GeneProof Chlamydia trachomatis PCR Kit
Kat.: CHT/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Chlamydia trachomatis, beleértve a deléciós mutációkat a kriptikus plazmidban (mint, a svéd változatot is), detektálására alkalmas ‘Ready-to-Use ‘ master mix. A kriptikus plazmid többkópiás szekvenciáját és a C. trachomatis 16S rRNS génjét detektálja. (25 reakció)
Leírás
PRODUCT ADVANTAGES
DUAL TARGET DETECTION
- Dual target detection of the 16S rRNA gene and a cryptic plasmid
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of the 16S rRNA gene
RELIABLE DETECTION OF SWEDISH VARIANT OF CHLAMYDIA TRACHOMATIS
- Elimination of false-negative results caused by a sequence variation in the cryptic plasmid
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 multi-copy sequence and the 16S rRNA gene for C. trachomatis |
| Analytical Specificity | Chlamydia trachomatis, including mutations with deletions in cryptic plasmid (including Swedish variant), 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.075 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell) |
| Diagnostic Specificity | 99.21 (CI95%: 99.07% – 99.34%) |
| Diagnostic Sensitivity | 100% (CI95%: 99.58% – 100%) |
| 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 | ccroBEE 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 DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System QuantStudio™ 3 / 5 Real-Time PCR System StepOne™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Control | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| Certification | CE1023 IVD |
