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Clinical Performance of Three Commercial Molecular Diagnostic Assays for the Detection of Fluoroquinolone Resistance-Associated Mutations in Mycoplasma genitalium

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The high prevalence of macrolide resistance in Mycoplasma genitalium results in an increased reliance on moxifloxacin, the second-line treatment; however, moxifloxacin resistance has also emerged. Because assays that can detect… Click to show full abstract

The high prevalence of macrolide resistance in Mycoplasma genitalium results in an increased reliance on moxifloxacin, the second-line treatment; however, moxifloxacin resistance has also emerged. Because assays that can detect fluoroquinolone resistance-associated mutations will be useful for the management of macrolide-resistant M. genitalium infections, we evaluated the performance of three commercial assays (the Allplex MG & MoxiR Assay [Seegene], LightMix Modular parC kit [TIBMOLBIOL], and MGMO qPCR [NYtor) in comparison with parC gene Sanger sequencing used as the reference. ABSTRACT The high prevalence of macrolide resistance in Mycoplasma genitalium results in an increased reliance on moxifloxacin, the second-line treatment; however, moxifloxacin resistance has also emerged. Because assays that can detect fluoroquinolone resistance-associated mutations will be useful for the management of macrolide-resistant M. genitalium infections, we evaluated the performance of three commercial assays (the Allplex MG & MoxiR Assay [Seegene], LightMix Modular parC kit [TIBMOLBIOL], and MGMO qPCR [NYtor) in comparison with parC gene Sanger sequencing used as the reference. Between January 2018 and December 2020, remnants of M. genitalium-positive clinical specimens received at the French National Reference Center for Bacterial Sexually Transmitted Infections were collected if a Sanger sequencing result was obtained for the parC gene. Overall, 368 M. genitalium-positive specimens were assessed. The clinical sensitivities for the detection of the ParC mutations that are likely of clinical significance were 91.8% (95% CI = 83.2 to 96.2), 98.6% (95% CI = 92.4 to 99.8), and 94.4% (95% CI = 86.6 to 97.8) for the Allplex MG & MoxiR, LightMix Modular parC, and MGMO qPCR kits, respectively, with no significant difference between the three kits. The clinical specificity of the Allplex MG & MoxiR and MGMO qPCR kits was 100% (95% CI = 97.7 to 100 and 98.7 to 100, respectively), which was significantly higher than the specificity of the LightMix Modular parC kit of 95.4% (95%CI = 92.3 to 97.3), for which the interpretation of melting curves may be misleading. These kits should be useful for the selection of antimicrobials in macrolide-resistant M. genitalium infections, although further developments may be necessary because parC mutations involved in fluoroquinolone resistance have not been precisely determined.

Keywords: associated mutations; resistance; mycoplasma genitalium; genitalium; fluoroquinolone resistance; resistance associated

Journal Title: Journal of Clinical Microbiology
Year Published: 2022

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