Vaginitis and risk of sexually transmitted infections: results of a multi-center U.S. clinical study using STI nucleic acid amplification testing.

Unlabelled: Significant increases in rates of sexually transmitted infections (STIs) caused by (TV), (CT), (NG), and (MG) are occurring in the United States. We present results of a U.S.

Timely Diagnosis of Incubating Syphilis Infections Using Treponema pallidum Transcription-Mediated Amplification Assay.

Background: Syphilis is a complex, multistage, sexually transmitted infection (STI) caused by the bacterium Treponema pallidum subspecies pallidum (TP). New diagnostic tools are needed to minimize transmission. In this study, we aimed to assess the additional value of an investigational transcription-mediated amplification test for TP (TP-TMA) for routine diagnostics.

Mycoplasma genitalium in the US (MyGeniUS): Surveillance Data From Sexual Health Clinics in 4 US Regions.

Background: Mycoplasma genitalium (MG) is on the CDC Watch List of Antimicrobial Resistance Threats, yet there is no systematic surveillance to monitor change.

Methods: We initiated surveillance in sexual health clinics in 6 cities, selecting a quota sample of urogenital specimens tested for gonorrhea and/or chlamydia. We abstracted patient data from medical records and detected MG and macrolide-resistance mutations (MRMs) by nucleic acid amplification testing.

Distribution of Macrolide Resistant Mycoplasma genitalium in Urogenital Tract Specimens From Women Enrolled in a US Clinical Study Cohort.

Background: This study evaluated the distribution of macrolide-resistant Mycoplasma genitalium in multiple urogenital specimens collected from women enrolled in a prospective multicenter US clinical study.

Methods: Four female urogenital specimens (vaginal swab, urine, endocervical swab, ectocervical brush/spatula) collected from each subject were tested using a transcription-mediated amplification (TMA) assay for M. genitalium.

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

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.