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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 |
| 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 with 95% Probability ) |
Performed on EBV NIBSC 09/260 |
manual extraction GeneProof PathogenFree DNA Isolation Kit |
automatic extraction croBEE 201A Nucleic Acid Extraction Kit |
| Plasma | 196.1 IU/ml | 289.5 IU/ml | |
| Whole blood | 129.2 IU/ml | 250.2 IU/ml | |
| CSF | 110.8 IU/ml | 586.1 IU/ml | |
| Diagnostic Specificity | 94.19 % (CI95%: 86.35 % - 97.84 %) | ||
| Diagnostic Sensitivity | 99.10 % (CI95%: 96.45 % - 99.84 %) | ||
| Positive Predictive Value | 97.79 % (CI95%: 94.63 % - 99.18 %) | ||
| Negative Predictive Value | 94.59 % (CI95%: 90.76 % - 99.58 %) | ||
| Linear Range |
1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit) |
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| Dynamic Range | 1010 – 196.1 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 289.5 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
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| Trueness | -0.07 log (CI95%: -0.13 – 0.00) of expected concentration using manual extraction GeneProof PathogenFree DNA Isolation Kit -0.08 log (CI95%: -0.13 – 0.03) of expected concentration using automatic extraction croBEE 201A Nucleic Acid Extraction Kit |
||
| Precision - Repeatability | Intra-assay SD of log concentration = 0.084 (CI95%: 0.068 – 0.110) | ||
| 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) |
| Reporting Units |
IU/μl |
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| Conversion Factor |
1 IU = 1 cp |
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| Metrological Traceability |
EBV NIBSC 09/260 (1st WHO International Standard for Epstein-Barr Virus for Nucleic Acid Amplification |
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| Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control |
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| Validated Specimen | BAL**, CSF, plasma, whole blood* | ||
| Storage | -20 ± 5 °C | ||
| Validated Extraction Method | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
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| Instruments |
croBEE Real-Time PCR System |
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| 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 | ||
| Certification | CE IVD | ||
* EBV persists latently in memory B-cell at low viral level. Therefore, even healthy individuals can carry measurable EBV load in their peripheral blood.
** Due to the possible inhomogeneity in the BAL collection, the product is intended only for qualitative determination from this material.
+420 543 211 679
sales@geneproof.com
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+420 730 176 222
support@geneproof.com
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