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Comparative Analysis of Molecular and Serologic Testing for Primary Syphilis: A Population-Based Cohort Study
Caley Bryce Shukalek1,2,3,4, Bonita Lee3,5, Sumana Fathima6
1Department of Medicine, University of Calgary, Calgary, AB, Canada.
Frontiers in Cellular and Infection Microbiology
|May 10, 2021
Summary
Rapid PCR testing accurately identifies infectious syphilis lesions, improving diagnosis and treatment. This molecular diagnostic offers a reliable yes-no answer for primary syphilis, aiding epidemic control.
Area of Science:
- Infectious Diseases
- Microbiology
- Molecular Diagnostics
Background:
- Rising rates of syphilis (T. pallidum) necessitate improved diagnostic methods.
- Current syphilis serology is complex and requires interpretation.
- Molecular diagnostics offer potential for direct pathogen identification.
Purpose of the Study:
- To evaluate the accuracy of T. pallidum Polymerase Chain Reaction (Tp-PCR) compared to serology for diagnosing primary syphilis in adults with anogenital lesions.
- To assess the performance characteristics of Tp-PCR in a large, real-world clinical setting.
Main Methods:
- Retrospective analysis of 3,600 adult patients with anogenital lesions at STI clinics in Alberta, Canada.
- Syphilis screening using both Tp-PCR and serological tests (INNO-LIA, RPR).
- Evaluation of Tp-PCR sensitivity, specificity, and predictive values against serological diagnosis.
Main Results:
- 114 patients (3.1%) tested positive for T. pallidum by PCR (Tp-PCR+).
- Tp-PCR demonstrated high specificity (99.9%) and a positive predictive value of 97.4%.
- 12 Tp-PCR+ samples were initially serology-negative but became positive within 28 days, highlighting early detection potential.
Conclusions:
- T. pallidum PCR is an accurate assay for the rapid identification of primary syphilis.
- Tp-PCR can aid in timely treatment and prevention of syphilis spread.
- Molecular diagnostics represent a valuable tool in managing the growing syphilis epidemic.
