.png "GeneProof® Epstein-Barr Virus (EBV) PCR Kit")
.jpg "GeneProof® Epstein-Barr Virus (EBV) PCR Kit - Picture 2")
.jpg "GeneProof® Epstein-Barr Virus (EBV) PCR Kit - Picture 3")
.jpg "GeneProof® Epstein-Barr Virus (EBV) PCR Kit - Picture 4")
- Home/
- Products/
- Molecular diagnostics/
- PCR/
- PCR reagent kits/
- GeneProof® Epstein-Barr Virus (EBV) PCR Kit
- TOP
- IVDR
GeneProof® Epstein-Barr Virus (EBV) 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 WHO 1st International Standard NIBSC 09/260
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits 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
CONTAMINATION PREVENTION
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
EBV/ISEX/025 – 25 tests
EBV/ISEX/100 – 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| INTENDED USER | For professional use in laboratories with trained staff |
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | Epstein-Barr virus, 100 % |
| DIAGNOSTIC SENSITIVITY | 99.10 % (CI95% : 96.45 % – 99.84 %) |
| NEGATIVE PREDICTIVE VALUE | 94.59 % (CI95% : 90.76 % – 99.58 %) |
| TRUENESS | -0.07 log (CI95% : -0.13 – 0.00) using manual extraction GeneProof PathogenFree DNA Isolation Kit; -0.08 log (CI95% : -0.13 – 0.03) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit |
| PRECISION – REPRODUCIBILITY | Inter-assay SD of log concentration = 0.092 (CI95% : 0.059 – 0.202); Inter-lot SD of log concentration = 0.112 (CI95% : 0.072 – 0.246); Total SD of log concentration = 0.115 (CI95% : 0.074 – 0.254) |
| CONVERSION FACTOR | 1 IU = 1 cp |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
| STORAGE | -20 ± 5 °C |
| INSTRUMENTS | croBEE 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® 2.0 / 480 LineGene 9600 / 9600 Plus; Mic qPCR Cycler; Montania 4896 Real-Time PCR termocykler; QuantStudio™ 3 / 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 IVD |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | Gen EBNA1 |
| DIAGNOSTIC SPECIFICITY | 94.19 % (CI95% : 86.35 % – 97.84 %) |
| POSITIVE PREDICTIVE VALUE | 97.79 % (CI95% : 94.63 % – 99.18 %) |
| DYNAMIC RANGE | 10*10 – LoD cp/ml (LoD varying according to the extraction method and material used) |
| PRECISION – REPEATABILITY | Intra-assay SD of log concentration = 0.084 (CI95% : 0.068 – 0.110) |
| REPORTING UNITS | cp/ml |
| METROLOGICAL TRACEABILITY | 1st WHO International Standard for Epstein-Barr Virus, code: EBV NIBSC 09/260 |
| VALIDATED SPECIMEN | CSF, plasma, whole blood (EDTA), BAL |
| VALIDATED EXTRACTION METHOD | croBEE 201A Nucleic Acid Extraction Kit; GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM (EBV), HEX/JOE/VIC (IS) |
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
Contacts for communication:
| Contact phone | +38 (067) 120 95 75 |
|---|---|
| E-mail: | service@empirica.healthcare |