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 |
| Validated 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 SystemRequired Detection ChannelsFAM, HEXExternal Quality Assessementregularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.comRegulatory StatusCE1023 IVD for in vitro Diagnostic Use
* Validated instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Chlamydia pneumoniae PCR Kit | CHP/ISIN/025 | real-time PCR | 25 reactions |
| GeneProof Chlamydia pneumoniae PCR Kit | CHP/ISIN/025 | real-time PCR | 50 reactions |
| GeneProof Chlamydia pneumoniae PCR Kit | CHP/ISIN/100 | real-time PCR | 100 reactions |
| 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 |