TABLE 1

Analytical sensitivity (95% limit of detection) of transcription-mediated amplification assays for detection of M. genitalium nucleic acids: M. genitalium strain M30 in four clinical specimen matrixes, and in vitro RNA transcript in STM

Analyte and specimen matrixValue (95% CI) for:
AMG IVDAlt TMA-1Alt TMA-2Alt TMA-3
M. genitalium strain M30 (GE/ml)
    Vaginal swab0.040 (0.026–0.119)0.035 (0.023–0.072)0.017 (0.011–0.038)0.029 (0.019–0.064)
    Female urine0.035 (0.021–0.091)0.017 (0.011–0.031)0.019 (0.013–0.035)0.024 (0.016–0.047)
    Male urine0.028 (0.017–0.074)0.027 (0.016–0.063)0.030 (0.019–0.070)0.025 (0.016–0.054)
    Penile meatal swab0.026 (0.017–0.060)0.034 (0.022–0.074)0.020 (0.013–0.041)0.026 (0.017–0.058)
rRNA (copies/ml)a
    STM16.5 (10.2–40.9)61.9 (33.7–177)23.5 (14.5–55.9)20.9 (12.3–55.8)
  • a In vitro transcribed RNA corresponding to M. genitalium strain M30 16S rRNA (AMG IVD, Alt TMA-1) or 23S rRNA (Alt TMA-2, Alt TMA-3).