TABLE 2

Evaluation of the ResistancePlus MG assay for the detection of M. genitalium and 23S rRNA gene mutationsa

ParameterResistancePlus MG resultReference assay result (no. of specimens)b% sensitivity (95% CI)/% specificity (95% CI) (negative predictive value [95% CI]/positive predictive value [95% CI])
PosNegTotal
M. genitaliumPos6406498.5 (91.7–99.9)/100 (99.6–100) (99.9 [99.5–100]/100 [94.4–100])
Neg1c1,0241,025
23S rRNA mutationDetected38139100 (90.8–100)/96.2 (80.4–99.9) (100 [86.3–100]/97.4 [86.5–99.9])
Not detected02525
  • a Pos, positive; Neg, negative.

  • b The reference assay used for M. genitalium detection was a standard assay in use in the laboratory (22, 23), and the assays used for 23S rRNA mutation status detection were Sanger sequencing and HRMA (14, 16). In the comparison of mutation detection results, Pos by the reference assay represents detection of a mutant strain and Neg represents detection of the wild-type strain.

  • c Fewer than 100 copies of M. genitalium were detected in the sample.