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GENERI BIOTECHModel gb HEMO FV (G1691A) - IVD Kit for Thrombophilic Mutations

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This in vitro diagnostic kit is intended for detection of mutation G1691A (Leiden) in coagulation factor V in human genomic DNA. Detection is based on real-time polymerase chain reaction (qPCR) using fluorescently labelled probes (allelic discrimination).

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Coagulation factor V is a plasmatic glycoprotein involved in the process of blood coagulation. In its activated form, factor V participates in the conversion of prothrombin to thrombin which contributes to the creation of blood clots. Mutation G1691A (so-called Leiden mutation) causes replacement of amino acid arginine by glutamine in the position 506 of the factor V protein chain.

The frequency of the Leiden mutation in the healthy European population ranges between 3–5 %, whereas in patients who suffer from thromboembolic events (TEN) this frequency is about 20–40 %. The risk of venous thrombosis increases 3–10× in patients with heterozygote genotype and 20–80× in mutated homozygotes.

  • ready-to-use assay
  • sample concentration 1-100 ng/µl
  • positive and negative controls included
  • FAM and HEX channels detection
  • identical amplification profile as gb HEMO, gb GENETIC, gb PHARM kits

ABI 7500/7500 Fast (ABI)

ABI 7900HT (ABI)

AriaMx (Agilent Technologies)

CFX96/96Touch (Bio-Rad)

iCycler iQ5 (Bio-Rad)

Light Cycler 480/Cobas z480 (Roche Diagnostics)

MIC (BMS)

QuantStudio 5 (Applied Biosystems)

RG 3000 (Corbett Research)

RG 6000/Q (Corbett Research/Qiagen)

SmartCycler (Cepheid)

Stratagene Mx3000P/Mx30005P (Agilent Technologies)

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