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GeneProof® Varicella-Zoster Virus (VZV) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
EXCELLENT QUALITY
The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (97.37%)
QUALITATIVE AND QUANTITATIVE DETECTION
Quantification of viral load provides additional information for management of VZV infection
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one run
EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary
CONTAMINATION PREVENTION
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination
UNI PCR PROFIL = ONE WORKFLOW
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CERTIFIED DIAGNOSTIC TESTS
VZV/GP/025 - 25 tests
VZV/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | ORF31 gene |
| DIAGNOSTIC SPECIFICITY | 97.37 % (CI95%: 84.57 % – 99.86 %) |
| POSITIVE PREDICTIVE VALUE | 99.48 % (CI95%: 96.72 % – 99.97 %) |
| DYNAMIC RANGE | (10*10 – LoD) cp/ml (LoD varying according to the extraction and material used) |
| CONVERSION FACTOR | Not applicable |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
| STORAGE | (-20 ± 5) °C |
| APPLIED INSTRUMENTS | ▪ croBEE Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ Applied Biosystems 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 Real-Time PCR System ▪ CFX96/ Dx Real-Time PCR Detection System ▪ CFX Opus 96 Real-Time PCR System ▪ Gentier 96E/96R Real-Time PCR 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 ▪ StepOne / StepOne Plus Real-Time PCR System |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| REGULATORY STATUS | CE 2797 IVD / Regulation (EU) 2017/746 |
|---|---|
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | Varicella-Zoster Virus (VZV), 100% |
| DIAGNOSTIC SENSITIVITY | 100.00 % (CI95%: 97.57 % – 100.00 %) |
| NEGATIVE PREDICTIVE VALUE | 100.00 % (CI95%: 88.29 % – 100.00 %) |
| REPORTING UNITS | cp/ml |
| METROLOGICAL TRACEABILITY | AcroMetrix VZV Plasma Panel |
| VALIDATED SPECIMEN | DNA extracted from CSF, plasma, serum, whole blood (EDTA), vesicular swab (qualitative detection only) |
| VALIDATED EXTRACTION METHOD | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ myCROBE/croBEE 2.0 Universal Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| DETECTION CHANNELS | FAM (VZV), HEX/JOE/VIC (IC) |
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 |
