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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Factor II Prothrombin PCR Kit | FII/025 | real-time PCR | 25 reactions |
GeneProof Factor II Prothrombin PCR Kit | FII/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Technology | Real-time PCR |
Type of Analysis | Qualitative |
Target Sequence | G20210A polymorphism in F2 gene for Factor II Prothrombin (rs1799963) |
Analytical Sensitivity (LoD) | reaches up to 2 ng/μl |
Negative Percentage Agreement | 100 % (CI95%: 93.05 % - 100 %) |
Positive Percentage Agreement | 100 % (CI95%: 82.83 % - 100 %) |
Overall Percentage Agreement | 100 % (CI95%: 94.84 % - 100 %) |
Validated Specimen | whole blood |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX/JOE/VIC |
External Quality Assessment | Regularly tested in 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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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…