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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISEX/025 | real-time PCR | 25 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISEX/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 large tumor antigen (BKV) and t-Ag gene encoding small tumor antigen (JCV) | ||||||||||||
Analytical Specificity |
BK virus, 100 % |
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Analytical Sensitivity (LoD with 95% probability) |
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Diagnostic Specificity | 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %) | ||||||||||||
Diagnostic Sensitivity | 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %) | ||||||||||||
Positive Predictive Value | 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %) | ||||||||||||
Negative Predictive Value | 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %) | ||||||||||||
Linear Range |
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Dynamic Range | 1010 IU/ml – LoD (LoD varying according to the extraction) | ||||||||||||
Trueness (of expected concentration) |
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Precision – repeatability | • Intra-assay FAM: SD of log concentration = 0.046 (CI95%: 0.037 - 0.061) Cy5: SD of log concentration = 0.046 (CI95%: 0.037 - 0.060) |
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Precision – reproducibility | • Inter-assay FAM: SD of log concentration = 0.044 (CI95%: 0.028 - 0.097) Cy5: SD of log concentration = 0.046 (CI95%: 0.030 - 0.101) • Inter-lot FAM: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116) Cy5: SD of log concentration = 0.055 (CI95%: 0.036 - 0.122) • Total FAM: SD of log concentration = 0.050 (CI95%: 0.032 - 0.111) Cy5: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116) |
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Reporting Units | IU/ml | ||||||||||||
Metrological Traceability |
1st WHO International Standard for BK Virus DNA (NIBSC code 14/212) |
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Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
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Validated Specimen | CSF, plasma, urine, whole blood | ||||||||||||
Storage | -20 ± 5 °C | ||||||||||||
Validated Extraction Method |
croBEE 201A Nucleic Acid Extraction Kit |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels | FAM (JCV), Cy5 (BKV), HEX/JOE/VIC (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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