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  • Performance of the first commercial dual resistance assay, AmpliSens Mycoplasma genitalium-ML/FQ-Resist-FL, for detection of potential macrolide and quinolone resistance-associated mutations and prevalence of M. genitalium resistance mutations in St. Pet…

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Performance of the first commercial dual resistance assay, AmpliSens Mycoplasma genitalium-ML/FQ-Resist-FL, for detection of potential macrolide and quinolone resistance-associated mutations and prevalence of M. genitalium resistance mutations in St. Petersburg, Russia
  1. Elena Shipitsyna1,
  2. Tatiana Khusnutdinova1,2,
  3. Olga Budilovskaya1,2,
  4. Elizaveta Shedko3,
  5. Elena Goloveshkina3,
  6. Guzel Khayrullina4,
  7. Anna Krysanova1,2,
  8. Kira Shalepo1,2,
  9. Alevtina Savicheva1,2,
  10. Magnus Unemo5,6
  1. 1 Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, St. Petersburg, Russian Federation
  2. 2 Department of Clinical Laboratory Diagnostics, St. Petersburg State Pediatric Medical University, St. Petersburg, Russian Federation
  3. 3 Laboratory of Molecular Diagnostics and Epidemiology of Reproductive Tract Infections, Central Research Institute of Epidemiology, Moscow, Russian Federation
  4. 4 Group of Development and Implementation of New Technologies and Products, Central Research Institute of Epidemiology, Moscow, Russian Federation
  5. 5 WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Orebro universitet, Orebro, Sweden
  6. 6 Institute for Global Health, University College London, London, UK
  1. Correspondence to Dr Magnus Unemo, Department of Laboratory Medicine, Orebro universitet, SE-701 85 Orebro, Sweden; magnus.unemo{at}orebroll.se

Abstract

Objectives Antimicrobial resistance in Mycoplasma genitalium (MG) is a poorly surveyed and controlled global health concern. We evaluated the first commercial dual resistance assay, AmpliSens M. genitalium-ML/FQ-Resist-FL assay, for detection of potential macrolide and quinolone resistance-associated mutations (MRAMs and QRAMs, respectively) and estimated the prevalence of these mutations in MG in St. Petersburg, Russia.

Methods Urogenital samples positive (n=145 from 2007 to 2020) and negative (n=56 from 2021) for MG in routine diagnostics were retrospectively analysed using the AmpliSens M. genitalium-ML/FQ-Resist-FL assay (Central Research Institute of Epidemiology, Moscow, Russia) and Sanger sequencing for validation.

Results The AmpliSens M. genitalium-ML/FQ-Resist-FL assay detected potential MRAMs and QRAMs with sensitivities of 100% (CI95% 83.9 to 100) and 92.3% (CI95% 66.7 to 99.6) and specificities of 99.2% (CI95% 95.6 to 100) and 100% (CI95% 97.2 to 100), respectively, in clinical specimens with ≥1000 MG geq/mL. In total, MRAMs were detected in 13.8% (CI95% 9.1 to 20.3) of samples, with 23S rRNA A2058G being the most prevalent mutation (45.0% (CI95% 25.8 to 65.8)). QRAMs were found in 9.0% (CI95% 5.3 to 14.7) of samples, with S83I the most frequent mutation (53.8% (CI95% 29.1 to 76.8)). Dual resistance was observed in 5.5% (CI95% 2.8 to 10.5) of samples. Potential MRAM and dual resistance rates significantly increased over time: from 0% in 2007–2008 to 25% (p trend =0.0009) and 10% (p trend =0.0447), respectively, in 2018–2020. QRAM rate appeared to increase (from 0% to 13%), but significance was not reached (p trend =0.0605).

Conclusions The rapid increase in MG antimicrobial resistance in St. Petersburg, especially prominent for MRAMs, necessitates implementation of macrolide resistance-guided therapy in Russia. The first commercial dual resistance assay, AmpliSens M. genitalium-ML/FQ-Resist-FL assay, was sensitive and specific for detection of potential MRAMs and QRAMs and could be valuable in macrolide resistance-guided therapies and possibly for surveillance of QRAMs. International surveillance of antimicrobial resistance-associated mutations in MG, further research into clinical relevance of several parC mutations and novel treatments are essential.

  • Mycoplasma genitalium
  • URETHRITIS
  • Molecular Diagnostic Techniques
  • Drug Resistance, Bacterial
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/sextrans-2021-055249

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    Footnotes

    • Handling editor Francesca Ceccherini-Silberstein

    • Contributors EShi and MU conceived the study. EShi, TK, OB, EShe, EG, GK, AK, KS and AS were involved in collecting and testing samples. EShi with support of MU wrote a first draft of the manuscript. All authors participated in the analysis and interpretation of the data and provided critical revisions to the manuscript. All authors gave their final approval of the version to be published.

    • Funding The study was supported by the Ministry of Science and Higher Education of the Russian Federation (contract no. AAAA-A19-119-021290030-0). The Central Research Institute of Epidemiology provided the AmpliSens M. genitalium-ML/FQ-Resist-FL assay.

    • Disclaimer The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

    • Competing interests EShe, EG and GK are employees of the Central Research Institute of Epidemiology. The other authors declare that they have no competing interests.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.