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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

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

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

 

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/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_BP_Leaflet_EN
pdf, [162.84 kB]
Choose all

EQA Panels

EQA results

; GP_BP_QCMD_09_20_EN_02
pdf, [197.16 kB]
; GP_BP_QCMD_09_20_EN_01
pdf, [198.71 kB]
; GP_BP_Instand_06_21_EN
pdf, [901.17 kB]
Choose all

Technical specification

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 both Bordetella 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

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_BP_Advisory_Notice_EN
pdf, [853.68 kB]
; GP_BP_Instructions_for_Use_ES
pdf, [171.82 kB]
; GP_BP_Instructions_for_Use_IT
pdf, [169.16 kB]
; GP_BP_Instruction_for_Use_EN
pdf, [285.03 kB]
; GP_BP_Instruction_for_Use_PT
pdf, [136.27 kB]

Declaration of Conformity

; GP_BP_Declaration_of_Conformity_EN
pdf, [573.69 kB]

MSDS

; GP_BP_Safety Data Sheet_EN
pdf, [274.64 kB]

Publications

; GP_RESPIRATORY_Publications_10_2022_EN
pdf, [142.69 kB]

PCR Template

; GP_Bordetella pertussis_parapertussis_Mic
micassay, [28.03 kB]
; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 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]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 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]
Files are available only for registered users.