TABLE 6

Clinical sensitivity, specificity, and predictive values of the Aptima Mycoplasma genitalium assay for detection of M. genitalium in urogenital specimens

CategoryNo. of specimens or % agreement (95% CI) for Alt TMA composite comparatora
+Total
AMG IVD detection result
    +85186
    −01,3141,314
Total851,3151,400
Sensitivity100 (95.7–100)
Specificity99.9 (99.6–99.9)
Positive predictive value98.8 (93.7–99.8)
Negative predictive value100 (99.7–100)
  • a Consensus result of Alt TMA-1 and -2 assays, with Alt TMA-3 result used for discordant resolution.