GeneProof Factor V Leiden PCR Kit

CE IVD

thrombotic mutations

 

PRODUCT DETAIL

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 MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.

 

 

TECHNICAL SPECIFICATION

Technology real-time PCR
Type of Analysis qualitative
Target Sequence G1691A polymorphism of factor V Leiden
Sensitivity reaches up to 2 ng/µl 
Diagnostic Specificity 100 %
Diagnostic Sensitivity  100 %
Evaluation G/G – standard homozygote (wild-type)
A/A – mutant homozygote
G/A – heterozygote
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 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 Plus

Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required detection channels FAM, HEX
Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by Instand e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD for in vitro Diagnostic Use

*Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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
GeneProof Factor V Leiden PCR Kit FV/025 real-time PCR 25 reactions