Genvinset® HFE Multiplex – Real-Time PCR Kit for H63D & C282Y Detection
Catalog Number: GVS-HFE-M-24
Genvinset® HFE Multiplex is a CE-IVDR Real-Time PCR kit for simultaneous qualitative detection and genotyping of the HFE H63D (rs1799945) and C282Y (rs1800562) mutations in genomic DNA extracted from whole blood. Using multiplex TaqMan® hydrolysis-probe technology, the assay supports molecular genetic assessment associated with hereditary hemochromatosis.
The assay differentiates wild-type, heterozygous and homozygous mutant genotypes for both H63D and C282Y within the same multiplex PCR workflow. H63D alleles are detected through FAM and HEX/VIC channels, while C282Y alleles are detected through ROX and Cy5 channels. The kit includes wild-type and mutant controls together with a Reaction Blank.
The IFU specifies HEX for H63D wild-type, FAM for H63D mutant, Cy5 for C282Y wild-type and ROX for C282Y mutant
Method: Multiplex Real-Time PCR with TaqMan® hydrolysis probes
| Intended Use | Genvinset® HFE multiplex is a semi-automated in vitro diagnostic kit intended for the qualitative detection of the C282Y mutation (NCBI dbSNP rs1800562; NM_000410.4:c.845G>A) and H63D mutation (NCBI dbSNP rs1799945; NM_000410.4:c.187C>G) in the HFE gene (OMIM: 613609), associated with hereditary hemochromatosis, in genomic DNA extracted from whole blood. The assay uses Real-Time PCR technology with specific TaqMan® probes. Results should be used as an aid in diagnosis 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 (EU) 2017/746 | ||||||||||||||||||||||||
| 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 HFE H63D and C282Y 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 | Hereditary hemochromatosis; HFE gene; H63D; C282Y; rs1799945; rs1800562; iron metabolism; genetic testing; molecular diagnostics | ||||||||||||||||||||||||
| Other names | HFE Multiplex PCR Kit; H63D C282Y PCR Kit; HFE H63D/C282Y Test; Hemochromatosis Genotyping Kit; HFE Mutation Detection Kit; H63D and C282Y Genotyping Test | ||||||||||||||||||||||||
| Intra-assay (Within-Run) | 100% repeatability in manufacturer validation | ||||||||||||||||||||||||
| Limit of Detection | 1.48 ng DNA, Ct <35 | ||||||||||||||||||||||||
| Product Number | GVS-HFE-M-24 | ||||||||||||||||||||||||
| Manufacturer | BLACKHILS DIAGNOSTIC RESOURCES | ||||||||||||||||||||||||
| Certification | CE IVD | ||||||||||||||||||||||||
| Order | Request Quote |
