Multiplex Assay for Simultaneous Detection of Mycoplasma genitalium and Macrolide Resistance Using PlexZyme and PlexPrime Technology

PLoS One. 2016 Jun 6;11(6):e0156740. doi: 10.1371/journal.pone.0156740. eCollection 2016.

Abstract

Mycoplasma genitalium is a cause of non-gonoccocal urethritis (NGU) in men and cervicitis and pelvic inflammatory disease in women. Recent international data also indicated that the first line treatment, 1 gram stat azithromycin therapy, for M. genitalium is becoming less effective, with the corresponding emergence of macrolide resistant strains. Increasing failure rates of azithromycin for M. genitalium has significant implications for the presumptive treatment of NGU and international clinical treatment guidelines. Assays able to predict macrolide resistance along with detection of M. genitalium will be useful to enable appropriate selection of antimicrobials to which the organism is susceptible and facilitate high levels of rapid cure. One such assay recently developed is the MG 23S assay, which employs novel PlexZyme™ and PlexPrime™ technology. It is a multiplex assay for detection of M. genitalium and 5 mutations associated with macrolide resistance. The assay was evaluated in 400 samples from 254 (186 males and 68 females) consecutively infected participants, undergoing tests of cure. Using the MG 23S assay, 83% (331/440) of samples were positive, with 56% of positives carrying a macrolide resistance mutation. Comparison of the MG 23S assay to a reference qPCR method for M. genitalium detection and high resolution melt analysis (HRMA) and sequencing for detection of macrolide resistance mutations, resulted in a sensitivity and specificity for M. genitalium detection and for macrolide resistance of 99.1/98.5% and 97.4/100%, respectively. The MG 23S assay provides a considerable advantage in clinical settings through combined diagnosis and detection of macrolide resistance.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Anti-Bacterial Agents / therapeutic use*
  • Bacterial Typing Techniques / methods
  • DNA Mutational Analysis / methods
  • Drug Resistance, Bacterial / genetics*
  • Female
  • Humans
  • Macrolides / therapeutic use*
  • Male
  • Microbial Sensitivity Tests / methods
  • Multiplex Polymerase Chain Reaction / methods*
  • Mycoplasma Infections / diagnosis*
  • Mycoplasma Infections / drug therapy
  • Mycoplasma Infections / microbiology
  • Mycoplasma genitalium* / drug effects
  • Mycoplasma genitalium* / genetics
  • Mycoplasma genitalium* / isolation & purification
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Urethritis / diagnosis
  • Urethritis / drug therapy
  • Urethritis / microbiology

Substances

  • Anti-Bacterial Agents
  • Macrolides

Grants and funding

In regards to the funding statement the authors would like to confirm that the funder (SpeedX) provided support in the form of salaries for authors (LT, SW, EM, AT). The funder did not have any role in the clinical evaluation including data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.