Assessment of a combination screening assay for celiac disease.

Purpose: A serological screening assay for celiac disease (CD), designed to simultaneously detect IgA and IgG anti-tissue transglutaminase (a-tTG) and IgA and IgG deamidated gliadin peptide antibodies (a-DGP), was recently developed. In this study, we establish the performance of this assay.

Methods: We enrolled 41 CD patients and 18 CD patients on gluten-free diets. The diagnosis of CD was based on histological and serological criteria, including concomitant positive serology tests (a-tTG, IgA anti-endomysial antibodies). As control population, we enrolled 169 subjects: 145 disease controls and 24 blood donors. In all cases, serum samples were tested for: IgA a-tTG, IgG a-tTG, IgA a-DGP, IgG a-DGP, IgA anti-endomysial antibodies (EMA), IgA and IgG for a-tTG and a-DGP in a single assay.

Results: The new test, QUANTA Lite (™) h-tTG/DGP Screen, detects all IgA and IgG antibodies against atTG and a-DGP present in a sample. In our study, the test showed 100% sensitivity and 91.12% specificity.

Conclusions: This study showed additional value of the new h-tTG/DGP Screen assay, which proved superior to more conventional assays and can be considered the best initial test for CD. Further studies are necessary to determine whether combination of h-tTG/DGP Screen with IgA a-tTG or IgA a-DGP can be used to obviate the need for duodenal biopsy in high- and low-risk populations.