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GeneProof Team
myCROBE® line
On this page you will find order codes, technical specifications and documents for the selected product.
| Product name | Catalog no. | Technology | Packaging |
| GeneProof JC Virus (JCV) MC PCR Kit | JCV/MC/205 | PCR | for 180 quantitative tests |
| Indication | in vitro diagnostic medical device | |
| Regulatory Status | CE IVD | |
| Intended User | For professional use in laboratories with trained staff | |
| Test Principle | Real-time polymerase chain reaction (PCR) | |
| Type of Analysis | Qualitative and quantitative | |
| Automated / Manual detection | Automated | |
| Target sequence | Gen T-Ag gene | |
| Analytical Specificity | JC virus (JCV), 100 % | |
| Analytical Sensitivity (LoD with 95% Probability) | 12.85 IU/ml | |
| Linear Range | 109 – 102 IU/ml with precision of ± 0.5 log | |
| Dynamic Range | 109 –12.85 IU/ml | |
| Trueness | 0.01 log (CI95%: -0.05 – 0.08) of expected concentration | |
| Precision - repeatability | • Intra-assay SD of log concentration = 0.100 (CI95%: 0.068 – 0.192) |
|
| Precision - reproducibility | • Inter-assay SD of log concentration = 0.152 (CI95%: 0.079 – 0.950) • Inter-device SD of log concentration = 0.150 (CI95%: 0.078 – 0.936) • Total SD of log concentration = 0.155 (CI95%: 0.081 – 0.972) |
|
| Reporting Units | IU/ml and cp/ml | |
| Conversion Factor | 1 IU = 1 cp | |
| Metrological Traceability | JC Virus NIBSC 14/114 (1st WHO International Standard for JC Virus DNA) | |
| Extraction/Inhibition Control |
myCROBE Universal Internal Control |
|
| Validated Specimen | Plasma, whole blood (EDTA), urine, CSF | |
| Storage | -20 ± 5 °C | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM (JCV), HEX (IC) | |
| External Quality Assessment | Regularly tested in 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…
