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MDR/MTB ELITe MGB® Kit

Tuberculosis is a major and underdiagnosed health issue commonly caused by species belonging to the Mycobacterium tuberculosis. The steady increase of resistant forms, caused by intensive use of frontline antibio­tics such as rifampicin and isoniazid, is particularly alarming and leads to massive treatment failure. Rapid and reliable detection of patients infected with MTB and resistance to rifampicin and isoniazid, is essential to determine the right therapy and limit the use of inappropriate treatments.

MDR/MTB ELITe MGB® Kit is a real-time PCR assay designed for the simultaneous detection of the DNA of Mycobacterium tuberculosis complex and resistance to rifampicin and isoniazid. The assay is validated in combination with ELITe InGenius®, a fully automated sample-to-result solution.

Benefits

Conserved targets· MTB Complex: IS6110 region repeated sequence
· Rifampicin resistance: rpoB gene hotspot region
· Isoniazid resistance: katG gene and inhA gene regions
· Internal control: artificial DNA sequence
Easy-to-use· Monoreagents, ready to use
Best-in class PCR technology· ELITe MGB® probes designed with Minor Groove Binder technology, Superbases® and Eclipse® Dark Quencher
Sample · Sputum
Integrated workflow· Fully automated process for extraction, amplification and result analysis with ELITe InGenius
High performance· 100% clinical sensitivity and 98% 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 respiratory infections menu· Complete respiratory infections range with Respiratory Viral ELITe MGB® Panel and Respiratory Bacterial ELITe MGB® Panel

Ordering Information

Product NameDescription Reference
MDR/MTB ELITe MGB Kit*TB1 Mix:4 tubes, 24 reactions each
TB2 Mix:4 tubes, 24 reactions each
RTS120ING
MDR/MTB ELITe Positive Control*3 tubes, 2 reactions each CTR120ING
CTRCPE – Internal Control4 tubes, 12 reactions each CTRCPE

*available soon

Adenovirus ELITe MGB® Kit

Adenoviruses are important causes of infections in both immunocompetent and immunocompromised individuals, and leading causes of morbidity and mortality, especially in children.
Latent adenovirus reactivation, or transmission during transplantation, can be responsible for disseminated infection and graft loss.
Adenovirus detection and viral load monitoring, by molecular methods, is essential to quickly set up an appropriate antiviral treatment and prevent serious complications.
Adenovirus ELITe MGB® Kit is a real-time PCR assay designed for the detection and quantification of Adenovirus DNA. The assay is CE-IVD validated on different sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

BKV ELITe MGB® Kit

BK Virus (BKV) is a highly prevalent and asymptomatic polyomavirus in the general population, and a major cause of renal infection in immunocompromised patients. Latent BKV is frequently reactivated after kidney and hematopoietic stem cell transplantation, leading to renal dysfunction and potentially graft loss. BKV viral load monitoring is crucial for patient management in order to prevent renal diseases and transplant failure.

BKV ELITe MGB® Kit is a real-time PCR assay designed for the detection and quantification of BK virus DNA. The assay is CE-IVD validated on diverse range of sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

C. difficile ELITe MGB® Kit

Clostridium difficile bacteria are major causes of healthcare associated infections, especially in the elderly or in patients treated by antibiotics. Intensive use of antibiotics can promote C. difficile expansion, leading to severe outcomes. Rapid detection of patients with Clostridium difficile infections in healthcare facilities is crucial, to isolate infected patients, provide an appropriate treatment and proceed to decontamination.

C. difficile ELITe MGB® Kit is a real-time PCR assay designed for the detection and the differentiation of Clostridium difficile toxins A and B DNA, including the hypervirulent epidemic NAP1/BI/027 strain. The assay is CE-IVD validated on stool, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

CMV ELITe MGB® Kit

Cytomegalovirus (CMV) is a highly prevalent herpesvirus in the general population and a leading cause of morbidity and mortality in immunocompromised patients. Latent CMV can be reactivated after solid organ or hematopoietic stem cell transplantation, and generate diverse and sometimes very severe infections. CMV diagnosis and viral load monitoring, especially by molecular methods, is important for patient management, in order to initiate and determine efficiency of anti-viral treatment.

CMV ELITe MGB® Kit is a real-time PCR assay, designed for the detection and quantification of Cytomegalovirus DNA. The assay is CE-IVD validated on a large range of sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

Coagulation ELITe MGB® Kit

Factor V, Factor II, and Methylene Tetrahydropholate Reductase (MTHFR) genes are involved in the coagulation system. Single nucleotide polymorphism variants (SNP) of those genes are associated with higher risk of thrombosis and embolisms. Variant detection by genetic testing is important in patients with hypercoagulability to provide adapted therapy.

Coagulation ELITe MGB® Kit is a real-time PCR assay designed for the detection and the allelic discrimination of the main variants associated with thrombosis and embolisms: Factor V G1691A (Leiden), Factor II G20210A and MTHFR C677T. The 3 variants are detected in one single reaction by melt-curve analysis. The assay is CE-IVD validated on blood samples, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

CRE ELITe MGB® Kit

Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria resistant to carbapenems, the antibiotics of “last resort”.  CRE are responsible for serious infections much more difficult to treat with higher morbidity and mortality in hospitals. Rapid and reliable Carbapenem-Resistant Enterobacteriaceae detection with molecular methods is crucial to identify infected patients, implement infection measure controls, and avoid outbreak in hospital and healthcare settings.

CRE ELITe MGB® Kit is a multiplex real-time PCR assay designed for the detection and the differentiation of all main relevant classes of Carbapenem-Resistant Enterobacteriaceae genes: KPC (serine carbapenemases genes), NDM, VIM, IMP (metallo beta-lactamases genes), and OXA-48 like (OXA carbapenemases genes). The assay is CE-IVD validated on different samples types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

EBV ELITe MGB® Kit

Epstein-Barr Virus (EBV) is a widespread herpesvirus, generally asymptomatic or sometimes responsible for mild infection like mononucleosis. After solid organ or hematopoietic stem cell transplant, EBV reactivation is a common cause of malignant transformation, called Post-Transplant Lymphoproliferative Disorder “PTLD”. EBV viral load monitoring is important to diagnose, and monitor such complications which are cared for by reducing the patient immunosuppressive treatment.

EBV ELITe MGB® Kit is a real-time PCR assay designed for the detection and quantification of Epstein-Barr virus DNA. The assay is CE-IVD validated on a large range of sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

Enterovirus ELITe MGB® Kit

Enteroviruses are ubiquitous viruses responsible for a wide range of mild and severe diseases, and leading causes of viral meningitis in both immunocompetent and immunocompromised patients.  Rapid meningitis testing is crucial, especially in transplant patients, to quickly set up an appropriate treatment for meningitis and rule out bacterial infection.

Enterovirus ELITe MGB® Kit is a one step, reverse-transcription and real-time PCR assay designed for the detection and quantification of Enterovirus RNA. The assay is CE-IVD validated on a large range of sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

ESBL ELITe MGB® Kit

Extended Spectrum Beta-Lactamases (ESBLs) are enzymes produced by enterobacteriaceae which are resistant to frequently used antibiotics as penicillin and cephalosporin. ESBL Enterobacteriaceae are responsible for serious infections more difficult to treat, with fewer effective antibiotics to use and higher patient morbidity and mortality. Such patients are generally treated with Carbapenems. Reliable detection of patients infected with resistant bacteria producing ESBLs, is essential to determine the right antibiotic and limit the use of inappropriate treatments.

ESBL ELITe MGB® Kit is a multiplex real-time PCR assay designed for the detection of CTX-M genes, the most prevalent group of ESBL genes in Enterobacteriaceae. The assay is CE-IVD validated on several sample matrices, in combination with ELITe InGenius®, a fully automated sample-to-result solution.