GeneProof Treponema pallidum PCR Kit
Kat.: TP/GP/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Treponema pallidum detektálására alkalmas ‘Ready-to-Use ‘ master mix. A DNS polimeráz I-et kódoló polA gén szekvenciáját detektálja. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGHLY SPECIFIC DETECTION
- Secured by highly conservative polA gene for DNA polymerase I
UNIVERSAL PCR PROFILE
- Simplifies laboratory workflow
- Easily combinable with other PCR kits from the STI group, especially with GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit
- Suitable for differential diagnostics of genital ulcer, appearing in the primary stage of syphilis
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 | gene polA encoding DNA polymerase I |
| Analytical Specificity | Treponema pallidum, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.61 cp/μl with the probability of 95 % (on synthetic DNA ultramer Control Treponema pallidum) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | swab from genital ulcer, urine, transport medium: UTM® Viral Transport* (COPAN Diagnostics Inc.) |
| 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 CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System LightCycler ® 480 LineGene 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / Q SLAN® Real-Time PCR System StepOne™ / StepOne Plus™ 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 |
* UTM® Viral Transport is validated only in combination with croBEE NA16 Nucleic Acid Extraction System
** Validated Instrument
