EliGene® Coeliac

Intended use

EliGene® Coeliac RT is intended for the genotypization of:

• HLA-DQ2 (DQA1*05/DQB1*02)
• HLA-DQ8 (DQA1*03/DQB1*0302)
• HLA-DR4 (DRB1*04)

EliGene® Coeliac RT28 is intended for the genotypization of:

• HLA-DQ2.5 (DQA1*05/DQB1*02)
• DQ8 (DQB1*0302)

EliGene® Coeliac 3.0 RT is intended for the genotypization of:

• HLA-DQ2.5 (DQA1*05/DQB1*02)
• HLA-DQ2.2 (DQA1*02/DQB1*02) 
• HLA-DQ8 (DQA1*03/DQB1*0302)

Principle of the method

This diagnostic kits are based on RealTime PCR method. In this kits primers and labeled probes (FAM and JOE) for the detection of alleles and for the detection of internal control are used.

Compatible instruments

The following list represents instruments on which the above mentioned kits were tested. Please contact us for compatibility with other instruments.

• Roche: LightCycler® 480, LightCycler® Nano
• Thermofisher Scientific: Quant Studio 3 a 5
• Applied Biosystems: ABI 7000, 7300, 7500FAST
  
• Qiagen: RotorGene 6000 nebo Q
• Bio -Rad: CFX96 Touch Real -Time PCR Detection System

Clinical material and recommended DNA isolation procedure

Blood

Manual: EliGene Urine Isolation Kit (ELISABETH PHARMACON)
Automatic: MAGNETO BodyFluid DNA/RNA Isolation Kit (for equipment ZEPHYRUS Magneto)

Swabs

Manual: EliGene Urine Isolation Kit (ELISABETH PHARMACON)
Automatic: MAGNETO BodyFluid DNA/RNA Isolation Kit (for equipment ZEPHYRUS Magneto)

General information

Coeliac disease, also called celiac sprue is one of the most common enteropathogenic disorders and is characterized by a lifelong hypersensitivity to gluten proteins found in wheat, rye, oat and barley. Celiac disease does not belong to allergic disease but it is characterized by intolerance to gliadin forming parts of gluten. In early childhood the immunological intolerance to gliadin, leads to a chronic inflammatory response in the small-intestinal mucosa and subsequent malabsorption characterized by chronic diarrhea, steatorrhea and failure to thrive. Many adult patients can also show other atypical signs such as, abdominal distention, weight loss, fatigue, skin- and joint problems or migraine-like headache. Indeed, others may remain largely asymptomatic. Non-treated celiac disease increases the risk of NHL (non-Hodgkin's lymphoma) and probably small-intestinal cancer.
Until recently, coeliac disease was considered relatively uncommon with an estimated prevalence rate ranging from 1 in 1000 to 1:4000. However, the availability of new serologic tests have led to the observation that coeliac disease is much more common, affecting about 1 of 100-400 persons in Europe, the majority of patients showing little clinical symptoms. Considerable evidence now indicates that celiac disease has a strong genetic component.

CE IVD