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|Product name||Catalog no.||Technology||Packaging|
|GeneProof MTHFR C677T PCR Kit||M677/025||real-time PCR||25 reactions|
|GeneProof MTHFR C677T PCR Kit||M677/100||real-time PCR||100 reactions|
|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|
|Type of Analysis||qualitative|
|Target Sequence||C677T mutation in the gene for 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 Kit
GeneProof PathogenFree DNA Isolation Kit
croBEE Real-Time PCR System
|Required Detection Channels||FAM, HEX|
|External Quality Assessment||Tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com|
* In Rotor-Gene instruments leave all available detection channels on.
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