PRODUCT

UroGen ELITe MGB® Kit

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.
SSimultaneous 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.

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BENEFITS

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Benefits

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 specificit 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 specificit
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

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