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GeneProof Chlamydia pneumoniae PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY

  • Secured by targeting the ompA gene

DIAGNOSTICS OF ATYPICAL PNEUMONIAE

  • Differential diagnostics of atypical bacterial respiratory pathogens
  • Easily combinable with GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Legionella pneumophila PCR kit

EASY-TO-USE CONCEPT

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

CONTAMINATION PREVENTION

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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE1023IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/025 real-time PCR 25 reactions
GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_CHP_QCMD_07_21_EN_02
pdf, [148.7 kB]
; GP_CHP_QCMD_07_21_EN_01
pdf, [148.27 kB]
; GP_CHP_Instand_06_2021_EN
pdf, [901.22 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
Regulatory Status CE1023IVD
Technology real-time PCR
Type of Analysis qualitative
Target Sequence specific conservative DNA sequence of a single-copy ompA gene
Analytical Specificity C. pneumoniae, 100 %
Analytical Sensitivity (LoD) 0.647 cp/µl with the probability of 95 % (on Amplirun® Chlamydia pneumoniae DNA control, Vircell)
Diagnostic Specificity 100% (CI95%: 95.01% - 100.00%)
Diagnostic Sensitivity 99.08% (CI95%: 94.26% - 99.95%)
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
Validated Specimen BAL, 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
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
BioQuant-96 Real-Time PCR System

Detection Channels FAM, HEX
External Quality Control regularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_CHP_Advisory Notice_EN_CZ
pdf, [273.24 kB]
; GP_CHP_Advisory_Notice_05_22_EN
pdf, [508.72 kB]
; GP_CHP_Instruction_for_Use_EN
pdf, [201.26 kB]
; GP_CHP_Instruction_for_Use_ES
pdf, [221.06 kB]
; GP_CHP_Instruction_for_Use_FR
pdf, [241.47 kB]

Declaration of Conformity

; GP_CHP_Declaration_of_Conformity_EN
pdf, [585.93 kB]
; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]

MSDS

; GP_CHP_Safety_Data_Sheet_EN
pdf, [275.22 kB]

PCR Template

; GP_Chlamydia pneumoniae_Mic
micassay, [21.96 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]

Product Leaflet

; GP_CHP_Leaflet_EN
pdf, [138.12 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 2.0_EN
pdf, [1.8 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]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.