Treponema pallidum Nucleic Acid Amplification Testing To Augment Syphilis Screening among Men Who Have Sex with Men.

Syphilis rates in much of the world are now at their highest levels in almost three decades, and new approaches to controlling syphilis, including diagnostic tests with shorter window periods, are urgently needed. We compared the sensitivity of syphilis serological testing using the rapid plasma reagin (RPR) test with that of the combination of serological testing and an experimental 23S rRNA Treponema pallidum real-time transcription-mediated amplification (TMA) assay performed on rectal and pharyngeal mucosal swabs. T. pallidum PCR assays for the tpp47 gene were performed on all TMA-positive specimens, as well as specimens from 20 randomly selected TMA-negative men. A total of 545 men who have sex with men (MSM) who were seen in a sexually transmitted disease clinic provided 506 pharyngeal specimens and 410 rectal specimens with valid TMA results. Twenty-two men (4%) were diagnosed with syphilis on the basis of positive RPR test results and clinical diagnoses, including 3 men with primary infections, 8 with secondary syphilis, 9 with early latent syphilis, 1 with late latent syphilis, and 1 with an unstaged infection. Two additional men were diagnosed based on positive rectal mucosal TMA assay results alone, and both also tested positive by PCR assay. At least 1 specimen was TMA positive for 12 of 24 men with syphilis (sensitivity, 50% [95% confidence interval [CI], 29 to 71%]). RPR testing and clinical diagnosis were 92% sensitive (95% CI, 73 to 99%) in identifying infected men. Combining mucosal TMA testing and serological testing may increase the sensitivity of syphilis screening in high-risk populations.