1. Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice
- Author
-
Werkstetter, K.J. Korponay-Szabó, I.R. Popp, A. Villanacci, V. Salemme, M. Heilig, G. Lillevang, S.T. Mearin, M.L. Ribes-Koninckx, C. Thomas, A. Troncone, R. Filipiak, B. Mäki, M. Gyimesi, J. Najafi, M. Dolinšek, J. Dydensborg Sander, S. Auricchio, R. Papadopoulou, A. Vécsei, A. Szitanyi, P. Donat, E. Nenna, R. Alliet, P. Penagini, F. Garnier-Lengliné, H. Castillejo, G. Kurppa, K. Shamir, R. Hauer, A.C. Smets, F. Corujeira, S. van Winckel, M. Buderus, S. Chong, S. Husby, S. Koletzko, S. Socha, P. Cukrowska, B. Szajewska, H. Wyhowski, J. Brown, N. Batra, G. Misak, Z. Seiwerth, S. Dmitrieva, Y. Abramov, D. Vandenplas, Y. Goossens, A. Schaart, M.W. Smit, V.T.H.B.M. Kalach, N. Gosset, P. Kovács, J.B. Nagy, A. Lellei, I. Kőbányai, R. Khatami, K. Monajemzadeh, M. Dimakou, K. Patereli, A. Hansen, T.P. Kavalar, R. Bolonio, M. Ramos, D. Kogler, H. Amann, G. Kosova, R. Maglio, M. Janssens, E. Achten, R. Frűhauf, P. Skálová, H. Kirchner, T. Petrarca, L. Magliocca, F.M. Martínez, F. Morente, V. Thanner-Lechner, S. Ratschek, M. Gasparetto, M. Hook, L. Canioni, D. Wanty, C. Mourin, A. Laurila, K. Vornane, M. Friedler, V.N. Morgenstern, S.L. Amil Dias, J. Carneiro, F. João, H.S. Van Biervliet, S. Velde, S.V. Banoub, H. Sampson, S. Müller, A.M. Ene, A. Rafeey, M. Eftekhar Sadat, A.T. ProCeDE study group ProCeDE study group and Werkstetter, K.J. Korponay-Szabó, I.R. Popp, A. Villanacci, V. Salemme, M. Heilig, G. Lillevang, S.T. Mearin, M.L. Ribes-Koninckx, C. Thomas, A. Troncone, R. Filipiak, B. Mäki, M. Gyimesi, J. Najafi, M. Dolinšek, J. Dydensborg Sander, S. Auricchio, R. Papadopoulou, A. Vécsei, A. Szitanyi, P. Donat, E. Nenna, R. Alliet, P. Penagini, F. Garnier-Lengliné, H. Castillejo, G. Kurppa, K. Shamir, R. Hauer, A.C. Smets, F. Corujeira, S. van Winckel, M. Buderus, S. Chong, S. Husby, S. Koletzko, S. Socha, P. Cukrowska, B. Szajewska, H. Wyhowski, J. Brown, N. Batra, G. Misak, Z. Seiwerth, S. Dmitrieva, Y. Abramov, D. Vandenplas, Y. Goossens, A. Schaart, M.W. Smit, V.T.H.B.M. Kalach, N. Gosset, P. Kovács, J.B. Nagy, A. Lellei, I. Kőbányai, R. Khatami, K. Monajemzadeh, M. Dimakou, K. Patereli, A. Hansen, T.P. Kavalar, R. Bolonio, M. Ramos, D. Kogler, H. Amann, G. Kosova, R. Maglio, M. Janssens, E. Achten, R. Frűhauf, P. Skálová, H. Kirchner, T. Petrarca, L. Magliocca, F.M. Martínez, F. Morente, V. Thanner-Lechner, S. Ratschek, M. Gasparetto, M. Hook, L. Canioni, D. Wanty, C. Mourin, A. Laurila, K. Vornane, M. Friedler, V.N. Morgenstern, S.L. Amil Dias, J. Carneiro, F. João, H.S. Van Biervliet, S. Velde, S.V. Banoub, H. Sampson, S. Müller, A.M. Ene, A. Rafeey, M. Eftekhar Sadat, A.T. ProCeDE study group ProCeDE study group
- Abstract
Background & Aims The guidelines of the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition allow for diagnosis of celiac disease without biopsies in children with symptoms and levels of immunoglobulin A against tissue-transglutaminase (TGA-IgA) 10-fold or more the upper limit of normal (ULN), confirmed by detection of endomysium antibodies (EMA) and positivity for HLA-DQ2/DQ8. We performed a large, international prospective study to validate this approach. Methods We collected data from consecutive pediatric patients (18 years or younger) on a gluten-containing diet who tested positive for TGA-IgA from November 2011 through May 2014, seen at 33 pediatric gastroenterology units in 21 countries. Local centers recorded symptoms; measurements of total IgA, TGA, and EMA; and histopathology findings from duodenal biopsies. Children were considered to have malabsorption if they had chronic diarrhea, weight loss (or insufficient gain), growth failure, or anemia. We directly compared central findings from 16 antibody tests (8 for TGA-IgA, 1 for TGA-IgG, 6 for IgG against deamidated gliadin peptides, and 1 for EMA, from 5 different manufacturers), 2 HLA-DQ2/DQ8 tests from 2 manufacturers, and histopathology findings from the reference pathologist. Final diagnoses were based on local and central results. If all local and central results were concordant for celiac disease, cases were classified as proven celiac disease. Patients with only a low level of TGA-IgA (threefold or less the ULN) but no other results indicating celiac disease were classified as no celiac disease. Central histo-morphometry analyses were performed on all other biopsies and cases were carefully reviewed in a blinded manner. Inconclusive cases were regarded as not having celiac disease for calculation of diagnostic accuracy. The primary aim was to determine whether the nonbiopsy approach identifies children with celiac disease with a positive predictive value (PPV) above 99% in c
- Published
- 2017