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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 Factor XIII V34L MC PCR Kit | FXIII/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 | G103T Polymorphism in the F13A1 gene of Factor XIII (V34L) (rs5985) | |
Specificity | Single nucleotide guanine/thymine polymorphism in the F13A1 gene of Factor XIII (V34L) at site 103 (rs5985)) | |
Concentration Range | 10-90 ng/µl | |
Negative Percentage Agreement | 100 % (CI95%: 93,05 % - 100 %) | |
Positive Percentage Agreement | 100 % (CI95%: 89,79 % - 100 %) | |
Overall Percentage Agreement | 100 % (CI95%: 95,72 % - 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 | Tested in Reference Institute for Bioanalytics 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…