GeneProof Chlamydia trachomatis PCR Kit
CE1023 IVD
PRODUCT DETAIL
The PCR kit is designed for Chlamydia trachomatis detection by the real-time Polymerase Chain Reaction (PCR) method.
The C. trachomatis detection consists in amplification of both the cryptic plasmid multi copy sequence and the gene encoding 16S rRNA specific for C. trachomatis and in measurement of fluorescence increase. Detection of multi copy sequence of the cryptic plasmid enables very high sensitivity of Chlamydia detection (including the Swedish variant) and the chromosomal gene detection at the same time enables high specificity and makes detection of plasmidless strains possible. The C. trachomatis 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 | the cryptic plasmid multi-copy sequence and the 16S rRNA gene for C. trachomatis |
| Analytical Specificity | Chlamydia trachomatis, including mutations with deletions in cryptic plasmid (including Swedish variant), 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.075 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell) |
| Diagnostic Specificity | 99.21 % (CI95 % : 99.07 % - 99.34 %) |
| Diagnostic Sensitivity | 100 % (CI95 % : 99.58 % - 100 %) |
| Extraction/Inhibition Control | PCR inhibition control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | sperm, swab, urine |
| 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 DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus |
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ 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 trachomatis PCR Kit | CHT/ISIN/025 | real-time PCR | 25 reactions |
| GeneProof Chlamydia trachomatis PCR Kit | CHT/ISIN/050 | real-time PCR | 50 reactions |
| GeneProof Chlamydia trachomatis PCR Kit | CHT/ISIN/100 | real-time PCR | 100 reactions |
| GeneProof Chlamydia trachomatis PCR Kit | CHT/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Chlamydia trachomatis PCR Kit | CHT/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Chlamydia trachomatis PCR Kit | CHT/ISEX/100 | real-time PCR | 100 reactions |