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GeneProof Bordetella pertussis/parapertussis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • Detects and distinguishes Bordetella pertussis and Bordetella parapertussis in a single reaction tube

UNIVERSAL PCR PROFILE 

  • Easily combinable with other PCR kits from the Respiratory Infections group, especially with GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Chlamydia pneumonia PCR Kit
  • Simplifies laboratory workflow

HIGHLY SPECIFIC DETECTION

  • Amplification of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis)
  • No false-positive results for Bordetella holmesii

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
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

EQA Panels

EQA results

GP_BP_QCMD_2018_EN
pdf, [191.13 kB]
GP_Instand_06.2018_EN
pdf, [617.11 kB]
GP_Instand_06.2019_EN
pdf, [416.54 kB]
GP_Instand_06.2020_EN
pdf, [323.72 kB]
Choose all

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)
Analytical Specificity

B. pertussis, 100 %
B. parapertussis, 100 %

Analytical 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 and DNA extraction efficiency control 

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

External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels for results see www.geneproof.com
Certification CE IVD

*Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_BP_Instruction for Use_EN
pdf, [551.88 kB]
GP_BP_Instruction for Use_ES
pdf, [213.9 kB]
GP_Declaration of Change_EN_CZ
pdf, [201.13 kB]

Declaration of Conformity

GP_BP_Declaration of Conformity_EN
pdf, [337.47 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]

Product Leaflet

GP_BP_Leaflet_EN
pdf, [159.11 kB]

PCR Template

GP_Bordetella pertussis_parapertussis_Mic_1
micassay, [28.03 kB]
Files are available only for registered users.