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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Epstein-Barr Virus (EBV) PCR Kit | EBV/ISEX/100 | real-time PCR | 100 reactions |
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) |
|
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) |
|
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 |
|
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 |
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