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The GeneProof Bordetella PCR Kit is a highly specific and reliable solution for detecting both Bordetella pertussis and Bordetella parapertussis in a single reaction tube, providing more information with fewer samples. The kit targets the multi-copy insertion sequences IS1002 and IS1001, ensuring accurate and reliable results with no false-positive results for Bordetella holmesii. The kit has a single tube Ready-to-Use Master Mix that eliminates the need for additional pipetting of PCR reagents, making it easy to use and simplifying laboratory workflow. The Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, eliminating carryover contamination, ensuring accurate and reliable results. The kit is CE IVD certified and compatible with a wide range of real-time PCR devices, making it a versatile and practical solution for your laboratory. The GeneProof Bordetella PCR Kit can also be easily combined with other GeneProof PCR kits, ensuring efficient use of laboratory resources.
Instructions for Use
Declaration of Conformity
MSDS
Publications
Manual
PCR Templates
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.
| Indication | in vitro diagnostic medical device |
| Regulatory Status | CE IVD |
| Intended User | For professional use in laboratories with trained staff |
| Technology | Real-time PCR |
| Type of Analysis | Qualitative |
| Target Sequence | The multi-copy insertion sequences IS1002 (specific for bothBordetella pertussis/parapertussis) and IS10001 (specific only for B. parapertussis) |
| Analytical Specificity | B. pertussis, 100 % B. parapertussis, 100 % |
| Analytical Sensitivity (LoD with 95% probability) | 0.212 cp/µl (on Amplirun® Bordetella pertussis DNA control, Vircell) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | Aspirate, sputum, swab |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | 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 LightCycler® 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / Q SLAN® Real-Time PCR System |
| Detection Channels | 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 |
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