Beta Thalassemia StripAssay (β-Globin), tap a thumbnail to see more views.
Beta Thalassemia StripAssay (β-Globin)
The Viennalab Beta Thalassemia StripAssay identifies 22 mutations in the HBB gene by PCR followed by reverse hybridisation on a test strip. The assay comes in three region-specific versions, each covering more than 90 per cent of the beta-globin defects in its population: MED for the Mediterranean (REF 4-130), IME for India, Iran, the Middle East and the Arabian Peninsula (REF 4-140) and SEA for Southeast Asia (REF 4-150). Beta thalassemia is caused by mutations in HBB that reduce or abolish beta-globin production. Because the mutation spectrum differs strongly per region, the version has to match the population being tested.
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This kit in detail
- 22 HBB mutations per version, over 90 per cent regional coverage
- Three versions: MED (REF 4-130), IME (REF 4-140) and SEA (REF 4-150)
- MED also covers the haemoglobin variants HbS and HbC
- SEA covers HbE, the dominant variant in Southeast Asia
- Lysis solution and resin supplied; Taq DNA Polymerase is not
- 20 tests per kit, fresh or frozen EDTA or citrate blood
The Viennalab Beta Thalassemia StripAssay identifies mutations in the beta-globin gene, for the diagnosis of beta thalassemia and the sickle cell disorders, and for carrier and prenatal testing. The intended use in the IFU is the identification of beta-globin gene mutations based on PCR and reverse hybridisation.
Choosing the right version
The mutation spectrum of HBB differs per region, so the assay exists in three versions, each with 22 mutations covering more than 90 per cent of the beta-globin defects in its population. MED (REF 4-130) is the Mediterranean type, IME (REF 4-140) the Indian and Middle Eastern type, and SEA (REF 4-150) the Southeast Asian type. The panels are not interchangeable: MED contains the haemoglobin variants HbS (codon 6 [A to T]) and HbC (codon 6 [G to A]), which the SEA panel does not, while SEA contains HbE at codon 26, the most frequent variant in Southeast Asia.
The MED panel in full
Point mutations -101 [C to T], -87 [C to G], -30 [T to A], codon 6 [G to A] HbC, codon 6 [A to T] HbS, codon 15 [TGG to TGA], codon 27 [G to T] Knossos, IVS 1.1 [G to A], IVS 1.5 [G to C], IVS 1.6 [T to C], IVS 1.110 [G to A], IVS 1.116 [T to G], IVS 1.130 [G to C], codon 39 [C to T], IVS 2.1 [G to A], IVS 2.745 [C to G] and IVS 2.848 [C to A]; the deletions codon 5 [-CT], codon 6 [-A], codon 8 [-AA] and codon 44 [-C]; and the insertion codon 8/9 [+G]. Reference sequence NM_000518.4.
Method and sample
The assay amplifies with biotinylated primers and hybridises the products to allele-specific probes immobilised as parallel lines on a test strip. Bound product is detected with streptavidin-alkaline phosphatase and a colour substrate, and the pattern is read by eye against the supplied Collector sheet. Fresh or frozen blood with EDTA or citrate as anticoagulant is used, and 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, 2 to 20 ng/µl is specified, which is 10 to 100 ng per reaction.
Related assays
For alpha-globin defects the Alpha Thalassemia StripAssay covers 21 defects in HBA1 and HBA2, and the Beta Thalassemia Modifier StripAssay determines the polymorphisms that influence the severity of beta thalassemia.
- Lysis Solution (50 ml)
- GENxTRACT Resin (5 ml)
- Amplification Mix (500 µl)
- Taq Dilution Buffer (500 µl)
- DNAT (1.5 ml)
- Typing Trays (3)
- Teststrips (20)
- Hybridization Buffer (25 ml)
- Wash Solution A (80 ml)
- Conjugate Solution (25 ml)
- Wash Solution B (80 ml)
- Color Developer (25 ml)
- Instructions For Use (1)
- Collector Sheet (1)
20 tests per kit. REF 4-130 (MED), REF 4-140 (IME) and REF 4-150 (SEA). Taq DNA Polymerase is not supplied and is ordered separately as ViennaLab TAQ-500 or TAQ-2500. Fresh or frozen blood with EDTA or citrate anticoagulant is used; for DNA prepared with another method, 2 to 20 ng/µl is specified.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Frequently paired with this kit
Other assays and instruments lab teams add alongside the Beta Thalassemia StripAssay (β-Globin).
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