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

J Clin Microbiol. 2019 Oct 23;57(11):e01125-19. doi: 10.1128/JCM.01125-19. Print 2019 Nov.

Abstract

A prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new in vitro diagnostic nucleic acid amplification test (NAAT) for the detection of Mycoplasma genitalium Seven urogenital specimen types (n = 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 Mycoplasma genitalium assay, an investigational transcription-mediated amplification (TMA) NAAT for the detection of M. genitalium 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 M. genitalium 16S or 23S rRNA. M. genitalium prevalence was 10.2% in females and 10.6% in males; prevalence was high in both symptomatic and asymptomatic subjects for both sexes. Compared to the subject infected status standard, the investigational test had sensitivity and specificity estimates, respectively, of 98.9% and 98.5% for subject-collected vaginal swabs, 92.0% and 98.0% for clinician-collected vaginal swabs, 81.5% and 98.3% for endocervical swabs, 77.8% and 99.0% for female urine, and 98.2% and 99.6% for male urethral swabs, 88.4% and 97.8% for self-collected penile meatal swabs, and 90.9% and 99.4% for male urine specimens. For all seven specimen types, within-specimen positive and negative agreements between the investigational test and the composite reference standard ranged from 94.2% to 98.3% and from 98.5 to 99.9%, respectively. These results provide clinical efficacy evidence for the first FDA-cleared NAAT for M. genitalium detection in the United States.

Keywords: Aptima; Aptima Mycoplasma genitalium Evaluation Study (AMES); Mycoplasma genitalium; sexually transmitted infection.

Publication types

  • Clinical Study
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cross-Sectional Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / methods
  • Molecular Diagnostic Techniques / standards*
  • Mycoplasma Infections / diagnosis*
  • Mycoplasma Infections / epidemiology
  • Mycoplasma Infections / microbiology*
  • Mycoplasma Infections / urine
  • Mycoplasma genitalium
  • Nucleic Acid Amplification Techniques / methods
  • Nucleic Acid Amplification Techniques / standards*
  • Prevalence
  • Prospective Studies
  • RNA, Ribosomal, 16S / genetics
  • RNA, Ribosomal, 23S / genetics
  • Sensitivity and Specificity
  • Sexually Transmitted Diseases / diagnosis
  • Sexually Transmitted Diseases / microbiology
  • United States / epidemiology
  • Urethra / microbiology
  • Vagina / microbiology
  • Young Adult

Substances

  • RNA, Ribosomal, 16S
  • RNA, Ribosomal, 23S