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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 A1298C MC PCR Kit | M1298/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 | A1298C polymorphism in the gene for methylenetetrahydrofolate reductase (MTHFR) (rs1801131) | |
Specificity | Single nucleotide adenine/cytosine polymorphism in the MTHFR gene at site 1298 (A1298C) (rs1801131) | |
Concentration Range | 10-90 ng/µl | |
Negative Percentage Agreement | 98.04 % (CI95%: 88.21 % - 99.90 %) | |
Positive Percentage Agreement | 100 % (CI95%: 93.69 % - 100 %) | |
Overall Percentage Agreement | 99.19 % (CI95%: 94.89 % - 99.96 %) | |
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…