Analytical Performance Characteristics of a New Transcription-Mediated Amplification Assay for Treponema pallidum
Damon Getman, Mike Lin, Nesreen Barakat, Rhonda Skvoretz, Charmie Godornes, Paul D. Swenson, Ashley Nenninger, Matthew R. Golden, Sheila A. Lukehart
Abstract
= 59), including the closely related nonsyphilis treponemes Treponema denticola and Treponema phagedenis, yielded 0% positivity. TMA testing of mucosal swab specimens collected from men who have sex with men (MSM) attending a sexually transmitted disease clinic yielded 1.8% (17/944) positive results. A collection of 56 serum specimens obtained from a separate cohort of patients with known rapid plasma reagin (RPR) statuses and clinical diagnoses of syphilis was 19.6% (11/56) TMA positive overall and 29.7% (11/37) positive among subjects with syphilis diagnoses, including 8 (36.3%) of 22 persons with primary or secondary syphilis, 2 (20%) of 10 persons with early latent syphilis, and 1 (20%) of 5 persons with late latent or unstaged syphilis. None (0%) of the 18 RPR-positive sera from patients with histories of treated syphilis were TMA positive. These results show that TMA is an analytically sensitive and specific method for the detection of T. pallidum rRNA and is compatible with serum specimens in addition to pharyngeal and rectal mucocutaneous swab specimens. Automated real-time TMA testing for T. pallidum may be useful as an adjunctive method with serology for screening and diagnostic testing of selected patient populations for syphilis.