GeneProof Legionella pneumophila PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for Legionella pneumophila detection by the real-time Polymerase Chain Reaction (PCR) method.
The L. pneumophila detection consists in amplification of the gene encoding 16S rRNA specific for L. pneumophila and in measurement of fluorescence increase. The L. pneumophila presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR reaction (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
TECHNICAL SPECIFICATION
Technology | real-time PCR |
Type of Analysis | qualitative |
Target Sequence | the gene encoding 16S rRNA specific for L. pneumophila |
Specificity | L. pneumophila, 100 % |
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 control (ISIN version)
PCR Inhibition and DNA extraction efficiency control (ISEX version) |
Validated specimen | BAL, sputum, swab |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Validated 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 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR SystemRequired Detection ChannelsFAM, HEXQuality Controlquality management system is certified in compliance with the requirements of the standard ISO 13485External Quality Assessmentregularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.comCertificationCE IVD for in vitro Diagnostics Use
ORDER INFORMATION
Product name | Cat. No. | Technology | Package |
GeneProof Legionella pneumophila PCR Kit | LP/ISIN/025 | real-time PCR | 25 reactions |
GeneProof Legionella pneumophila PCR Kit | LP/ISIN/050 | real-time PCR | 50 reactions |
GeneProof Legionella pneumophila PCR Kit | LP/ISIN/100 | real-time PCR | 100 reactions |
GeneProof Legionella pneumophila PCR Kit | LP/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Legionella pneumophila PCR Kit | LP/ISEX/050 | real-time PCR | 50 reactions |
GeneProof Legionella pneumophila PCR Kit | LP/ISEX/100 | real-time PCR | 100 reactions |