First FDA-Cleared Mycoplasma genitalium NAAT Validated in 3,361-Subject US Multicenter Study
The AMES study validated the Aptima Mycoplasma genitalium TMA assay across 21 US sites using 11,556 urogenital specimens from 3,361 subjects, establishing it as the first FDA-cleared NAAT for this pathogen. Sensitivity ranged from 77.8% to 98.9% depending on specimen type, with specificities consistently above 97.8%. M. genitalium prevalence was approximately 10% in both sexes, with notably high rates in asymptomatic subjects, underscoring the public health value of validated molecular detection.
The original study
Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study.
- Authors
- Gaydos CA, Manhart LE, Taylor SN, Lillis RA, Hook EW, Klausner JD, et al.
- Journal
- Journal of clinical microbiology
- Type
- Clinical Study, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
- PMID
- 31484702
Original 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.