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GeneProof Factor V Leiden PCR Kit

CE IVD

The PCR kit is designed to detect G1691A polymorphism in the gene for human factor V Leiden by the real-time Polymerase Chain Reaction (PCR) method.

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is a single nucleotide guanine/adenine polymorphism in site 1691 (G1691A). Presence of wild-type allele (G1691G) is detected in the FAM fluorescent channel and mutant allele (A1691A) in the HEX fluorescent channel. In case of heterozygous genotype (G1691A) a signal is detected in both channels. Detection kit contains Ready-to-Use Master Mix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.

 

PRODUCT ADVANTAGES

 

SINGLE TUBE READY-TO-USE MASTER MIX

  • Contains all components for PCR amplification
  • Reduces the need of qualified laboratory staff
  • Enables quick and reliable results


UNIVERSAL PCR PROFILE

  • Uniform reaction format
  • All PCR Kits from the group Thrombotic Mutations are easily combinable with each other
  • Simplifies laboratory workflow

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Factor V Leiden PCR Kit FV/025 real-time PCR 25 reactions
GeneProof Factor V Leiden PCR Kit FV/050 real-time PCR 50 reactions
GeneProof Factor V Leiden PCR Kit FV/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_Instand_04.2018_EN
pdf, [145.01 kB]
GP_Instand_04.2019_EN
pdf, [297.76 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target Sequence G1691A polymorphism of factor V Leiden
Diagnostic Specificity 100 %
Diagnostic Sensitivity 100 %
Validated Specimen whole blood
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
LightCycler® 2.0 / 480
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LineGene 9600 Plus
Rotor-Gene 3000/6000/Q
SLAN® Real-Time PCR System
QuantStudio™ 3 / 5 Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System
Mic qPCR Cycler

Required Detection Channels FAM, HEX
External Quality Assessment regularly tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Certification CE IVD

* Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_Advisory Notice_EN
pdf, [177.45 kB]
GP_FV_Instruction for Use_CZ
pdf, [906.13 kB]
GP_FV_Instruction for Use_EN
pdf, [896.72 kB]

Declaration of Conformity

GP_FV_Declaration of Conformity_CZ
pdf, [235.68 kB]
GP_FV_Declaration of Conformity_EN
pdf, [247.67 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (genetic)_CZ
pdf, [1.64 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (genetic)_EN
pdf, [1.58 MB]
CFX 96/Connect/Dx Real-Time Detection System_EN
pdf, [1.89 MB]
CFX Connect/96/Dx Real-Time PCR Detection System_CZ
pdf, [1.93 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_CZ
pdf, [2.01 MB]
LightCycler 2.0_EN
pdf, [1.96 MB]
LightCycler 480/Instrument II_CZ
pdf, [2.1 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.03 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.28 MB]

Product Leaflet

GP_Thrombotic_Mutations_Leaflet_EN
pdf, [139.32 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Contact form 
+420 730 176 222
support@geneproof.com


FAQ

 

 

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