Genvinset® MTHFR Multiplex – Real-Time PCR Kit for A1298C & C677T Detection

In stock
SKU/Catalog Number
GVS-MTH-M-24

Catalog Number: GVS-MTH-M-24

Genvinset® MTHFR Multiplex is a CE-IVDR Real-Time PCR kit for simultaneous qualitative detection and genotyping of the MTHFR A1298C (rs1801131) and C677T (rs1801133) polymorphisms in genomic DNA extracted from whole blood. Using multiplex TaqMan® hydrolysis-probe technology, the assay enables both MTHFR variants to be analysed within a single PCR workflow.

The assay distinguishes homozygous wild-type, heterozygous and homozygous variant genotypes for both polymorphisms. MTHFR A1298C alleles are detected through HEX and FAM channels, while MTHFR C677T 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

More Information
Intended UseGenvinset® MTHFR multiplex is a semi-automated in vitro diagnostic kit intended for the qualitative detection of the A1298C polymorphism (NCBI dbSNP rs1801131; NM_001330358.2:c.1409A>C) and the C677T polymorphism (NCBI dbSNP rs1801133; NM_001330358.2:c.788C>T) in the methylenetetrahydrofolate reductase (MTHFR) gene (OMIM: 607093), in genomic DNA extracted from whole blood. The assay uses multiplex Real-Time PCR technology with specific TaqMan® probes. In the intended clinical context described by the manufacturer, women with idiopathic recurrent pregnancy loss may be referred for determination of these MTHFR polymorphisms. Results should be used as an aid in diagnosis together with clinical findings and other relevant markers and should not be used as the sole basis for therapeutic decisions.
Size24 Tests/ Kit
Shelf lifeUntil expiry date indicated on product label
CertificationCE-IVD / IVDR
Companybioactiva diagnostica GmbH
Storage condition−30°C to −18°C
SummaryCE-IVDR multiplex Real-Time PCR kit for simultaneous qualitative detection and genotyping of MTHFR A1298C (rs1801131) and C677T (rs1801133) polymorphisms from human whole-blood genomic DNA.
Materials Provided
Component Reference 24-test kit 48-test kit
Primer Mix GVS-MTH-M-PM / PML 1 × 192 µL 2 × 192 µL
Master Mix GVS-MTH-M-MM / MML 1 × 240 µL 2 × 240 µL
Control WT GVS-MTH-M-C1 / C1L 1 × 15 µL 1 × 15 µL
Control MUT GVS-MTH-M-C2 / C2L 1 × 15 µL 1 × 15 µL
Reaction Blank GVS-RB 1 × 100 µL 1 × 100 µL
Inter-assay (Run-to-Run)100% reproducibility in manufacturer validation
Research topic

MTHFR; methylenetetrahydrofolate reductase; A1298C; C677T; rs1801131; rs1801133; folate metabolism; homocysteine metabolism; hyperhomocysteinemia; recurrent pregnancy loss; genetic testing; molecular diagnostics

Other names

MTHFR A1298C/C677T Multiplex PCR Kit; MTHFR A1298C and C677T Test; MTHFR Dual Polymorphism Test; MTHFR Genotyping Kit; rs1801131 rs1801133 Detection Kit; MTHFR Multiplex Test

Intra-assay (Within-Run)100% repeatability in manufacturer validation
Limit of Detection4.44 ng DNA, Ct <35
SpeciesHuman
Product NumberGVS-MTH-M-24
ManufacturerBLACKHILS DIAGNOSTIC RESOURCES
CertificationCE IVD
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