Leírás
PRODUCT ADVANTAGES
PART OF I/T PANEL
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted Panel in one workflow
- Simplifies laboratory 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
W.H.O. STANDARD BASED QUANTIFICATION
- Precise and fully traceable quantification according to WHO 1st International Standard NIBSC 09/260
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 | DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) | |
| Analytical Specificity | Epstein-Barr virus, 100 % | |
| Analytical Sensitivity (LoD) | reaches up to 196.088 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 289.46 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
|
| Diagnostic Specificity | 100 % (CI95 % : 83.98 % – 100 %) according to EQA panels results 90.91 % (CI95 % : 79.29 % – 96.60 %) according to Clinical performance analysis 2019 |
|
| Diagnostic Sensitivity | 100 % (CI95 % : 96.53 % – 100 %) according to EQA panels results 98.08 % (CI95 % : 88.42 % – 99.90 %) according to Clinical performance analysis 2019 |
|
| Linear Range | 1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 102.5 IU/ml with precision of ± 0.5 log (using automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
|
| Dynamic Range | 1010 – 196.088 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 289.46 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
|
| Reporting Units | cp/μl | |
| Conversion Factor | 1 IU = 1 cp | |
| Metrological Traceability | EBV NIBSC 09/260 | |
| Extraction / Inhibition Control | PCR inhibition and DNA extraction efficiency control (ISEX version) | |
| Validated Specimen | CSF, plasma, whole blood, BAL | |
| Storage | -20 ± 5 °C | |
| Validated Extraction Method | croBEE 201A Nucleic Acid Extraction Kit 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 QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000 / Q SLAN® Real-Time PCR System Montania 4896 Real-Time PCR termocykler StepOne™ / StepOnePlus™ 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 | |
| Regulatory Status | CE IVD | |
