary syphilis

Stephanie F Sweitzer et al. medRxiv. .

Abstract

Among patients with primary syphilis, sensitivity of TRUST was 55% (6/11) compared to darkfield microscopy (DFM) and 60% (9/15) compared to Treponema pallidum PCR. Sensitivity of RPR was 78% (38/49) and 93% (43/46), respectively. TPPA had a sensitivity of 95% (41/43) compared to DFM and 96% (43/45) compared to PCR.

Keywords: Syphilis; diagnostics; non-treponemal testing.

PubMed Disclaimer

Conflict of interest statement

ACS reports royalties from UptoDate; past honoraria from Innoviva Specialty Therapeutics and Hologic, Inc, for their scientific advisory board and conference travel, respectively; and support for meetings or travel from the American Sexually Transmitted Diseases Association as a member of the Executive Board outside the scope of the current work. JAG-L reports honoraria from the Universidad de Antioquia; support for meetings or travel from Carnott Laboratories, Cantabria Labs, Epidermique, Pharmaderm, and Janssen; receipt of writing materials from Epidermique, Cantabria labs, Isdin, Pharmaderm, Skindrugs, Loreal, Galderma, Cetaphil, Cerave, Isispharma, Carnott, Janssen, Pharmalab, Novartis, Pfizer, and Lilly outside of the scope of work. JDR receives royalties from Biokit, Chembio, and Span Diagnostics for syphilis serodiagnostic reagents. JBP reports non-financial support from Abbott Diagnostics and past research support from Gilead Sciences, all outside the scope of the current work. This project was funded in part by the National Institute for Allergy and Infectious Diseases (NIAID; U19AI144177 to JDR and MAM). This work also was supported, in part, by the Bill & Melinda Gates Foundation (INV-036560 to ACS) and strategic research dollars from Connecticut Children’s. SFS is supported by NIH NIAID grant #T32-AI007001.

References

    1. Theel ES, Katz SS, Pillay A. Molecular and direct detection tests for Treponema pallidum subspecies pallidum: a review of the literature, 1964–2017. Clin Infect Dis Off Publ Infect Dis Soc Am. 2020;71(Suppl 1):S4–S12. doi: 10.1093/cid/ciaa176 - DOI
    1. Flipse J, Niekamp AM, Dirks A, et al. Refining timely diagnosis of early syphilis by using Treponema pallidum PCR or IgM immunoblotting next to conventional serology for syphilis. J Clin Microbiol. 61(6):e00112–23. doi: 10.1128/jcm.00112-23 - DOI
    1. Gayet-Ageron A, Lautenschlager S, Ninet B, Perneger TV, Combescure C. Sensitivity, specificity and likelihood ratios of PCR in the diagnosis of syphilis: a systematic review and meta-analysis. Sex Transm Infect. 2013;89(3):251–256. doi: 10.1136/sextrans-2012-050622 - DOI - PubMed
    1. Satyaputra F, Hendry S, Braddick M, Sivabalan P, Norton R. The laboratory diagnosis of syphilis. J Clin Microbiol. 2021;59(10):e00100–21. doi: 10.1128/JCM.00100-21 - DOI - PMC - PubMed
    1. Papp JR, Park IU, Fakile Y, Pereira L, Pillay A, Bolan GA. CDC laboratory recommendations for syphilis testing, United States, 2024. MMWR Recomm Rep Morb Mortal Wkly Rep Recomm Rep. 2024;73(1):1–32. doi: 10.15585/mmwr.rr7301a1 - DOI

Publication types

LinkOut - more resources