Evaluation of the Mycoplasma genitalium Resistance Plus kit for the detection of M. genitalium and mutations associated with macrolide resistance

Sexually Transmitted Infections
Rachel PittNeil Woodford

Abstract

To compare performance of the ResistancePlus kit (SpeeDx, Australia) with in-house methods for the detection of Mycoplasma genitalium-specific DNA and mutations associated with resistance to macrolide antimicrobials, directly from clinical specimens. Assay specificity and sensitivity was analysed using DNA from 46 non-M. genitalium organisms and standard curve analysis, respectively. A panel of archived DNA extracted from 97 M. genitalium-positive clinical specimens, for which the macrolide susceptibility genotype had been previously determined, were tested on the assay and results compared. Final analytical specificity was 100%. Sensitivity was detected to at least 140 genome copies/µL. The assay detected M. genitalium in 92/97 (94.9%, 95% CI 88.4% to 98.3%) previously positive specimens. The genetic macrolide susceptibility assigned was concordant with previous results in 85/92 (92.4%, 95% CI 85.0% to 96.9%) specimens or 85/97 (87.6%, 95% CI: 79.4% to 93.4%) when the false-negative specimens were included. On seven (7/92, 7.6%) occasions, resistant specimens were called susceptible. Further testing resolved discrepancies for all but five (5.2%) specimens. The ResistancePlus assay generally performed well in comparison to meth...Continue Reading

References

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Citations

Mar 19, 2019·Emerging Infectious Diseases·Tim R H ReadCatriona S Bradshaw
Feb 6, 2020·International Journal of STD & AIDS·David Taylor-RobinsonAnna Pallecaros
Dec 12, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Béatrice BerçotUNKNOWN ANRS IPERGAY Study Group

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