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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 |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE1023IVD |
Intended User | For professional use in laboratories with trained staff |
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 with 95% probability) |
0.177 cp/μl (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%) |
Validated Specimen | Swab, urine |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Detection Channels | FAM, HEX, Cy5, Texas Red |
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
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