- Home/
- Products/
- Molecular diagnostics/
- PCR/
- PCR reagent kits/
- GeneProof® JC Virus (JCV) PCR Kit
- NEW
- IVDR
.png "GeneProof® JC Virus (JCV) PCR Kit")
.jpg "GeneProof® JC Virus (JCV) PCR Kit - Picture 2")
.jpg "GeneProof® JC Virus (JCV) PCR Kit - Picture 3")
.jpg "GeneProof® JC Virus (JCV) PCR Kit - Picture 4")
.jpg "GeneProof® JC Virus (JCV) PCR Kit - Picture 5")
GeneProof® JC Virus (JCV) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
W.H.O. STANDARD BASED QUANTIFICATION
Precise and fully traceable quantification according to 1st WHO International Standard NIBSC JCV 14/114
EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one workflow
CONTAMINATION PREVENTION
Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
JCV/GP/025 - 25 tests
JCV/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | t-Ag gene encoding small tumor antigen |
| DIAGNOSTIC SPECIFICITY | 97.50 % (CI95%: 85.27 % – 99.87 %) |
| POSITIVE PREDICTIVE VALUE | 96.43 % (CI95%: 79.76 % – 99.81 %) |
| REPORTING UNITS | IU/ml |
| METROLOGICAL TRACEABILITY | JC Virus (JCV) NIBSC 14/114 (1st WHO International Standard for JC virus DNA) |
| VALIDATED SPECIMEN | DNA extracted from CSF, plasma, urine, whole blood (EDTA) |
| VALIDATED EXTRACTION METHOD | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM (JCV), HEX/JOE/VIC (IC) |
| REGULATORY STATUS | CE 2797 IVD / Regulation (EU) 2017/746 |
|---|---|
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | JC Virus (JCV), 100% |
| DIAGNOSTIC SENSITVITY | 100.00 % (CI95%: 84.5 % – 100.00 %) |
| NEGATIVE PREDICTIVE VALUE | 100.00 % (CI95%: 88.83 % – 100.00 %) |
| CONVERSION FACTOR | 1 IU = 1.3 cp |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
| STORAGE | 20 ± 5 °C |
| INSTRUMENTS | ▪ croBEETM Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ Applied Biosystems 7300 / 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 Real-Time PCR System CFX Connect / CFX96 / Dx Real-Time PCR Detection System ▪ Gentier 96E/96R Real-Time PCR System ▪ LightCycler® 480 ▪ LineGene 9600 Plus ▪ Mic qPCR Cycler ▪ QuantStudio 3 / 5 Real-Time PCR System ▪ Rotor-GeneTM 3000 / Q ▪ SLAN® Real-Time PCR System |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com |
Service and Warranty
GENEPROOF CALCULATOR
The on-line calculator was developed by GeneProof to simplify the evaluation of GeneProof quantitative PCR kits.
To access the online calculator, click the button below
If you have any questions, please contact our specialists on the CONTACTS page.
We provide premium service and maintenance for every device and consumable:
• Comprehensive maintenance of medical equipment
• Installations, commissioning
• Warranty and post-warranty service
• Instruction, training and consultations for your team
More details on the SERVICE page
| Contact phone | +38 (067) 133 05 52 |
|---|---|
| E-mail: | service@empirica.healthcare |