GeneProof MTHFR C677T PCR Kit
Kat.: M677/100
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A metiltetrahirdofolsavreduktáz gén (MTHFR) C677T mutációjára 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 |
| Regulatory Status | CE IVD / EC Directive 98/79/EC |
| Intended User | For professional use in laboratories with trained staff |
| Technology | real-time PCR |
| Type of Analysis | qualitative |
| Target Sequence | C677T mutation in the gene for methylenetetrahydrofolate reductase (MTHFR) |
| Analytical Sensitivity (LoD) | Reaches up to 2 ng/µl |
| Positive Percentage Agreement | 100 % (CI95%: 78.12 % – 100 %) |
| Negative Percentage Agreement | 100 % (CI95%: 69.87 % – 100 %) |
| Negative Percentage Agreement | 100 % (CI95%: 69.87 % – 100 %) |
| Overall Percentage Agreement | 100 % (CI95%: 85.87 % – 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 AMPLilab Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LineGene 9600 Plus Rotor-Gene 3000/6000/Q* |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | regularly tested by Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
* In Rotor-Gene instruments leave all available detection channels on.
