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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 Varicella-Zoster Virus (VZV) MC PCR Kit | VZV/MC/205 | PCR | for 180 quantitative tests |
| 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) | |
| Type of Analysis | Qualitative and quantitative | |
| Automated / Manual detection | Automated | |
| Target sequence | ORF62 gene | |
| Analytical Specificity | Varicella-Zoster virus (VZV), 100 % | |
| Analytical Sensitivity (LoD with 95% Probability) | 155.09 cp/ml | |
| Linear Range | 109 – 102.5 cp/ml with precision of ± 0.5 log | |
| Dynamic Range | 109 – 155.09 cp/ml | |
| Trueness | 0.09 log (CI95%: -0.02 – 0.20) of expected concentration | |
| Precision - repeatability | • Intra-assay SD of log concentration = 0.162 (CI95%: 0.109 – 0.309) |
|
| Precision - reproducibility | • Inter-assay SD of log concentration = 0.224 (CI95%: 0.127 – 1.529) • Inter-device SD of log concentration = 0.201 (CI95%: 0.105 – 1.259) • Total SD of log concentration = 0.198 (CI95%: 0.103 – 1.242) |
|
| Reporting Units | cp/ml | |
| Metrological Traceability | AcroMetrix VZV Plasma Panel | |
| Extraction/Inhibition Control |
myCROBE Universal Internal Control |
|
| Validated Specimen | Plasma, whole blood (EDTA), CSF | |
| Storage | -20 ± 5 °C | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM (VZV), HEX (IC) | |
| External Quality Assessment | Regularly tested in QCMD 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…
