GeneProof Mycobacterium tuberculosis PCR Kit
Kat.: MT/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Mycobacterium tuberculosis komplex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti) tagjainak detektálására alkalmas ‘Ready-to-Use ‘ master mix. Csak az M. tuberculosis komplexen belüli fajokban található többkópiás IS6110 szekvenciát célozza meg. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY
- Secured by targeting the multi-copy sequence IS6110 found only in the species within the M. tuberculosis complex
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
HIGH SPECIFICITY
- Detection of all species from Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti)
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 | specific multi-copy insertion sequence IS6110 |
| Analytical Specificity | Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100% |
| Analytical Sensitivity (LoD) | reaches up to 0.191 cp/µl with the probability 95 % (on Amplirun® Mycobacterium tuberculosis DNA control, Vircell) |
| Extraction / Inhibition Control | PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | BAL, CSF, sputum, stool, swab, urine |
| 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 / 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 Control | regularly tested by the QCMD and Instand e. V. External Quality Assessment Panels – results at www.geneproof.com |
| Certification | CE IVD |
*Validated instruments
