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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 | ||||||||
Regulatory Status | CE IVD / EC Directive 98/79/EC | ||||||||
Intended User | For professional use in laboratories with trained staff | ||||||||
Test Principle | Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection | ||||||||
Type of analysis |
Qualitative and quantitative |
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Target Sequence |
Gen EBNA1 |
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Analytical Specificity |
Epstein-Barr virus, 100 % |
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Analytical Sensitivity (LoD with 95% probability) |
Sample Processing |
Plasma | Whole blood | CSF | BAL | ||||
GeneProof PathogenFree DNA Isolation Kit | 196.1 IU/ml | 129.2 IU/ml | 110.8 IU/ml | 206.0 IU/ml | |||||
croBEE 201A Nucleic Acid Extraction Kit | 289.5 IU/ml | 250.2 IU/ml | 586.1 IU/ml | 138.1 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 |
Extraction method |
Precision | Plasma | Whole blood | BAL | Precision | CSF | ||
GeneProof PathogenFree DNA Isolation Kit | ± 0,5 log | 1010 – 102.5 IU/ml | 1010 – 102.5 IU/ml | 1010 – 102.5 IU/ml | ± 0,6 log | 1010 – 102.5 IU/ml | |||
croBEE 201A Nucleic Acid Extraction Kit | 1010 – 103 IU/ml | 1010 – 103 IU/ml | 1010 – 103 IU/ml | ||||||
Dynamic Range | 1010 – LoD IU/ml (LoD varying according to the extraction method and material used) | ||||||||
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 |
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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) |
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Reporting Units |
cp/ml |
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Conversion Factor |
1 IU = 1 cp |
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Metrological Traceability |
1st WHO International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques, code: EBV NIBSC 09/260 |
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Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
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Validated Specimen | CSF, plasma, whole blood (EDTA), BAL | ||||||||
Storage Conditions | -20 ± 5 °C | ||||||||
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
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Applied Instruments |
croBEE Real-Time PCR System |
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Detection Channels | FAM (EBV), HEX/JOE/VIC (IS) | ||||||||
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels -results at www.geneproof.com |
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…