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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof MTHFR A1298C PCR Kit | M1298/025 | real-time PCR | 25 reactions |
GeneProof MTHFR A1298C PCR Kit | M1298/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
Regulatory Status | CE IVD |
Technology | Real-time PCR |
Type of Analysis | Qualitative |
Target Sequence | A1298C polymorphism in the gene of methylenetetrahydrofolate reductase (MTHFR) |
Analytical Sensitivity (LoD) | Reaches up to 2 ng/µl |
Positive Percentage Agreement | 100 % (CI95%: 78.12 % - 100 %) |
Negative Percentage Agreement | 100 % (CI95%: 69.87 % - 100 %) |
Overall Percentage Agreement | 100 % (CI95%: 85.87 % - 100 %) |
Validated Specimen | whole blood |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX/JOE |
External Quality Assessment | Tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
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