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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 Cytomegalovirus (CMV) MC PCR Kit | CMV/MC/205 | PCR | for 180 quantitative tests |
| Indication | in vitro diagnostic medical device | |
| Regulatory Status | CE1023IVD / 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 | 4 IE antigen gene | |
| Analytical Specificity | Human Cytomegalovirus, 100 % | |
| Analytical Sensitivity (LoD with 95% Probability) | 297.27 IU/ml | |
| Linear Range | 109 – 103 IU/ml with precision of ± 0.5 log | |
| Dynamic Range | 109 – 297.27 IU/ml | |
| Trueness | 0.10 log (CI95%: 0.02– 0.19) of expected concentration | |
| Precision - repeatability | • Intra-assay SD of log concentration = 0.151 (CI95%: 0.102 – 0.290) |
|
| Precision - reproducibility | • Inter-assay SD of log concentration = 0.229 (CI95%: 0.119 – 1.433) • Inter-device SD of log concentration = 0.183 (CI95%: 0.096 – 1.149) • Total SD of log concentration = 0.248 (CI95%: 0.129 – 1.552) |
|
| Reporting Units | IU/ml and cp/ml | |
| Metrological Traceability | CMV NIBSC 09/162 (1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques) | |
| Extraction/Inhibition Control |
myCROBE Universal Internal Control |
|
| Validated Specimen | Plasma, whole blood (EDTA) | |
| Storage | -20 ± 5 °C | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM (CMV), HEX (Internal control) | |
| 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…
