Analytical Performance Characteristics of a New Transcription-Mediated Amplification Assay for Treponema pallidum.

ABSTRACT: This study evaluated the performance characteristics of a new research-use-only transcription-mediated amplification (TMA) assay for the detection of rRNA from Treponema pallidum. Analytical sensitivity determined using dark-field microscopy-quantitated T. pallidum was 1.4 organisms/ml (95% confidence interval [CI], 0.7 to 6.33 organisms/ml). Dilution of in vitro-transcribed (IVT) T. pallidum RNA in Aptima sample transport medium (STM) yielded 100% positivity (n = 3) at 10 copies/ml (4 copies/reaction). Analytical specificity testing of nontarget microorganisms (n = 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

SUBMITTER: Getman D 

PROVIDER: S-EPMC8373238 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature