Bacteriology

Evaluation of the ResistancePlus MG FleXible Assay for Detection of Wild-Type and 23S rRNA-Mutated Mycoplasma genitalium Strains

Suhella Tulsiani Drud, Peter Njuguna, Samantha Ebeyan, Simon Erskine, Mette Holm, Susanne Cramer Johansson, Lit Yeen Tan, Jorgen Skov Jensen
Erik Munson, Editor
DOI: 10.1128/JCM.01900-19

Article Figures & Data

Tables

  • TABLE 1

    M. genitalium strains tested as part of inclusivitya

    TABLE 1

    • ↵a All strains were tested at 2 × LOD.

  • TABLE 2

    Phylogenetically related and nontarget organisms tested for analytical specificitya,b

    TABLE 2

    • ↵a All organisms were tested at 1 × 106 genomes/ml except where indicated.

    • ↵b ND, M. genitalium not detected; 23S rRNA mutation not detected.

    • ↵c Tested at 1 × 105 genomes/ml.

    • ↵d Quantified as PFU/ml.

    • ↵e Quantified as CFU/ml.

  • TABLE 3

    Substances tested to assess interference in the performance of the ResistancePlus MG FleXible assay

    TABLE 3

    • ↵a D, output result “M. genitalium detected; 23S rRNA mutation detected”; ND, output result “M. genitalium not detected; 23S rRNA mutation not detected.”

    • ↵b Interference may be observed in samples containing >0.4% whole blood.

    • ↵c Interference may be observed in samples containing >0.18 mg/ml bilirubin.

    • ↵d Interference may be observed in samples containing >0.1% wt/vol Vagisil intimate powder.

    • ↵e NA, not applicable.

  • TABLE 4

    Analytical sensitivity of the ResistancePlus MG Flexible assay for detection of M. genitalium and 23S rRNA mutation types and comparison with the MgPa assay for the detection of M. genitalium

    TABLE 4
  • TABLE 5

    Clinical sensitivity and specificity of the ResistancePlus MG FleXible assay (RPMG Flex)a

    TABLE 5

    • ↵a NA, not applicable.

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KEYWORDS

Mycoplasma genitalium
detection
macrolide resistance
GeneXpert Dx
ResistancePlus MG FleXible
diagnostics
molecular assay
near-patient

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