Performance of Three Commercial Molecular Diagnostic Assays for the Simultaneous Detection of Mycoplasma genitalium and Macrolide Resistance.

The increasing frequency of macrolide resistance is an emerging issue in the treatment of Mycoplasma genitalium infection. Because evaluation of new commercial kits detecting M. genitalium and macrolide resistance is needed, we evaluated the performance and handling characteristics of the Allplex MG & AziR (Seegene), the Macrolide-R/MG ELITe MGB (ELITechGroup), and the ResistancePlus MG FleXible (SpeeDx-Cepheid) kits in comparison with those of an in-house real-time PCR and 23S rRNA gene sequencing used as the reference. A total of 239 urogenital specimens (135 M. genitalium-positive and 104 M. genitalium-negative specimens) collected between April and December 2019 at the French National Reference Center for Bacterial Sexually Transmitted Infections were assessed. The overall agreement for M. genitalium detection of the three commercial kits compared with the in-house real-time PCR was 94.6 to 97.6%, and there was no significant difference. A total of 97 specimens were found to be M. genitalium positive with the three kits and were used to assess macrolide resistance detection. The clinical sensitivities for resistance detection were 74.5% (95% confidence interval, 61.7 to 84.2%), 96.2% (87.2 to 99.0%), and 92.8% (82.7 to 97.1%) for the Allplex MG & AziR, Macrolide-R/MG ELITe MGB, and ResistancePlus MG FleXible kits, respectively. The sensitivity of the Macrolide-R/MG ELITe MGB kit was significantly higher than that of the Allplex MG & AziR kit. The clinical specificity for resistance detection of the three kits was 97.4 to 97.6%. The random-access possibility, input sample volume, and DNA extract availability for detecting resistance to other antibiotics may also influence the selection of a commercial kit by diagnostic laboratories.