GeneProof Borrelia burgdorferi PCR Kit
Kat.: BB/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Minden, a világszerte előforduló, Borrelia burgdorferi sensu lato törzs tagjainak detektálására alkalmas, ‘Ready-To-Use’ master mix. A 16S rRNS gén szekvencia multikópiáit célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of the 16S rRNA gene
WIDE RANGE OF VALIDATED CLINICAL MATERIALS
- Validated specimen: plasma, serum, whole blood, CSF, urine and tick
HIGH SPECIFICITY
- Detection of all Borrelia burgdorferi sensu lato strains worldwide
- B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi,B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii
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 gene sequence encoding 16S rRNA |
| Specificity | B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, 100 % |
| Sensitivity (LoD) | reaches up to 0.568 cp/μl with the probability of 95 % (on Amplirun® Borrelia burgdorferi DNA control, Vircell) |
| Extraction / Inhibition Control | PCR Inhibition and DNA extraction efficiency control |
| Validated Specimen | CSF, plasma, serum, tick, urine, whole blood |
| 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 |
| 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 |
*Validated instruments
