Volume 153, Issue 2, Pages 410-419.e17 (August 2017) Validation of Antibody-Based Strategies for Diagnosis of Pediatric Celiac Disease Without Biopsy  Johannes Wolf, David Petroff, Thomas Richter, Marcus K.H. Auth, Holm H. Uhlig, Martin W. Laass, Peter Lauenstein, Andreas Krahl, Norman Händel, Jan de Laffolie, Almuthe C. Hauer, Thomas Kehler, Gunter Flemming, Frank Schmidt, Astor Rodrigues, Dirk Hasenclever, Thomas Mothes  Gastroenterology  Volume 153, Issue 2, Pages 410-419.e17 (August 2017) DOI: 10.1053/j.gastro.2017.04.023 Copyright © 2017 AGA Institute Terms and Conditions

Figure 1 Scatterplot showing the relation between IgA-TTG and IgG-DGL. The solid and dashed rectangles denote 1× ULN and 10× ULN, respectively. A linear correlation coefficient was calculated and the corresponding CI was determined using the Fisher transformation. An orthogonal regression line was fitted and the correlation analyses were performed after excluding sIgAD patients. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Figure 2 Results of antibody assays. Antibody concentration range as multiples of upper limit of normal with number of patients indicated in boxes; IgA-EMA+, number of IgA-EMA positive patients. § One IgA-EMA test was unavailable NFD, no final diagnosis possible; sIgAD, number of selective IgA-deficient patients. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Figure 3 Predictive values of the test procedures as they depend on prevalence. PPV and NPV (solid lines) plotted as functions of the prevalence together with a 95% LCB (dashed lines). In the upper panel the procedures are virtually indistinguishable for PPV (404 of 409 in the TTG-IgA procedure and 405 of 410 in the TTG-DGL procedure at the observed prevalence of 59%, blue curve covered by red curve). The range of disease prevalence for which the TTG-DGL procedure is reliable (4%−63%) is shown by gray shading. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 1 Simplified study procedure. ∗Feedback was given after GFD decision (no later than 3 months after inclusion), but only if blood, histology slides, and all data of visit 1 and visit 2 were available. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 2 Trial recruitment. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 3 Distribution of patient accrual and diagnoses by trial site. Leipzig I, University Children’s Hospital Leipzig, Germany; Leipzig II, Children’s Hospital of the Clinical Centre “Sankt Georg” Leipzig, Germany. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 4 Intra-individual variance. The last available local IgA-TTG concentration is plotted against the value measured in the central laboratory in units of ULN. More than half the tests were performed within 1 week of each other. The intra-individual SD is provided using a robust estimate based on median absolute deviations. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 5 Antibody distribution for non-CD patients. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 6 Sensitivity Analyses. Gastroenterology 2017 153, 410-419.e17DOI: (10.1053/j.gastro.2017.04.023) Copyright © 2017 AGA Institute Terms and Conditions