Abstract
Background and Objective: The diagnosis of Celiac Disease (CD) is first based on the positivity for specific serological markers. The CytoBead CeliAK immunoassay simultaneously measures antibodies (IgA) directed to tissue transglutaminase (tTG), endomysium (EMA), and deamidated gliadin (DG), in addition to providing a control for total IgA levels. The aim of this study is to assess the reliability of this multiplex assay to detect anti-tTG IgA positive patients, compared with a conventional single-parameter enzyme-linked immunosorbent assay (ELISA).Methods: Serum samples from 149 pediatric patients were assessed by both CytoBead CeliAK immunoassay and ELISA, in order to evaluate their concordance for the measurement of anti-tTG IgA.Results: The measurement of anti-tTG IgA by CytoBead CeliAK immunoassay basically showed a complete concordance rate with the conventional and single-parameter ELISA, according to the respective cutoff values (3 U/ml and 10 U/ml).Conclusions: Our comparative analysis demonstrates a substantial equivalency between multiplex CytoBead CeliAK assay and the single-parameter conventional ELISA to assess anti-tTG IgA antibody in the context of the screening for CD in children. Importantly, CytoBead CeliAK assay could present some preanalytic, analytic, and economic advantages.
Highlights
Celiac disease (CD) is a systemic immune-mediated disorder characterized by a very variable clinical expression, which ranges from classical symptoms of malabsorption to mild gastrointestinal complaints, passing through a multitude of different extra-gastrointestinal manifestations, that can be isolated or combined with the former [1].Multiplex Assay for Celiac DiseaseImportantly, CD in children can be even asymptomatic and, in these cases, can be investigated only later during adolescence or adulthood, because of some long-term complications, such as growth impairment, pubertal disorders, bone density reduction, fertility issues, occurrence of intestinal malignancy, and/or other autoimmune disorders [2, 3]
The diagnostic workup starts with serological investigations mainly assessing the presence of anti-tissue transglutaminase antibody and/or antiendomysium antibody (EMA), even though other markers may be variably used [8]
Anti-tissue transglutaminase (tTG) IgA performed by enzyme-linked immunosorbent assay (ELISA) resulted to be the most accurate marker to predict CD: its sensitivity and specificity are generally considered >90–95% [9, 10]
Summary
Celiac disease (CD) is a systemic immune-mediated disorder characterized by a very variable clinical expression, which ranges from classical symptoms of malabsorption to mild gastrointestinal complaints, passing through a multitude of different extra-gastrointestinal manifestations, that can be isolated or combined with the former [1].Multiplex Assay for Celiac DiseaseImportantly, CD in children can be even asymptomatic and, in these cases, can be investigated only later during adolescence or adulthood, because of some long-term complications, such as growth impairment, pubertal disorders, bone density reduction, fertility issues, occurrence of intestinal malignancy, and/or other autoimmune disorders [2, 3]. The diagnostic workup starts with serological investigations mainly assessing the presence of anti-tissue transglutaminase antibody (anti-tTG) and/or antiendomysium antibody (EMA), even though other markers may be variably used (e.g., anti-deamidated gliadin peptides, anti-gliadin antibody) [8]. Anti-tTG IgA performed by enzyme-linked immunosorbent assay (ELISA) resulted to be the most accurate marker to predict CD: its sensitivity and specificity are generally considered >90–95% [9, 10]. Their role in the diagnostic workup of CD in children was upgraded from screening to diagnostic test able to “replace” the histologic confirmation under some specific conditions, according to the ESPGHAN guidelines. The aim of this study is to assess the reliability of this multiplex assay to detect anti-tTG IgA positive patients, compared with a conventional single-parameter enzyme-linked immunosorbent assay (ELISA)
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