5 years ago

French prospective clinical evaluation of the Aptima® Mycoplasma genitalium assay (CE-IVD) and macrolide resistance detection using three distinct assays.

Hénin N, Pereyre S, Le Roy C, Bébéar C
The aim of this study was to evaluate the clinical performance of the Aptima® Mycoplasma genitalium CE-IVD (MG-TMA) assay for the detection of Mycoplasma genitalium in clinical male and female samples in comparison with the in-house real-time PCR (in-house PCR) assay routinely used in our laboratory. A total of 1,431 clinical specimens obtained from 1,235 patients were prospectively collected at the Bacteriology Department of Bordeaux University Hospital (France). Additional research-use-only Aptima® M. genitalium TMA assays, Alt1-TMA and Alt2-TMA, were performed on discordant specimens to determine the M. genitalium infection status. All confirmed M. genitalium-positive specimens were tested for macrolide resistance using three assays: the in-house 23S FRET PCR assay, the SpeeDx ResistancePlus™ MG assay and the nested reverse-transcription (RT) PCR sequencing assay. The comparison of the MG-TMA assay with the in-house PCR results showed a moderate correlation (kappa value 0.69). The MG-TMA assay had higher clinical sensitivity compared to that of the in-house PCR assay (100% versus 59.74%, respectively) and similar specificity (99.10% versus 100%, respectively) for M. genitalium detection. In this study, the prevalence of M. genitalium infection was 5.90% (72/1,220 patients). The nested RT-PCR sequencing assay was the most sensitive but the most laborious assay for detecting macrolide resistance-associated mutations. The prevalence of resistance was 8.33% (6/72). To our knowledge, this is the first clinical evaluation of the MG-TMA CE-IVD assay. The MG-TMA assay performed on the automated Panther® system is a very sensitive and specific method for the detection of M. genitalium in clinical specimens.

Publisher URL: https://www.ncbi.nlm.nih.gov/pubmed/28794183

DOI: PubMed:28794183

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