GeneProof Mycoplasma pneumoniae PCR Kit
Kat.: MP/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az M. pneumoniae detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az M181 gén többkópiás szekvenciáját detektálja. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY AND SPECIFICITY
- Secured by targeting the multicopy sequence of the M181 gene
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
UNIVERSAL PCR PROFILE
- Enables rapid and sensitive detection of disease-causing agents of atypical pneumoniae
- Beneficial in combination with GeneProof Chlamydia pneumoniae PCR Kit and GeneProof Bordetella pertussis/parapertussis PCR Kit
- 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 | the M181 gene encoding the CARDS toxin |
| Analytical Specificity | M. pneumoniae, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.46 cp/μl with the probability of 95 % |
| Extraction/Inhibition Controls | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | BAL, sputum, swab |
| 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 Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com |
| Certification | CE IVD |
* Validated instruments
