Leírás
PRODUCT ADVANTAGES
MORE INFORMATION FROM ONE REACTION
- Detects and distinguishes BK virus and JC virus in a single reaction tube
- Enables qualitative and quantitative detection of both viruses
CONTAMINATION PREVENTION
- Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
SIMPLE LABORATORY WORKFLOW
- Easily combinable with other PCR kits from Immunocompromised / Transplanted Panel in one workflow
EASY-TO-USE CONCEPT
- Single tube Ready-to-Use Master Mix contains all components for PCR amplification
- No additional PCR reagents pipetting necessary
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 and quantitative |
| Target Sequence | the specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins |
| Analytical Specificity | BK virus, 100 % JC virus, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.684 cp/μl with the probability of 95 % |
| Linear Range | 1010 – 102 cp/ml with precision of ± 0.5 log |
| Reporting Units | cp/μl |
| Metrological Traceability | BKV Molecular ‚Q‘ Panel (Qnostics BKV) JCV Molecular ‚Q‘ Panel (Qnostics JCV) |
| Extraction / Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | CSF, plasma, urine, whole blood |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX96™ / Dx Real-Time PCR Detection System LightCycler® 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com |
| Regulatory Status | CE IVD |
