GeneProof Chlamydia trachomatis PCR Kit

GeneProof Chlamydia trachomatis PCR Kit

CE1023 IVD


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.


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 spermswab, 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


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

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