Urinary disease test kit UroGen ELITe MGB®

Ureaplasma urealyticumUreaplasma parvummycoplasma hominis

Mycoplasma hominis (MH), Ureaplasma urealyticum (UU), and Ureaplasma parvum (UP) are bacteria involved in urogenital tract infections, associated with serious health complications. If left undetected, they can lead to diseases such as pelvic inflammatory disease, preterm birth, and infertility. Simultaneous detection of these bacteria through molecular testing methods is crucial to ensure appropriate treatment. The UroGen ELITe MGB® Kit is a multiplex PCR assay designed to detect and differentiate the DNA of MH, UU, and UP. It is CE-IVD validated for use with first-void urine samples and cervical-vaginal swab samples, in combination with the fully automated ELITe InGenius® and ELITe BeGenius® systems. The assay also allows for bacterial load evaluation by calculating defined Ct value intervals for each target. - Conserved targets: - Mycoplasma hominis - Ureaplasma urealyticum - Ureaplasma parvum - 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® and ELITe BeGenius® - High performance: - Example of clinical performance obtained on cervical and vaginal swabs - Mycoplasma hominis: 99.4% clinical sensitivity and 98.1% clinical specificity - Ureaplasma urealyticum: 98.8% clinical sensitivity and 94.1% clinical specificity - Ureaplasma parvum: 100% clinical sensitivity and 93.6% clinical specificity - Example of clinical performance obtained on first void urine - Mycoplasma hominis: 100% clinical sensitivity and 100% clinical specificity - Ureaplasma urealyticum: 99.3% clinical sensitivity and 98.1% clinical specificity - Ureaplasma parvum: 98.7% clinical sensitivity and 94.5% 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: - STI PLUS ELITe MGB® Kit, HSV1/2 ELITe MGB® Kit, HR – HPV ELIte Panel and Macrolide-R/MG ELITe MGB® Kit - Multiplex PCR assay for simultaneous detection and differentiation of Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum - CE-IVD validated for first-void urine and cervical-vaginal swab samples - Compatible with ELITe InGenius® and ELITe BeGenius® systems - Allows bacterial load evaluation via Ct value intervals - Includes exogenous and endogenous internal controls - Monoreagent, ready-to-use format - High clinical sensitivity and specificity demonstrated on both swab and urine samples - Minimal hands-on time: less than 2 minutes per sample - Supports additional testing from the same eluate