LAMP Human FII&FVL duplex KIT
The LAMP Human FII&FVL duplex KIT is an in vitro diagnostic test intended for the qualitative detection of the Factor II G20210A and the Factor V Leiden G1691A polymorphisms by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA. This assay is dedicated to professional use in diagnostic laboratories. The device is not for self-testing.
Regulatory Status: CE-IVD
Format: 24 / 96 reactions
Linked disease: Thrombophilia
Mutation: c.*97G>A (G20210A or 20210G>A) | c.1601G>A (G1691A)
Method: LAMP + meting curve analysis
Sample: EDTA whole blood - no DNA extraction required - or extracted DNA
Compatible instruments: LightCycler 480 I&II / Cobas z 480 (Roche); CFX96 / CFX Opus 96 (Bio-Rad); QuantStudio 1/3/5 & 6/7 Flex (Applied Biosystems); MIC qPCR (Bio Molecular Systems); LC-Genie III & Genie HT (Optigene)
Software / result interpretation: Automated genotype calling via GeneFox software; mandatory visual confirmation of the melting curve
Turn around time: < 1h
General information
Advantages
Linked products
The LC-FII&FVL-LP kit uses loop mediated isothermal amplification, a robust amplification method using four to six primers per target, that can be directly used on EDTA-whole blood samples, without DNA purification and on extracted DNA samples from whole blood samples.
The genotyping is performed by melting curve analysis after amplification, using a specific probe and quencher for each target SNP.
Test principle
The primary genetic causes for inherited thrombophilia are mutations in the genes for Factor II (prothrombin) and Factor V Leiden.
Factor II mutation c.*97G>A (G20210A or 20210G>A) is located in the gene promotor region and is associated with elevated plasma levels of prothrombin, resulting in an increased risk of blood clot formation. The Allele Frequency of the mutated allele is around 2% in the Caucasian population.
Factor V Leiden thrombophilia is characterized by a poor anticoagulant response to activated protein C (APC) and an increased risk for venous thromboembolism (VTE). The allele frequency of Factor V Leiden polymorphism is 3-8% in the Caucasian population.
Background Information
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