Characteristics of Mycoplasma genitalium Urogenital Infections in a Diverse Patient Sample from the United States: Results from the Aptima Mycoplasma genitalium Evaluation Study (AMES).

Data from a large prospective multicenter clinical validation study of a nucleic acid amplification diagnostic test for were analyzed to describe the prevalence of infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. Among 1,737 female and 1,563 male participants, the overall prevalence of infection was 10.3% and was significantly higher in persons ages 15 to 24 years than in persons ages 35 to 39 years (for females, 19.

Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Vaginitis Assays: Results from a Prospective Multicenter Clinical Study.

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima vaginitis (CV/TV) assays.

Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study.

A prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new diagnostic nucleic acid amplification test (NAAT) for the detection of Seven urogenital specimen types ( = 11,556) obtained from 1,778 females, aged 15 to 74 years, and 1,583 males, aged 16 to 82 years, were tested with the Aptima assay, an investigational transcription-mediated amplification (TMA) NAAT for the detection of 16S rRNA. Infected status for enrolled subjects was established using results obtained from testing either self-collected vaginal swab or clinician-collected male urethral swab specimens with a composite reference method consisting of three transcription-mediated amplification NAATs targeting unique regions of 16S or 23S rRNA. prevalence was 10.

Design and Validation of Transcription-Mediated-Amplification Nucleic Acid Amplification Tests for Mycoplasma genitalium.

is a sexually transmitted bacterium linked to adverse sexual and reproductive health outcomes in women and men. is difficult to culture, and in the absence of validated amplified molecular methods for diagnosis of infection, there is no reference standard available for use as a comparator for the validation of new diagnostic tests. We evaluated the analytical and clinical performance of three transcription-mediated amplification (TMA) tests for , each targeting unique rRNA sequences, for use as a composite comparator for clinical validation of the Aptima (AMG) assay, an diagnostic (IVD) TMA test that targets 16 s rRNA of Analytical sensitivity, specificity, and strain inclusivity of all four TMA tests were determined using nine laboratory strains of and 56 nontarget bacteria, protozoa, and viruses.

Mycoplasma genitalium infection in women attending a sexually transmitted infection clinic: diagnostic specimen type, coinfections, and predictors.

In female sexually transmitted infection clinic attendees, Mycoplasma genitalium was more frequently detected using vaginal (53/73) versus endocervical (43/73) specimens. In women without other sexually transmitted infections, M. genitalium detection (N = 44) was associated with age ≤22 years (odds ratio, 2.

Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial.

Trichomoniasis is a common sexually transmitted disease associated with preterm birth, low birth weight, and increased susceptibility to infection with other pathogenic sexually transmitted microorganisms. Nucleic acid amplification tests for Trichomonas vaginalis have improved sensitivity for detecting infected individuals compared to existing culture-based methods. This prospective, multicenter U.