Clinical evaluation of the ResistancePlus MG FleXible test on the GeneXpert Infinity-48s instrument: a near-patient assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance.

Miguel Fernández-Huerta, Paula Salmerón, Aroa Silgado, Mateu Espasa, Tomàs Pumarola, Suhella Tulsiani-Drud, María-Jesús Barberá, Yannick Hoyos-Mallecot, Judit Serra-Pladevall

Diagnostic microbiology and infectious disease 2020 Aug

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Antibiotic resistance in Mycoplasma genitalium (MG) is rising globally, especially to macrolides. In response to this challenge, assays reporting both the detection of MG and macrolide resistance-mediating mutations (MRMM) allow therapy to be tailored to the individual. The study evaluated the performance of the ResistancePlus® MG FleXible assay for the detection of MG and MRMM. Overall, the test performed well for the detection of MG compared to the AllplexTM STI Essential assay, used as a reference, with a kappa value of 0.926 (95% CI, 0.863-0.990). The kit also performed well for the detection of MRMM when compared with Sanger sequencing of the 23S rRNA gene, with a kappa value of 0.901 (95% CI, 0.807-0.996). The rate of MRMM in MG among the study population was 41.8%. In conclusion, the ResistancePlus® MG FleXible is a rapid, simple, and accurate cartridge-based assay for simultaneous detection of MG and MRMM in clinical settings. Copyright © 2020 Elsevier Inc. All rights reserved.

Citation

Miguel Fernández-Huerta, Paula Salmerón, Aroa Silgado, Mateu Espasa, Tomàs Pumarola, Suhella Tulsiani-Drud, María-Jesús Barberá, Yannick Hoyos-Mallecot, Judit Serra-Pladevall. Clinical evaluation of the ResistancePlus MG FleXible test on the GeneXpert Infinity-48s instrument: a near-patient assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance. Diagnostic microbiology and infectious disease. 2020 Aug;97(4):115062