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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 Factor V Leiden MC PCR Kit | FV/MC/200 | PCR | for 180 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 | |
| Automated / Manual detection | Automated | |
| Target | G1691A Polymorphism in the F5 gene of Factor V Leiden (rs6025) | |
| Specificity | Single nucleotide guanine/adenine polymorphism in the F5 gene of Factor V Leiden in site 1691 (rs6025) | |
| Concentration Range | 10-90 ng/µl | |
| Negative Percentage Agreement | 100% (CI95%: 97.04% - 100%) | |
| Positive Percentage Agreement | 100% (CI95%: 79.08% - 100%) | |
| Overall Percentage Agreement | 100% (CI95%: 97.35% - 100%) | |
| Validated Specimen | Whole blood | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM, HEX | |
| 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…
