Use of a fully automated immunoassay for celiac disease screening in a pediatric population

Background: Celiac disease (CD) is an immune-mediated disorder of the small bowel in which gluten and related cereal ingestion leads to chronic inflammation and damage to the small bowel mucosa in genetically susceptible individuals. The presence of IgA type tissue-transglutaminase antibodies (IgA-anti-tTG) in individuals without IgA deficiency is a highly-specific indicator of CD. We compared the accuracy of IgA-anti-tTG detection using a fully automated fluoroenzyme immunoassay (FEIA) with that of the standard enzyme-linked immunosorbent assay (ELISA) in a clinical setting. Methods: We tested 1227 serum samples obtained from three groups of subjects: 1160 randomly selected schoolchildren, 36 pediatric patients with biopsy confirmed CD and 31 control children with biopsy confirmed normal small bowel mucosa. IgA-anti-tTG detection was compared using the FEIA method and the ELISA method, both of which use baculovirus-expressed recombinant human tissue-transglutaminase (tTG) as the antigen. Results: Both tests identified pediatric patients with CD equally well in the random population (0.34% with CI: 0.09%-0.88%). Furthermore, both tests gave similar results for the CD group and the control group with normal small bowel mucosa (sensitivity: 90% and specificity: 100% for both assays). Conclusions: The FEIA method is an equivalent substitute for the traditional ELISA for IgA-anti-tTG detection associated with CD in a random pediatric population.