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Instructions for Use
Declaration of Conformity
Introducing the GeneProof Bordetella PCR Kit – the ultimate solution for detecting both Bordetella pertussis and Bordetella parapertussis in a single reaction tube. This kit is specifically designed to provide more information with fewer samples, saving time and resources for your laboratory.
The highly specific detection of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis) ensures accurate and reliable results every time, with no false-positive results for Bordetella holmesii.
The GeneProof Bordetella PCR Kit features a single tube Ready-to-Use Master Mix that contains all components for PCR amplification, eliminating the need for additional pipetting of PCR reagents, making it easy to use and simplifying your laboratory workflow. The Master Mix also contains Uracil-DNA glycosylase (UNG) and dUTPs, eliminating carryover contamination, ensuring the accuracy of your results.
This CE IVD certified diagnostic test is also compatible with a wide range of real-time PCR devices, making it a versatile and practical solution for your laboratory. What’s more, the GeneProof Bordetella PCR Kit is easily combinable with other GeneProof PCR kits in one workflow, ensuring efficient use of your laboratory resources.
|in vitro diagnostic medical device
|For professional use in laboratories with trained staff
|Type of Analysis
|The multi-copy insertion sequences IS1002 (specific for bothBordetella pertussis/parapertussis) and IS10001 (specific only for B. parapertussis)
|B. pertussis, 100 %
B. parapertussis, 100 %
|Analytical Sensitivity (LoD with 95% probability)
|0.212 cp/µl (on Amplirun® Bordetella pertussis DNA control, Vircell)
|PCR inhibition and DNA extraction efficiency control
|Aspirate, sputum, swab
|-20 ± 5 °C
|Validated Extraction Methods
|croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
|croBEE Real-Time PCR System
AriaMx Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
BioQuant-96 Real-Time PCR Systemm
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
|FAM, HEX/JOE/VIC, Cy5
|External Quality Assessment
|Regularly tested in QCMD and Instand e.V. External Quality Assessment panels – for results see www.geneproof.com