GeneProof Epstein-Barr Virus (EBV) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for detection of Epstein-Barr virus (EBV) by the real-time Polymerase Chain Reaction (PCR) method.
The EBV detection consists in amplification of a specific conservative DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) and in measurement of fluorescence increase. The EBV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.
TECHNICAL SPECIFICATION
| 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) |
| Linear Range | 1010 – 102.5 IU/ml with precision of ± 0.5 log |
| Reporting Units | cp/μl |
| Conversion Factor | 1 IU = 1 cp |
| Metrological Traceability | NIBSC EBV 09/260 |
| Extraction / Inhibition Control | PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | CSF, plasma, whole blood, BAL |
| 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 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 |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results an www.geneproof.com |
| Regulatory Status | CE IVD for in vitro Diagnostics Use |
* Validated Instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISIN/025 | real-time PCR | 25 reactions |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISIN/050 | real-time PCR | 50 reactions |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISIN/100 | real-time PCR | 100 reactions |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISEX/100 | real-time PCR | 100 reactions |