Genvinset® Factor V G1691A – Real-Time PCR Kit for Factor V Leiden Detection
Katalognummer: GVS-FV-48
Genvinset® Factor V G1691A is a CE-IVD Real-Time PCR kit for qualitative detection and genotyping of the Factor V Leiden G1691A mutation (rs6025; c.1601G>A) in genomic DNA extracted from whole blood. Using allele-specific TaqMan® hydrolysis probes, the assay supports molecular genetic assessment of Factor V Leiden associated with thrombophilia risk.
The assay differentiates homozygous wild-type (1691G/G), heterozygous (1691G/A) and homozygous mutant (1691A/A) genotypes. The wild-type allele is detected through the HEX/VIC channel and the mutant allele through the FAM channel. The kit includes wild-type and mutant controls together with a Reaction Blank and is available in 24-, 48- and 96-test formats.
The assay principle specifies HEX for the wild-type 1691G allele and FAM for the mutant 1691A allele, with distinct patterns for the three possible genotype categories.
Method: Real-Time PCR with TaqMan® hydrolysis probes
| Intended Use | Genvinset® Factor V G1691A is a semi-automated in vitro diagnostic kit intended for the qualitative detection of the G1691A mutation (NCBI dbSNP rs6025; NM_000130.5:c.1601G>A) in the Factor V (F5) gene (OMIM: 612309), associated with thrombophilia risk, in genomic DNA extracted from whole blood. The assay uses 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 | 48 Tests / kit | ||||||||||||||||||
| Lagerfähigkeit | Until expiry date indicated on product label | ||||||||||||||||||
| Certification | CE IVD | ||||||||||||||||||
| Company | bioactiva diagnostica GmbH | ||||||||||||||||||
| Storage condition | −30°C to −18°C | ||||||||||||||||||
| Summary | CE-IVD Real-Time PCR kit for qualitative detection and genotyping of the Factor V Leiden G1691A mutation (rs6025) 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; G1691A; rs6025; venous thromboembolism; coagulation genetics; molecular diagnostics | ||||||||||||||||||
| Other names | Factor V Leiden PCR Kit; Factor V G1691A Test; F5 G1691A Genotyping Kit; FV Leiden Mutation Test; rs6025 Detection Kit; Factor V 1691G>A Test; Thrombophilia Factor V Test | ||||||||||||||||||
| Intra-assay (Within-Run) | 100% repeatability in manufacturer validation | ||||||||||||||||||
| Limit of Detection | 0.20 ng/µL, Ct <35 | ||||||||||||||||||
| Product Number | GVS-FV-48 | ||||||||||||||||||
| Hersteller | BLACKHILS DIAGNOSTIC RESOURCES | ||||||||||||||||||
| Zertifizierung | CE IVD | ||||||||||||||||||
| Order | Request Quote |
