Tissue transglutaminase enzyme-linked immunosorbent assay as a screening test for celiac disease in pediatric patients.

OBJECTIVE An immunoglobulin A (IgA) anti-tissue transglutaminase antibody assay (anti-tTG) was compared with the conventional IgA anti-endomysium antibody assay (EMA) to assess its reliability as a screening test for celiac disease (CD) in a pediatric population. METHODS Seventy-five IgA-sufficient and 2 IgA-deficient children who were scheduled for small intestinal biopsy for the evaluation of history or symptoms suggesting a diagnosis of CD were prospectively evaluated and enrolled in this study (gastrointestinal [GI] patients). In addition, 16 children with type I diabetes mellitus (DM) who had a positive EMA and a small bowel biopsy were included as a separate cohort. IgA anti-tTG was measured by enzyme-linked immunosorbent assay (ELISA), and IgA-EMA titers were determined by indirect immunofluorescence on cryopreserved sections of monkey esophagus. RESULTS Nine of the 75 IgA-sufficient GI patients had a small bowel biopsy consistent with the diagnosis of CD. Eight of 9 IgA-sufficient patients with a positive small bowel biopsy had positive anti-tTG and EMA tests. Four IgA-sufficient patients had a false-positive anti-tTG ELISA and 2 had a false-positive IgA-EMA assay. In the IgA-sufficient patients, the sensitivity was 89% and the negative predictive value was 98% for either assay. The specificities of the IgA anti-tTG and the IgA-EMA tests were 94% and 97%, respectively (not significant). The positive predictive value of the IgA anti-tTG was 67%, compared with 80% for the IgA-EMA (not significant). In the 2 IgA-deficient children, one of whom had biopsy-proved CD, both tests were negative. In the 16 DM children 12 true- and 4 false-positive IgA anti-tTG and IgA-EMA results were identified. Three of 12 complained of GI symptoms. In follow-up, thus far, none of the DM patients with a false-positive anti-tTG have developed CD. CONCLUSIONS The IgA anti-tTG antibody assay is equivalent to the IgA-EMA assay as a screening test for CD in IgA-sufficient pediatric patients. Intestinal biopsy remains the gold standard for the diagnosis of CD.