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Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice

التفاصيل البيبلوغرافية
العنوان: Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice
المؤلفون: Sven Seiwerth, Annette M. Müller, Manfred Ratschek, Bożena Cukrowska, Gemma Castillejo, Vanesa Morente, Jorge Amil Dias, Sara Morgenstern, Marco Gasparetto, Nailah Brown, Alexandra Papadopoulou, Gabriele Amann, Kalle Kurppa, Vincenzo Villanacci, Almuthe C. Hauer, Francesc Martínez, Miguel Bolonio, Anikó Nagy, Tine Plato Hansen, Yvan Vandenplas, Sonja Thanner-Lechner, Kaija Laurila, Rita Kőbányai, Søren Thue Lillevang, Zrinjka Mišak, Riccardo Troncone, Pavel Frűhauf, Adina Ene, Jernej Dolinsek, Konstantina Dimakou, Fabio Massimo Magliocca, Annieta Goossens, Vered Nachmias Friedler, Maryam Monajemzadeh, Amir Taher Eftekhar Sadat, Mandana Rafeey, Jan Wyhowski, Rafaella Nenna, Françoise Smets, Hélène Garnier-Lengliné, Marianna Salemme, Martine Vornane, Stine Dydensborg Sander, Hany Banoub, Anne Mourin, Mariantonia Maglio, Stephanie Van Biervliet, Birgit Filipiak, M. L. Mearin, Mehri Najafi, Gauri Batra, Judit Gyimesi, Hubert Kogler, Gabriele Heilig, Raanan Shamir, Laura Petrarca, Katayoun Khatami, Myriam Van Winckel, Susana Corujeira, Hania Szajewska, Ilma Rita Korponay-Szabó, Alina Popp, Stefan Buderus, Sonny K. F. Chong, Elke Janssens, Francesca Penagini, Vincent T.H.B.M. Smit, Judit B. Kovács, Rajko Kavalar, Thomas Kirchner, Carmen Ribes-Koninckx, Renata Auricchio, Ruth Achten, Ester Donat, Catherine Wanty, Nicolas Kalach, Danielle Canioni, Philippe Alliet, Ilona Lellei, Sibylle Koletzko, Yulia Dmitrieva, Fátima Carneiro, Liz Hook, David Fernández Ramos, Roberta Kosova, Dmitry Abramov, Markku Mäki, Helena Skalova, Adrian G. Thomas, Steffen Husby, Steve Sampson, Katharina Julia Werkstetter, Piotr Socha, Andreas Vécsei, Amalia Patereli, Peter Szitanyi, Saskia Vande Velde, Maaike W. Schaart, Pierre Gosset
المساهمون: Growth and Development, Clinical sciences, 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, Riccardo, Filipiak, B, Mäki, M, Gyimesi, J, Najafi, M, Dolinšek, J, Dydensborg Sander, S, Auricchio, Renata, Papadopoulou, A, Vécsei, A, Szitanyi, P, Donat, E, Nenna, R, Alliet, Ph, 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, Piotr, Bozena Cukrowska, Null, Szajewska, Hania, Wyhowski, Jan, Brown, Nailah, Batra, Gauri, Misak, Zrinjka, Seiwerth, Sven, Dmitrieva, Yulia, Abramov, Dmitry, Vandenplas, Yvan, Goossens, Annieta, Schaart, Maaike W, Smit, V. T. H. B. M, Kalach, Nicola, Gosset, Pierre, Kovács, Judit B, Nagy, Anikó, Lellei, Ilona, Kőbányai, Rita, Khatami, Katayoun, Monajemzadeh, Maryam, Dimakou, Konstantina, Patereli, Amalia, Plato Hansen, Tine, Kavalar, Rajko, Bolonio, Miguel, Kogler, Hubert, Amann, Gabriele, Kosova, Roberta, Maglio, Mariantonia, Janssens, Elke, Achten, Ruth, Frűhauf, Pavel, Skálová, Helena, Kirchner, Thoma, Petrarca, Laura, Magliocca, Fabio Massimo, Martínez, Francesc, Morente, Vanesa, Thanner Lechner, Sonja, Ratschek, Manfred, Gasparetto, Marco, Hook, Liz, Canioni, Danielle, Wanty, Catherine, Mourin, Anne, Laurila, Kaija, Vornane, Martine, Nachmias Friedler, Vered, Morgenstern, Sara L, Amil Dias, Jorge, Carneiro, Fátima, Van Biervliet, Stephanie, Vande Velde, Saskia, Banoub, Hany, Sampson, Steve, Müller, Annette M, Ene, Adina, Rafeey, Mandana, Eftekhar Sadat, Iran Amir Taher
المصدر: 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, Bozena Cukrowska, Szajewska, H, Wyhowski, J, Brown, N, Batra, G, Misak, Z, Seiwerth, S, Dmitrieva, Y, Abramov, D, Vandenplas, Y, Goossens, A, Plato Hansen, T & ProCeDE study group 2017, ' Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice ', Gastroenterology, vol. 153, no. 4, pp. 924–935 . https://doi.org/10.1053/j.gastro.2017.06.002
Gastroenterology, 153(4), 924-935
Gastroenterology
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
instname
سنة النشر: 2017
مصطلحات موضوعية: Male, Autoimmunity, ESPGHAN, nonbiopsy approach, ProCeDE study, adolescent, autoantibodies, biomarkers, biopsy, celiac disease, child, child preschool, Europe, female, GTP-binding proteins, HLA-DQ antigens, humans, immunoglobulin A, infant, intestine small, male, Middle East, molecular diagnostic techniques, predictive value of tests, prognosis, prospective studies, reproducibility of results, serologic tests, transglutaminases, Biopsy, gastroenterology, non-biopsy approach, HLA-DQ Antigens/genetics, 0302 clinical medicine, Immunoglobulin A/blood, Intestine, Small, Nonbiopsy Approach, Prospective Studies, Prospective cohort study, Child, education.field_of_study, medicine.diagnostic_test, Orvostudományok, Prognosis, Multicenter Study, medicine.anatomical_structure, Molecular Diagnostic Techniques, Transglutaminases/immunology, Predictive value of tests, Child, Preschool, 030211 gastroenterology & hepatology, Female, Intestine, Small/immunology, medicine.medical_specialty, Child, preschool, Adolescent, Anemia, Population, Celiac Disease/blood, Klinikai orvostudományok, 03 medical and health sciences, autoimmunity, proCeDE study, GTP-Binding Proteins, Predictive Value of Tests, 030225 pediatrics, Internal medicine, HLA-DQ Antigens, medicine, Journal Article, Humans, Protein Glutamine gamma Glutamyltransferase 2, Serologic Tests, Validation Studies, education, Pediatric gastroenterology, GTP-Binding Proteins/immunology, ProCeDE Study, Transglutaminases, business.industry, Infant, Reproducibility of Results, Hepatology, Endomysium, medicine.disease, Surgery, Immunoglobulin A, Celiac Disease, hepatology, business, Autoantibodies/blood, Biomarkers/blood
الوصف: 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 clinical practice. Secondary aims included comparing performance of different serological tests and to determine whether the suggested criteria can be simplified. Results Of 803 children recruited for the study, 96 were excluded due to incomplete data, low level of IgA, or poor-quality biopsies. In the remaining 707 children (65.1% girls; median age, 6.2 years), 645 were diagnosed with celiac disease, 46 were found not to have celiac disease, and 16 had inconclusive results. Findings from local laboratories of TGA-IgA 10-fold or more the ULN, a positive result from the test for EMA, and any symptom identified children with celiac disease (n = 399) with a PPV of 99.75 (95% confidence interval [CI], 98.61–99.99); the PPV was 100.00 (95% CI, 98.68–100.00) when only malabsorption symptoms were used instead of any symptom (n = 278). Inclusion of HLA analyses did not increase accuracy. Findings from central laboratories differed greatly for patients with lower levels of antibodies, but when levels of TGA-IgA were 10-fold or more the ULN, PPVs ranged from 99.63 (95% CI, 98.67–99.96) to 100.00 (95% CI, 99.23–100.00). Conclusions Children can be accurately diagnosed with celiac disease without biopsy analysis. Diagnosis based on level of TGA-IgA 10-fold or more the ULN, a positive result from the EMA tests in a second blood sample, and the presence of at least 1 symptom could avoid risks and costs of endoscopy for more than half the children with celiac disease worldwide. HLA analysis is not required for accurate diagnosis. Clinical Trial Registration no: DRKS00003555.
وصف الملف: application/pdf
اللغة: English
تدمد: 0016-5085
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d58f1af4099e2da2bd4eda72a440c74e
https://portal.findresearcher.sdu.dk/da/publications/6f793e5b-e174-4a08-8bb4-e677fb68088c
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....d58f1af4099e2da2bd4eda72a440c74e
قاعدة البيانات: OpenAIRE
الوصف
تدمد:00165085