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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof CT/NG/MG Multiplex PCR Kit | CNMX/ISEX/025 | real-time PCR | 25 reactions |
GeneProof CT/NG/MG Multiplex PCR Kit | CNMX/ISEX/100 | real-time PCR | 100 reactions |
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) |
Diagnostic specificity | 96.89% (CI95%: 93.04% – 98.73%) |
Diagnostic sensitivity | 97.67 % (CI95%: 86.20% – 99.88%) |
Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control |
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* |
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 |
Certification | CE1023 IVD |
* Validated instruments
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support@geneproof.com
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