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GeneProof Team
On this page you will find order codes, technical specifications and documents for the selected product.
Product name | Catalog no. | Technology | Packaging |
GeneProof MTHFR C677T MC PCR Kit | M677/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 | C677T polymorphismin the gene of methylenetetrahydrofolate reductase (MTHFR), (rs1801133) | |
Specificity | Single nucleotide cytosine/thymine polymorphism in the gene of MTHFR in site 677 (C677T) (rs1801133) | |
Concentration Range | 10-90 ng/µl | |
Negative Percentage Agreement | 96.72 % (CI95%: 87.64 % - 99.43 %) | |
Positive Percentage Agreement | 96.77 % (CI95%: 87.83 % - 99.44 %) | |
Overall Percentage Agreement | 96.75 % (CI95%: 91.38 % - 98.95 %) | |
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…