GeneProof Legionella pneumophila PCR Kit
Kat.: LP/ISEX/100
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az L. pneumophila detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az e16S rRNS gén többkópiás szekvenciáját detektálja. (100 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of the 16S rRNA gene
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Respiratory Infections group
- Simplifies laboratory workflow
RELIABLE DETECTION OF LEGIONELLA SP.
- Enables detection of Legionella sp. using 3-channel system
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination
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 gene encoding 16S rRNA specific for L. pneumophila |
| Analytical Specificity | L. pneumophila, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.578 cp/μl with the probability of 95% (on Amplirun® Legionella pneumophila DNA control, Vircell) |
| 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 | ccroBEE 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 / 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
