02 Details

STI PLUS ELITe MGB®Kit

Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas Vaginalis are major bacteria involved in sexually transmitted infections (STI), and responsible for serious health outcomes. Left unidentified, these bacteria can cause similar diseases and similar complications including ectopic pregnancy and infertility. Simultaneous detection of these pathogens with molecular testing methods is important to provide the right treatment. STI PLUS ELITe MGB® Kit is a multiplex PCR assay designed to detect and differentiate Chlamydia trachomatis, including the Swedish variant, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis DNAs. The assay is CE-IVD validated on first void urine samples collected without preservatives and cervical-vaginal swab samples in combination with ELITe InGenius®, a fully automated sample-to-result solution.

 

Benefits

Conserved targets
  • C .trachomatis (cryptic plasmid, and chromosomic sequences)
  • N. gonorrhoeae
  • M. genitalium
  • T. vaginalis
  • 2 Internal controls: exogenous and endogenous for cellularity control
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
Large range of samples
  • Urine, cervical and vaginal swabs
Integrated workflow
  • Fully automated process including extraction, amplification and result analysis with ELITe InGenius
High performance Example of clinical performance obtained on cervical and vaginal swabs

  • C. trachomatis: 99% clinical sensitivity and 100% clinical specificity
  • N. gonorrhoeae: 100% clinical sensitivity and 100% clinical specificity
  • M. genitalium: 100% clinical sensitivity and 100% clinical specificity
  • T. vaginalis: 98.4% 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, CHLAMYDIA tr. ELITe MGB® Kit and Macrolide-R/MG ELITe MGB®Kit

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