Genvinset® FIIFV Multiplex – Real-Time PCR Kit for Factor II G20210A & Factor V Leiden G1691A Detection
Catalog Number: GVS-FIIFV-24
Genvinset® FIIFV Multiplex is a CE-IVDR Real-Time PCR kit for simultaneous qualitative detection and genotyping of Prothrombin/Factor II G20210A (rs1799963) and Factor V Leiden G1691A (rs6025) mutations in genomic DNA extracted from whole blood. Using multiplex TaqMan® hydrolysis-probe technology, the assay supports molecular genetic assessment of two clinically relevant variants associated with thrombophilia risk.
The assay differentiates homozygous wild-type, heterozygous and homozygous mutant genotypes for both Factor II and Factor V within a single PCR workflow. Factor V alleles are detected through HEX/VIC and FAM channels, while Factor II alleles are detected through Cy5 and ROX channels. The kit includes wild-type and mutant controls together with a Reaction Blank.
Method: Multiplex Real-Time PCR with TaqMan® hydrolysis probes
| Intended Use | Genvinset® FIIFV multiplex is a semi-automated in vitro diagnostic kit intended for the qualitative detection of the G20210A mutation (NCBI dbSNP rs1799963; NM_000506.5:c.97G>A) in the prothrombin (Factor II/FII) gene and the G1691A mutation (NCBI dbSNP rs6025; NM_000130.5:c.1601G>A) in the Factor V (FV/F5) gene, associated with thrombophilia risk, in genomic DNA extracted from whole blood. The assay uses multiplex Real-Time PCR technology with specific TaqMan® probes. Results should be interpreted together with clinical findings and other relevant disease markers and should not be used as the sole basis for therapeutic decisions. | ||||||||||||||||||||||||
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| Size | 24 Tests / kit | ||||||||||||||||||||||||
| Shelf life | Until expiry date indicated on product label | ||||||||||||||||||||||||
| Certification | CE-IVD / IVDR | ||||||||||||||||||||||||
| Company | bioactiva diagnostica GmbH | ||||||||||||||||||||||||
| Storage condition | −30°C to −18°C | ||||||||||||||||||||||||
| Summary | CE-IVDR multiplex Real-Time PCR kit for simultaneous qualitative detection and genotyping of Factor II G20210A and Factor V Leiden G1691A mutations from human whole-blood genomic DNA. | ||||||||||||||||||||||||
| Materials Provided |
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| Inter-assay (Run-to-Run) | 100% reproducibility in manufacturer validation | ||||||||||||||||||||||||
| Research topic | Thrombophilia; Factor V Leiden; Factor V; F5 gene; Factor II; prothrombin; F2 gene; G1691A; G20210A; rs6025; rs1799963; venous thromboembolism; coagulation genetics; molecular diagnostics | ||||||||||||||||||||||||
| Other names | Factor II / Factor V Multiplex PCR Kit; FII/FV Thrombophilia Test; Prothrombin G20210A and Factor V Leiden Test; G20210A G1691A Genotyping Kit; Factor II and Factor V Mutation Detection Kit; FIIFV Multiplex Test | ||||||||||||||||||||||||
| Intra-assay (Within-Run) | 100% repeatability in manufacturer validation | ||||||||||||||||||||||||
| Limit of Detection | 1.48 ng DNA, Ct <35 | ||||||||||||||||||||||||
| Product Number | GVS-FIIFV-24 | ||||||||||||||||||||||||
| Manufacturer | BLACKHILS DIAGNOSTIC RESOURCES | ||||||||||||||||||||||||
| Certification | CE IVD | ||||||||||||||||||||||||
| Order | Request Quote |
