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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.

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Benefits

Conserved targets
  • Factor V: single nucleotide polymorphism G1691A Leiden region
  • Factor II: single nucleotide polymorphism G20210A region
  • MTHFR: single nucleotide polymorphism C677T region
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
Sample
  • Whole blood
Integrated workflow
  • Fully automated process for extraction, amplification and result analysis with ELITe InGenius
High performance
  • Factor V: 98.5% clinical sensitivity and 100% clinical specificity
  • Factor II: 100% clinical sensitivity and 100% clinical specificity
  • MTHFR: 100% 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

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