In vitro diagnostic kit for the simultaneous detection of the G20210A mutation in the prothrombin gene (FII) and the G1691A mutation in Factor V using real-time PCR.

Detailed description

Operating principle

The assay is based on the real-time PCR (Real-Time PCR) amplification of specific regions of the FII and FV factor genes containing the mutations of interest. It uses TaqMan® hydrolysis probes labelled with fluorophores (FAM, HEX, ROX and Cy5) that enable allelic discrimination. The fluorescent signal generated during amplification is proportional to the amplified DNA and enables genotype determination.

Clinical applications

Qualitative detection of the G20210A (FII) and G1691A (Factor V Leiden) mutations, associated with the risk of venous thrombosis and inherited thrombophilia.

Key aspects and benefits

Multiplex detection: both mutations are detected simultaneously in a single reaction (G20210A and G1691A).
High specificity
Clear fluorescence-based interpretation
Compatible with multiple real-time PCR instruments

Key indicators

100% Concordance
100% Repeatability and reproducibility
High Analytical specificity

Intended users

Technical personnel trained and qualified in molecular biology and genetic analysis in specialised clinical laboratories.

Considerations or limitations

Detects only the specified mutations Variants in primer- or probe-binding regions may affect the interpretation of results. The results must be used together with other clinical and laboratory data.
Presentation details
Available references
GVS-FIIFV-24 24 tests.
GVS-FIIFV-48 48 tests.
GVS-FIIFV-96 96 tests (on request).
Kit contents: each kit contains Master Mix, the primer mixture (Primer Mix), controls (WT and MUT), and a reaction blank (Reaction Blank).
Storage conditions: Store between -30°C and -18°C.

Area:

Hematology
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