Anti-DGP IgG ELISA Kit (Anti-Deamidated Gliadin Protein)
INTENDED USE
Human anti-DGP IgG ELISA kit is a procedure for detecting in vitro quantitative amounts of anti IgG-antibodies directed against anti deamidated gliadin protein epitopes (anti-DGP IgG, anti DGP IgG) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.
BACKGROUND
Anti gliadin antibodies are produced in response to gliadin and the use of antibodies against gliadin have been vital in the diagnosis of celiac disease. There are essentially three different alleles AA, BB and DD and these can lead to a slightly different gliadins being produced in the body. The major disadvantage of using gliadin antibodies is that they are also present in individuals without celiac disease, meaning that they lack specificity even though they are quite sensitivity in comparison to measuring endomysium and transglutaminase concentrations.
Recent findings have identified that gliadin-reactive antibodies from celiac patients are able to bind a limited number of specific epitopes which are locate that on the gliadin molecule. This means that the use of deamidated gliadin peptides (anti-DGP IgG and anti-DGP IgA) in assay’s will allow a greater specificity and accuracy for determining celiac disease in comparison to the standard gliadin antibody assays.
In serum samples from celiac patients both IgA and IgG antibodies against deamidated gliadin peptide epitopes have been identified. The IgG antibody (DGP IgG) is quite similar to AGA IgA, however, it can be found at higher amounts in patients with the IgA-less phenotype.
CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Divisible Microplate: Consisting of 12 modules of 8 wells each, deamidated gliadin proteins are bound to microwells.
- Calibrator A-F: Concentration 0, 6.3, 12.5, 25, 50, 100 U/ml.
- Control Positive and Control Negative.
- Sample Buffer P (5x).
- Enzyme Conjugate: Consists of anti-human IgG antibodies, HRP labelled.
- Substrate: Tetramethylbenzidin (TMB).
- Stop Solution: Contains acid.
- Wash Buffer (50x).
- Instruction for Use.
- Certificate of Analysis.
SENSITIVITY
The minimum detection sensitivity level of anti-deamidated gliadin protein epitopes (anti DGP IgG) using current anti-DGP IgG ELISA kit was 1.0 U/ml. The dynamic range for this assay is 6.3 – 100.0 U/ml.
ASSAY CHARACTERISTICS
– Limit Of Detection (LOD): Functional sensitivity is 1 U/ml
– Expected Values: Healthy blood donors display a cut-off 10 U/ml
– Results Interpretation: Negative: < 10 U/ml Positive: ≥ 10 U/ml
– Measuring Range: 0 – 100 U/ml.
– Intra Assay: 4.3 – 5.8%
– Inter Assay: 2.5 – 4.1%
– Linearity: 97 – 117%
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (92.5%), Specificity (100.0%), Overall agreement (96.77%).
REFERENCES
- Diagnostic value of anti-deamidated gliadin peptide IgG antibodies for celiac disease in children and IgA-deficient patients. J Pediatr Gastroenterol Nutr. (2012) 55 (1): 50-5. Mozo L., et al.
- The clinical response to gluten challenge: a review of the literature. Nutrients. (2013) 5 (11): 4614-41. Review. Bruins M.J.
- Serological testing for celiac disease in adults. United European Gastroenterol J. (2013) 1 (5): 319-25. Schyum A.C. and Rumessen J.J.
- Diagnostic performance of IgG anti-deamidated gliadin peptide antibody assays is comparable to IgA anti-tTG in celiac disease. Clin Chim Acta. (2010) 411 (13-14): 931-5. Vermeersch P., et al.
ADDITIONAL INFORMATION
- Full Name: Anti-DGP IgG ELISA Kit (Anti-Deamidated Gliadin Protein)
- Reactivity: Human
- Sample Type: Serum, Plasma
- Sensitivity: 1.0 U/ml
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