PRODUCT

Macrolide – R/MG ELITe MGB®Kit

Mycoplasma genitalium is a major bacteria involved in Sexually Transmitted Infections (STI), and responsible for serious health outcomes if left untreated. The rate of M. genitalium resistant to macrolide, the first line antibiotic treatment, is dramatically increasing. The detection of M. genitalium along with its macrolide-resistance with molecular methods is now recommended by European guideline to provide the right treatment. Macrolide-R/MG ELITe MGB® Kit is a multiplex PCR assay designed to detect and differentiate Mycoplasma genitalium and the 7 mutations: A2058C, A2058G, A2058T, A2059C, A2059G, A2062G, A2062F, associated with its macrolide-resistance in one single reaction. The assay is CE-IVD validated on urine in combination with ELITe InGenius®, a fully automated sample-to-result solution. Validation are ongoing with cervical, and vaginal swabs.

Benefits

Conserved targets
  • M. genitalium – 23S rRNA gene
  • 7 mutations: A2058C, A2058G, A2058T, A2059C, A2059G, A2062G, A2062F, associated with macrolide-resistance by melt-curve analysis
Easy-to-use
  • Monoreagent, ready-to-use
Best-in class PCR technology
  • ELITe MGB probes designed with Minor Groove Binder, Superbases® and Eclipse® Dark Quencher
Sample
  • Urine
Integrated workflow
  • Fully automated process including extraction, amplification and result analysis with ELITe InGenius
High performance
  • M. genitalium: 100% clinical sensitivity and 100% clinical specificity
  • Macrolide-R: 100% clinical sensitivity and 100% clinical specificity
Eluate storage
  • Additional testing including multiple PCR from the same eluate, retesting or archiving
Minimal hands-on time
  • Less than 2 minutes per sample from extraction to result analysis
Complete STI menu
  • HSV1/2 ELITe MGB® Kit, HR -HPV ELIte Panel, STI PLUS ELITe MGB® Kit and CHLAMYDIA tr. ELITe MGB® Kit

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