PRODUCT

UroGen ELITe MGB® Kit

Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum are genital mycoplasmas commonly found in the human urogenital tract. While they may be present as commensal organisms, if left untreated, they have been associated with a variety of urogenital conditions, including non-gonococcal urethritis (NGU), pelvic inflammatory disease (PID), cervicitis, infertility, and complications during pregnancy. Due to their potential role in multiple pathological conditions, together with their frequent presence as part of the normal urogenital microbiota, determining their clinical significance can be challenging.

In this context, accurate detection and differentiation of these microorganisms are important components of clinical evaluation, supporting the diagnosis of patients with suspected urogenital infections and aiding clinical decision-making. UroGen ELITe MGB® Kit is a qualitative multiplex nucleic acids Real-Time PCR assay for the detection and identification of the genomic DNA of M. hominis, U. urealyticum and U. parvum, extracted from clinical specimens.

The assay is validated for use with ELITe InGenius® and ELITe BeGenius® instruments for urine and cervical-vaginal swab matrices.

Benefits

Target gene
  • gap gene (M. hominis)
    ureC gene (U. urealyticum)
    ureC gene (U. parvum)
Easy-to-use
  • Monoreagent, ready-to-use
Kit format
  • 96 tests (8 tubes x 12 tests each)
Analysis type
  • Qualitative
Validated matrices
  • Urine, cervical-vaginal swabs
Minimum sample volume required
  • 200 μl for all matrices
Sample-to-Result workflow
  • Fully automated process including extraction, amplification and result analysis with ELITe InGenius®, ELITe BeGenius®
Regulatory status
  • Whole process CE-IVD (IVDR) compliant
Trusted technology
  • ELITe MGB® probes designed with Minor Groove Binder technology, Superbases® and Eclipse® Dark Quencher.
Wide panel
  • Comprehensive solution for the investigation of sexually transmitted infections

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