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Validation of a new enzyme-linked immunosorbent assay to detect the triggering proteins and peptides for celiac disease: interlaboratory study.


The performance of Gluten-Tec (EuroProxima, Arnhem, The Netherlands) was tested through an interlaboratory study in accordance with AOAC guidelines. Gluten-Tec is a competitive ELISA that detects an immunostimulatory epitope of a-gliadin in dietary food for celiacs. Fifteen laboratories, representing 14 different countries, announced their interest in taking part in this study. Of the 12 laboratories that sent the results within the established timeframe, two submitted inappropriate standard curves and were excluded from the statistical analysis. Four different food matrixes (rice-based baby food, maize bread, chocolate cake mix, and beer) were selected for preparing the test samples. Two gliadin extraction procedures were used: the conventional 60% ethanol, and a new method based on the reducing reagent dithiothreitol. The 38 samples (19 blind duplicates) tested in this study were prepared by diluting the different extracts in order to cover a wide range of gliadin levels. Both sample extraction and dilution were performed by EuroProxima; the present interlaboratory study was focused only on testing the ELISA part of the Gluten-Tec kit protocol. Repeatability values (within-laboratory variance), expressed as RSD(r) ranged from 6.2 to 25.7%, while reproducibility values (interlaboratory variance), expressed as RSD(R), ranged from 10.6 to 45.9%. Both statistical parameters were in the acceptable range of ELISAs under these conditions, and the method will be presented to the Codex Alimentarius as a preferred method for gluten analysis.


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  • Authors+Show Affiliations


    Leiden University Medical Center, Department of Immunology and Blood Transfusion, Leiden, The Netherlands.

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    Celiac Disease
    Chromatography, High Pressure Liquid
    Dietary Proteins
    Enzyme-Linked Immunosorbent Assay
    Food Analysis
    Food Hypersensitivity
    Indicators and Reagents
    Infant Food
    Limit of Detection
    Reagent Kits, Diagnostic
    Reproducibility of Results

    Pub Type(s)

    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't
    Validation Studies



    PubMed ID