TY - JOUR T1 - Performance of the first commercial dual resistance assay, AmpliSens <em>Mycoplasma genitalium</em>-ML/FQ-Resist-FL, for detection of potential macrolide and quinolone resistance-associated mutations and prevalence of <em>M. genitalium</em> resistance mutations in St. Petersburg, Russia JF - Sexually Transmitted Infections JO - Sex Transm Infect DO - 10.1136/sextrans-2021-055249 SP - sextrans-2021-055249 AU - Elena Shipitsyna AU - Tatiana Khusnutdinova AU - Olga Budilovskaya AU - Elizaveta Shedko AU - Elena Goloveshkina AU - Guzel Khayrullina AU - Anna Krysanova AU - Kira Shalepo AU - Alevtina Savicheva AU - Magnus Unemo Y1 - 2022/06/15 UR - http://sti.bmj.com/content/early/2022/06/15/sextrans-2021-055249.abstract N2 - 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. ER -