The GeneProof Chlamydia pneumoniae PCR Kit is a diagnostic tool for the differential diagnosis of atypical bacterial respiratory pathogens, with high sensitivity secured by targeting the ompA gene. The kit is easily combinable with other GeneProof PCR kits, features a single tube Ready-to-Use Master Mix for easy use, and contains Uracil-DNA glycosylase and dUTPs to eliminate possible carryover contamination. It is a CE1023IVD certified diagnostic test, compatible with a wide range of real-time PCR devices.
Instructions for Use
Declaration of Conformity
Introducing the GeneProof Chlamydia pneumoniae PCR Kit – the ultimate solution for the differential diagnosis of atypical bacterial respiratory pathogens. The kit targets the ompA gene, ensuring high sensitivity and accuracy in identifying Chlamydia pneumoniae.
The GeneProof Chlamydia pneumoniae PCR Kit is easily combinable with the GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Legionella pneumophila PCR kit, making it a versatile and practical solution for your laboratory.
Featuring a single tube Ready-to-Use Master Mix, this kit contains all the components for PCR amplification, eliminating the need for additional pipetting of PCR reagents, simplifying your laboratory workflow, and making it easy to use.
The GeneProof Chlamydia pneumoniae PCR Kit also contains Uracil-DNA glycosylase (UNG) and dUTPs in the Ready-to-Use Master Mix, which eliminates possible carryover contamination, ensuring the accuracy and reliability of your results.
This CE1023IVD certified diagnostic test is also compatible with a wide range of real-time PCR devices, making it a versatile and practical solution for your laboratory. Don’t settle for anything less than the best – order your GeneProof Chlamydia pneumoniae PCR Kit today and experience the accuracy and reliability of our diagnostic tool.
|Indication||in vitro diagnostic medical device|
|Intended User||For professional use in laboratories with trained staff|
|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|