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 |
Validated 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 SystemRequired Detection ChannelsFAM, HEX, Cy5Quality 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 - for results see www.geneproof.comCertificationCE IVD for in vitro diagnostics
ORDER INFORMATION
Product name | Cat. No. | Technology | Package |
GeneProof Bordetella pertussis/parapertussis PCR Kit | BP/ISIN/025 | real-time PCR | 25 reactions |
GeneProof Bordetella pertussis/parapertussis PCR Kit | BP/ISIN/050 | real-time PCR | 50 reactions |
GeneProof Bordetella pertussis/parapertussis PCR Kit | BP/ISIN/100 | real-time PCR | 100 reactions |
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 |