The GeneProof Legionella pneumophila PCR Kit is a CE IVD certified diagnostic test designed to enable reliable detection of Legionella sp. The kit is secured by targeting the multicopy sequence of the 16S rRNA gene, which provides high sensitivity in the detection of Legionella sp. The kit has a simple laboratory workflow and is easily combinable with other GeneProof PCR kits in one workflow. The Master Mix in the kit contains Uracil-DNA glycosylase (UNG) and dUTPs, eliminating carryover contamination. The kit is compatible with a wide range of real-time PCR devices.
Instructions for Use
Declaration of Conformity
The GeneProof Legionella pneumophila PCR Kit is a highly sensitive and reliable diagnostic tool that targets the multicopy sequence of the 16S rRNA gene for secure detection of Legionella sp. With a simple laboratory workflow, this PCR kit can be easily combined with other GeneProof PCR kits in one workflow, saving valuable time and resources.
The kit’s 3-channel system enables the specific detection of Legionella sp., providing clinicians and laboratory technicians with accurate and reliable results. Additionally, the Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, eliminating the possibility of carryover contamination.
This CE IVD certified diagnostic test is compatible with a wide range of real-time PCR devices, making it accessible to laboratories worldwide. With its high sensitivity and contamination prevention measures, the GeneProof Legionella pneumophila PCR Kit is the ideal choice for diagnostic testing of Legionella sp.
|Indication||in vitro diagnostic medical device|
|Regulatory Status||CE IVD|
|Intended User||For professional use in laboratories with trained staff|
|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 201A 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 in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com|