GeneProof Bordetella pertussis/parapertussis PCR Kit

CE IVD

PRODUCT DETAIL

The PCR kit is designed for Bordetella pertussis and Bordetella parapertussis detection and differentiation by the    real-time Polymerase Chain Reaction (PCR) method.

The B. pertussis and B. parapertussis detection and differentiation consist in amplification of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis) and in measurement of fluorescence increase. GeneProof Bordetella pertussis/parapertussis PCR Kit is one of the few kits in the market that does not provide false positive results for Bordetella holmesii. The B. pertussis presence is indicated by the FAM fluorophore fluorescence growth only. The B. parapertussis presence is indicated by the fluorescence growth in both FAM and Cy5 channels. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (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 multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS10001 (specific only for B. parapertussis)
Specificity

B. pertussis, 100 %

B. parapertussis, 100 %

Sensitivity (LoD)
reaches up to 0.212 cp/µl with the probability 95 % (on Amplirun® Bordetella pertussis DNA control, Vircell)
Extraction/Inhibition Control

PCR inhibition control (ISIN version)

PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen

aspirate, sputum, swab

Storage

-20 ± 5 °C

Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Instruments

croBEE Real-Time PCR System*
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection 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

Required Detection Channels

FAM, HEX, Cy5

Quality control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels for results see www.geneproof.com
Certification CE IVD for in vitro diagnostics 

*Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/025 real-time PCR 25 reactions
GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/050 real-time PCR 50 reactions
GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/100 real-time PCR 100 reactions