GeneProof Factor II Prothrombin PCR Kit
Kat.: FII/100
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A II. véralvadási faktor (prothrombin) G20210A polimorfizmusára specifikus, ‘Ready-To-Use’, egyetlen csöben lévő PCR master mix. (100 reakció)
Leírás
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
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| Technology | real-time PCR |
| Type of Analysis | qualitative |
| Target Sequence | G20210A Polymorphism of Factor II Prothrombin |
| Analytical Sensitivity (LoD) | reaches up to 2 ng/μl |
| Negative Percentage Agreement | 100 % (CI95%: 93.05 % – 100 %) |
| Positive Percentage Agreement | 100 % (CI95%: 82.83 % – 100 %) |
| Overall Percentage Agreement | 100 % (CI95%: 94.84 % – 100 %) |
| Validated Specimen | whole blood |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System Applied Biosystems 7300 / 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 Mic qPCR Cycler QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000/6000/Q* 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 |
* In Rotor-Gene Instruments leave all available detection channels on.
