GeneProof Chlamydia pneumoniae PCR Kit

CE1023 IVD

PRODUCT DETAIL

The PCR kit is designed for Chlamydia pneumoniae detection by the real-time Polymerase Chain Reaction (PCR) method.

The C. pneumoniae detection consists in amplification of a specific conservative DNA sequence of a single-copy
ompA gene and in measurement of fluorescence increase. The C. pneumoniae presence is indicated by the FAM
fluorophore fluorescence growth. 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 specific conservative DNA sequence of a single-copy ompA gene
Analytical Specificity Chlamydia pneumoniae, 100 %
Analytical Sensitivity (LoD) reaches up to 0.647 cp/µl with the probability of 95 % (on Amplirun®
Chlamydia pneumoniae DNA control, Vircell)
Diagnostic Specificity 100 % (CI95 %: 97.50 % - 100.00 %)
Diagnostic Sensitivity 98.81 % (CI95 %: 92.62 % - 99.94 %)
Extraction/Inhibition Control PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)
Validated Specimen BAL, 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*
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
StepOne™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessement regularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status CE1023 IVD for in vitro Diagnostic Use

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/025 real-time PCR 25 reactions
GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/050 real-time PCR 50 reactions
GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/100 real-time PCR 100 reactions