GeneProof CT/NG/MG Multiplex PCR Kit
Kat.: CNMX/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Chlamydia trachomatis, Neisseria gonorrhoeae és a Mycoplasma genitalium egyetlen reakciócsőben történő detektálására alkalmas ‘Ready-to-Use ‘ master mix. A detektált szekvenciák: a Chlamydia trachomatis kriptikus plazmid szekvenciáját és a 16S rRNS génjét; a Neisseria gonorrhoeae 16S rRNS gént és a porA pszeudogént; Mycoplasma genitalium 16S rRNS génjét. (25 reakció)
Leírás
PRODUCT ADVANTAGES
MORE INFORMATION WITH LESS SAMPLES
- PCR Kit detects the most important STI pathogens in a single reaction tube:
Chlamydia trachomatis
Neisseria gonorrhoeae
Mycoplasma genitalium
DETECTS porA MUTANT OF N. GONORRHOEAE
- Dual target detection of 16S rRNA gene and porA pseudogene
SWEDISH VARIANT OF C. TRACHOMATIS
- Dual target detection of 16S rRNA gene and cryptic plasmid
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| 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) | 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 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 Applied Biosystems 7500 Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System AriaMx Real-Time PCR System LineGene 9600 Plus 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 |
| Certification | CE1023 IVD |
