GeneProof Factor II Prothrombin PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed to detect G20210A polymorphism of the gene for human factor II prothrombin 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 the single nucleotide guanine/adenine polymorphism in site 20210 (G20210A). Presence of wild-type allele (G20210G) is detected in the FAM fluorescent channel and mutant allele (A20210A) in the HEX fluorescent channel. In case of heterozygous genotype (G20210A) 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 | G20210A polymorphism of factor II prothrombin |
| Analytical Sensitivity | reaches up to 2 ng/µl |
| 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 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System 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 |
| External Quality Assessment | regularly tested by Instand e.V. External Quality Assessment panels – results at www.geneproof.com |
| Regulatory Status | CE IVD for in vitro Diagnostic Use |
* Validated Instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Factor II Prothrombin PCR Kit | FII/050 | real-time PCR | 50 reactions |
| GeneProof Factor II Prothrombin PCR Kit | FII/100 | real-time PCR | 100 reactions |