P609 Clinical evaluation of three commercial PCR assays for the detection of mycoplasma genitalium and macrolide resistance

Background Because macrolide resistance is increasing worldwide in Mycoplasma genitalium (MG), it is recommended to detect macrolide resistance-associated mutations in MG-positive specimens. Some new commercial kits detect macrolide resistance at the same time as MG detection. The aim the study was to prospectively evaluate the clinical performance of three commercial kits for the detection of MG and macrolide resistance. Methods Two hundred MG-positive urogenital specimens detected using an in-house real-time PCR are prospectively collected at the Bacteriology Department of Bordeaux University Hospital (France). After DNA extraction of the specimens using the MagNa Pure 96 (Roche), the specimens are submitted to four assays: the SpeeDx ResistancePlus MG assay, the Diagenode S-DiaMGRES assay, the PathoFinder Real accurate TVMGRES and the in-house FRET qPCR assay and 23S rRNA sequencing used as reference. The internal controls of each kits were added in the specimen before extraction and the absence of amplification inhibition associated with the addition of the three internal controls was previously checked. Results To date, 114 MG-positive specimens have been analyzed. The clinical sensitivity for MG detection was similar for the three commercial kits, ranging between 95.5 and 98.2%. To compare the macrolide resistance detection performance, 90 specimens that have been found MG-positive using the three kits and that could be amplified using the in-house FRET qPCR assay were retained. Therefore, compared to the reference assay, clinical sensitivity of the three commercial kits for the detection of resistance was ranging between 89.1% and 100% and clinical specificity was ranging between 93.2 and 97.7%, with no statistical significant difference. Testing additional urogenital specimens will allow to specify these percentages. Conclusion The launch of three sensitive and specific commercial kits for the detection of MG and macrolide resistance will be useful to guide the choice of therapy. Disclosure No significant relationships.