CVD StripAssay T
The Viennalab CVD StripAssay T identifies nine variants in six genes associated with an increased risk of thrombosis and cardiovascular disease: Factor V G1691A (Leiden) and H1299R (R2), prothrombin G20210A, MTHFR C677T and A1298C, Factor XIII V34L, PAI-1 4G/5G, and EPCR A4600G and G4678C. The kit works from fresh or frozen EDTA or citrate blood and contains the lysis solution and resin for releasing DNA. Taq DNA Polymerase is not supplied and has to be ordered separately.
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This kit in detail
- Nine variants in six genes: F5, prothrombin, MTHFR, F13, PAI-1 and EPCR
- Factor V Leiden and R2, prothrombin G20210A, MTHFR C677T and A1298C
- Reverse hybridisation on a test strip, read by eye
- Lysis solution and GENxTRACT resin included for whole blood
- Taq DNA Polymerase not supplied, ordered separately
- 20 tests per kit, REF 4-360
The Viennalab CVD StripAssay T determines nine variants that together make up a thrombophilia and cardiovascular risk profile, in a single reverse hybridisation run.
Variants covered
Factor V G1691A (Leiden) and Factor V H1299R (R2); prothrombin G20210A; MTHFR C677T and A1298C; Factor XIII V34L; PAI-1 4G/5G; and EPCR A4600G and G4678C. The IFU prints only this legacy nomenclature, without protein designations or HGVS notation.
Clinical background
Factor V Leiden and prothrombin G20210A are the two most frequent hereditary risk factors for venous thromboembolism. The MTHFR variants affect homocysteine metabolism, PAI-1 4G/5G affects fibrinolytic capacity, Factor XIII V34L is described as protective, and the EPCR variants concern the endothelial protein C receptor. A profile of this kind is determined in the work-up of unexplained thrombosis or a positive family history, and the interpretation depends on the combination rather than on a single variant.
Method and sample
The assay amplifies with biotinylated primers and hybridises the products to allele-specific probes on a test strip, detected with streptavidin-alkaline phosphatase and a colour substrate and read by eye against the supplied Collector sheet. Fresh or frozen blood with EDTA or citrate as anticoagulant is used; blood with heparin is not suitable. The kit contains the lysis solution and GENxTRACT resin for releasing DNA from whole blood. Taq DNA Polymerase is not supplied and is ordered separately as ViennaLab TAQ-500 or TAQ-2500. For DNA prepared outside the kit protocol, a concentration of 2 to 10 ng/µl is recommended, which is 10 to 50 ng per reaction.
- Lysis Solution (50 ml)
- GENXTRACTTM Resin (5 ml)
- Amplification Mix (yellow cap, 500 µl)
- Taq Dilution Buffer (transparent cap, 500 µl)
- DNAT (blue cap, 1.5 ml)
- Typing Trays (3)
- Teststrips (20)
- Hybridization Buffer (white cap, 25 ml)
- Wash Solution A (white cap, 80 ml)
- Conjugate Solution (25 ml)
- Wash Solution B (80 ml)
- Color Developer (25 ml)
- CollectorTM Sheet (1)
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Brochure StripAssays
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