GeneProof CT/NG/MG Multiplex PCR Kit
CE1023IVD
PRODUCT DETAIL
The PCR kit is designed for Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium 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 16S rRNA gene specific for C. trachomatis and in measurement of fluorescence increase. The N. gonorrhoeae detection consists in amplification of multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene and in measurement of fluorescence increase. The M. genitalium detection consists in amplification of a multicopy sequence of the gene encoding the 16S rRNA and in measurement of fluorescence increase. The C. trachomatis presence is indicated by the FAM fluorophore, N. gonorrhoeae by Cy5 fluorophore and M. genitalium by Texas Red 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 by 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 sequence and the 16S rRNA gene for Chlamydia trachomatis the 16S rRNA gene and porA pseudogene for Neisseria gonorrhoeae the 16S rRNA gene for Mycoplasma genitalium |
| Analytical Specificity | Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.177 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell) reaches up to 0.22 cp/μl with the probability of 95 % (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell) reaches up to 1.129 cp/μl with the probability of 95 % (on Amplirun® Mycoplasma genitalium DNA control, Vircell) |
| Diagnostic Specificity | 96.89 % (CI95%: 93.04% - 98.73%) |
| Diagnostic Sensitivity | 97.67 % (CI95%: 86.20% - 99.88%) |
| Extraction/Inhibition Control | PCR inhibition control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | swab, urine |
| 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 7500 Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System Mic qPCR Cycler QuantStudioTM 5 Real-Time PCR System Rotor-Gene 3000 / Q |
| Required Detection Channels | FAM, HEX, Cy5, Texas Red |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
| Regulatory Status | CE1023IVD |
* Validated instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof CT/NG/MG Multiplex PCR Kit | CNMX/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof CT/NG/MG Multiplex PCR Kit | CNMX/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof CT/NG/MG Multiplex PCR Kit | CNMX/ISEX/100 | real-time PCR | 100 reactions |