GeneProof Neisseria gonorrhoeae PCR Kit
Kat.: NG/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A N. gonorhoeae, beleértve a porA pszeudogén mutánsainak detektálására alkalmas ‘Ready-to-Use ‘ master mix. A 16S rRNS-t és az N. gonorrhoeae-re specifikus porA pszeudogént kódoló gén többkópiás szekvenciáját detektálja. (25 reakció)
Leírás
PRODUCT ADVANTAGES
DUAL TARGET DETECTION
- Dual target detection of the 16S rRNA gene and the porA pseudogene
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of the 16S rRNA gene
RELIABLE DETECTION OF porA MUTANT
- Elimination of false-negative results caused by a sequence variation in the porA pseudogene
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 | a multi-copy sequence of the gene encoding 16S rRNA and porA preudogene specific for N. gonorrhoeae |
| Analytical Specificity | N. gonorhoeae, including mutants in porA pseudogene, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.109 cp/µl with the probability of 95% (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell) |
| Extraction / Inhibition Control | PCR Inhibition and DNA extraction efficiency control |
| Validated Specimen | sperm, 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 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System StepOneTM / StepOnePlusTM Real-Time PCR System QuantStudio™ 3 / 5 Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| Certification | CE IVD |
