Celiac hs Screen WIESLAB® - Discontinued

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Wieslab® Celiac hs Screen assay is based on a unique synthetic deamidated gliadin peptide containing a well-defined T-cell stimulatory toxic epitope, which is known to be involved in celiac disease.

Product code
CELI SC
Format
ELISA
Tests
96 wells
Calculation
Semi-quantitative
Antigen
Unique gluten derived, deamidated peptide
Units
U/mL
Calibrators
6
Range
0-200 U/mL
Incubation time
60+30+30 min
Detection system
405 nm
Availability
CE marked. Available in US only for research use, not for IVD use

Intended use

The Wieslab® Celiac hs Screen kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies in human serum to celiac disease (CD) specific peptide antigen. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of celiac disease. The analysis should be performed by trained laboratory professionals.

FOR IN VITRO DIAGNOSTIC USE.

This product is also available as research use only. Product code: CELI SC RUO

For complete product description, claims and use, please refer to the Instructions For Use. Contact your local representative for availability in your country.

Background

Celiac disease is caused by intolerance to gluten, a complex mixture of proteins found in wheat, barley and rye. Once the disease has developed it can only be treated by the introduction of a lifelong gluten-free diet.

It is generally accepted that the prevalence of celiac disease is 0.5 to 1% in the Western Hemisphere and a similar occurrence is likely in North Africa, the Middle East, India and parts of China. This makes celiac disease one of the most prevalent food induced disorders known. Most of those patients, however, are not diagnosed due to the diversity of symptoms associated with celiac disease, general lack of knowledge about celiac disease among general practitioners and gastroenterologists, and the invasive endoscopic procedure that is still regarded necessary for a proper diagnosis.

It is now well established that celiac disease is caused by aberrant T-cell mediated immune responses to the gluten proteins. This inflammatory T- cell response leads to the tissue destruction and remodelling that is typically found in the upper small intestine of celiac disease patients and resolves on a gluten-free diet. Strikingly, such T-cell responses are largely directed against modified gluten proteins. The modification, the conversion of the amino acid glutamine into glutamic acid, is introduced due to the activity of the enzyme tissue transglutaminase 2 in the small intestine. As a by-product of the T-cell response to modified gluten, patients usually also produce antibodies to both tissue transglutaminase 2 and modified gluten. As these antibodies are secondary to the T-cell response to gluten, their presence is highly predictive for celiac disease.

Technical information

The wells of the microtiter plate are coated with purified synthetic peptide antigen. The antigen is a unique gluten derived, deamidated peptide, recognized by T-cells in the initial immune response of celiac disease.

During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.

The wells are then washed to remove unbound antibodies and other components.

A conjugate of alkaline phosphatase-labelled antibodies to human IgG binds to the antibodies in the wells in the second incubation.

After a further washing step, detection of specific antibodies is obtained by incubation with a substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is calculated against a calibrator curve and the results are given in arbitrary U/mL.

Kit components

- One frame with 96 wells coated with peptide, with lid, sealed in a foil pack with a dry pack

- 1.5 mL negative control (NC) containing human serum in diluent (green colour)

- 1.5 mL positive control (PC) containing human serum in diluent (red colour)

- 13 mL conjugate containing alkaline phosphatase labelled antibodies to human IgG (blue colour)

- 2 x 32 mL Diluent (Dil) containing PBS (red colour)

- 13 mL Substrate pNPP

- 13 mL Stop solution

- 30 mL Wash solution 30x concentrated

- Six calibrators (five calibrators, Cal 2-6, containing human serum) in diluent (red colour). 1.5 mL Cal 1 = 0 U/mL, 1.5 mL Cal 2 = 2 U/mL, 1.5 mL Cal 3 = 10 U/mL, 1.5 mL Cal 4 = 30 U/mL, 1.5mL Cal 5 = 100 U/mL, 1.5 mL Cal 6 = 200 U/mL.

Storage of reagents

All reagents in the kit are ready to use, except wash solution, and should be stored at 2-8°C. Remove only the number of wells needed for testing, reseal the aluminium package carefully.