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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof JC Virus (JCV) PCR Kit | JCV/GP/025 | real-time PCR | 25 reactions |
GeneProof JC Virus (JCV) PCR Kit | JCV/GP/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device | |||||||||||||||
Regulatory Status | CE IVD | |||||||||||||||
Intended User | For professional use in laboratories with trained staff | |||||||||||||||
Technology | real-time PCR | |||||||||||||||
Type of Analysis | qualitative and quantitative | |||||||||||||||
Target Sequence | t-Ag gene encoding small tumor antigen | |||||||||||||||
Analytical Specificity | JC Virus (JCV), 100 % | |||||||||||||||
Analytical Sensitivity (LoD with 95% probability) |
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Diagnosis Specificity |
97.50 % (CI95%: 85.27 % - 99.87 %) |
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Diagnosis Sensitivity | 100.00 % (CI95%: 84.5 % - 100.00 %) | |||||||||||||||
Positive Predictive Value | 96.43 % (CI95%: 79.76 % - 99.81 %) | |||||||||||||||
Negative Predictive Value | 100.00 % (CI95%: 88.83 % - 100.00 %) | |||||||||||||||
Linear Range |
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Dynamic Range | 1010 – LoD IU/ml (LoD varying according to the extraction and material used) | |||||||||||||||
Trueness (of expected concentration) |
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Precision – Repeatability | Intra-assay SD of log concentration = 0.068 (CI95%: 0.055 – 0.089) | |||||||||||||||
Precision – Reproducibility | Inter-assay SD of log concentration = 0.078 (CI95%: 0.050 – 0.171) Inter-lot SD of log concentration = 0.094 (CI95%: 0.061 – 0.208) Total SD of log concentration = 0.086 (CI95%: 0.055 – 0.190) |
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Reporting Units | IU/ml | |||||||||||||||
Metrological Traceability | 1st WHO International Standard for JC virus DNA (NIBSC code 14/114) | |||||||||||||||
Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Control |
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Validated Specimen | CSF, plasma, urine, whole blood | |||||||||||||||
Storage | -20 ± 5 °C | |||||||||||||||
Validated Extraction Methods |
croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
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Validated Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels | FAM (JCV), HEX/JOE (IC) | |||||||||||||||
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…