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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof BK Virus (BKV) PCR Kit | BKV/GP/025 | real-time PCR | 25 reaction |
GeneProof BK Virus (BKV) PCR Kit | BKV/GP/100 | real-time PCR | 100 reaction |
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 large tumor antigen | ||||||||||||
Analytical Specificity | BK virus (BKV), 100 % | ||||||||||||
Analytical Sensitivity (LoD with 95% probability) |
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Diagnosis Specificity |
100.00 % (CI95%: 86.27 % – 100.00 %) |
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Diagnosis Sensitivity | 96.30 % (CI95%: 79.11 % – 99.81 %) | ||||||||||||
Positive Predictive Value | 100.00 % (CI95%: 83.98 % – 100.00 %) | ||||||||||||
Negative Predictive Value | 96.88 % (CI95%: 82.00 % – 99.84 %) | ||||||||||||
Linear Range | 1010 – 103 IU/ml with precision of ± 0.5 log (using manual or automatic extraction from plasma, CSF and whole blood) |
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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 = 0.061 (CI95%: 0.050 – 0.080) | ||||||||||||
Precision – Reproducibility | Inter-assay SD of log concentration = 0.112 (CI95%: 0.072 – 0.246) Inter-lot SD of log concentration = 0.206 (CI95%: 0.133 – 0.454) Total SD of log concentration = 0.243 (CI95%: 0.157 – 0.536) |
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Reporting Units | IU/ml | ||||||||||||
Conversion Factor | 1 IU = 1 cp | ||||||||||||
Metrological Traceability | 1st WHO International Standard for BK virus DNA (NIBSC code 14/212) | ||||||||||||
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, HEX/JOE | ||||||||||||
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
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