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

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 Full article

Journal

Sexually Transmitted Infections
ISSN: 1472-3263 , E-ISSN: 1368-4973

Output data

Year: 2022, Pages: sextrans-055249 Pages count : DOI: 10.1136/sextrans-2021-055249

Authors

Shipitsyna Elena ¹ , Khusnutdinova Tatiana ^1,2 , Budilovskaya Olga ^1,2 , Shedko Elizaveta ³ , Goloveshkina Elena ³ , Khayrullina Guzel ⁴ , Krysanova Anna ^1,2 , Shalepo Kira ^1,2 , Savicheva Alevtina ^1,2 , Unemo Magnus ⁵

Affiliations

1	Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, St. Petersburg, Russian Federation.
2	Department of Clinical Laboratory Diagnostics, St. Petersburg State Pediatric Medical University, St. Petersburg, Russian Federation
3	Laboratory of Molecular Diagnostics and Epidemiology of Reproductive Tract Infections, Central Research Institute of Epidemiology, Moscow, Russian Federation
4	Group of Development and Implementation of New Technologies and Products, Central Research Institute of Epidemiology, Moscow, Russian Federation
5	Department of Laboratory Medicine, Orebro universitet, SE-701 85 Orebro, Sweden

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% (ptrend=0.0009) and 10% (ptrend=0.0447), respectively, in 2018-2020. QRAM rate appeared to increase (from 0% to 13%), but significance was not reached (ptrend=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.

Shipitsyna E. , Khusnutdinova T. , Budilovskaya O. , Shedko E. , Goloveshkina E. , Khayrullina G. , Krysanova A. , Shalepo K. , Savicheva A. , Unemo M.
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
Sexually Transmitted Infections. 2022. P.sextrans-055249. DOI: 10.1136/sextrans-2021-055249 WOS Scopus РИНЦ OpenAlex

Published online:

May 1, 2020

Web of science:	WOS:000813067300001
Scopus:	2-s2.0-85132821296
Elibrary:	49150021
OpenAlex:	W4282970543

DB	Citing
OpenAlex	5
Web of science	4
Scopus	3