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Infectious Diseases

Poster Session 1

(333) A molecular diagnostic assay for syphilis infection among a high-risk pregnant cohort.

Tuesday, February 13, 2024
10:30 AM – 12:00 PM  
Location: Prince George's Exhibit Hall CDE, Lower Atrium Level

    Primary & Presenting Author(s)

  • Irene A. Stafford, MD, MS

    Associate Professor
    McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
    Houston, TX, United States

    • Coauthor(s)

  • MK

    Myra Kurjee, BS

    The University of Texas Health Science Center at Houston
    Houston, TX, United States

  • NG

    Nikita Ghosh, BS, MPH

    The University of Texas Health Science Center at Houston
    Houston, TX, United States

  • AD

    Ana Davie, MD

    The University of Texas Health Science Center at Houston
    Houston, TX, United States

  • JC

    Juan Camilo Padilla Ruiz, MD

    The University of Texas Health Science Center at Houston
    Houston, TX, United States

  • EM

    Erik Munson, PhD

    Assistant Professor
    Marquette University, WI, United States

Objective: Recommended syphilis screening during pregnancy relies on a serologic test to determine the host response towards antigenic components of the causative agent, Treponema pallidum. A novel research-use only transcription mediated amplification assay (TMA) targeting 16S rRNA of T. pallidum collected from mucosal tissue has demonstrated organism detection prior to seroconversion in rectal swabs collected from men. The aim of this pilot study is to determine detection rates of T. pallidum in provider or self-collected vaginal swab samples from pregnant women with syphilis.

Study Design: A prospective cohort study was conducted for all pregnant individuals who underwent routine syphilis screening via the recommended reverse or traditional screening methods between 01/23-06/23 at a high-risk obstetrical clinic. Vaginal swabs were collected by the provider or the patient at the same visit the syphilis screen was performed. All swabs were subjected to automated T. pallidum TMA (Hologic,Inc). Syphilis status was confirmed with the health department.

Results: Of 210 eligible patients, 191 (90%) underwent a provider collected or self-collected vaginal swab. Of those, 32 (16.7%) had detectable T. pallidum rRNA. Of these, 5 (15.6%) patients were positive for syphilis using the reverse algorithm with a reactive treponemal antibody and a confirmatory nontreponemal (NT) titer. The stage of syphilis varied, and NT titers ranged from 1:1-1:128. Nine (28.1%) with detectable T. pallidum RNA were screened by the traditional algorithm and yielded a nonreactive NT titer, and 8 (25%) were negative by the reverse algorithm (nonreactive treponemal antibody). The remaining 10 (31%) are pending testing for discordant results. None of the patients with nondetectable T. pallidum RNA tested positive using syphilis serology, yielding a 100% positive predictive value and 85% specificity.

Conclusion: The research-use only TMA test targeting 16S rRNA of T. pallidum demonstrated pathogen detection from vaginal mucosal specimens in pregnant individuals with syphilis. Further research is needed to determine its utility as a screening test.