GeneProof Factor V Leiden PCR Kit
CE IVD
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 |
| Validated 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 PlusMic 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 |
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 |