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Cover of Diagnosis of Celiac Disease

Diagnosis of Celiac Disease

Comparative Effectiveness Reviews, No. 162

Investigators: , MPP, , MBChB, , MS, , PhD, , PhD, , BA, , MLS, , MPhil, , MS, , MD, PhD, and , MD.

Author Information
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 15(16)-EHC032-EF

Structured Abstract


To report the evidence on comparative accuracy and safety of methods used in current clinical practice to diagnose celiac disease, including serological tests, human leukocyte antigen (HLA) typing, and video capsule endoscopy. Diagnostic tests used singly and in combination in various populations were compared against the reference standard of endoscopic duodenal biopsy. In addition, factors affecting biopsy accuracy were reviewed.

Data sources:

Electronic searches of PubMed®, Embase®, the Cochrane Library, and Web of Science from 1990 through March 2015. Reference lists of included publications were searched for additional relevant studies, and experts were asked to suggest studies.

Review methods:

Studies of diagnostic accuracy were included if all participants underwent the index test and endoscopy with duodenal biopsy as the reference standard. Systematic reviews on accuracy and studies on adverse events associated with testing were included. Standard assessment tools were used to evaluate study risk of bias. Where possible, results of accuracy studies were pooled using meta-analysis. When pooling was not possible, findings were described narratively and presented in tables and figures.


A total of 7,254 titles were identified, from which 60 individual studies and 13 prior systematic reviews were included. The majority of studies were conducted in participants with symptoms. New meta-analyses found high-strength evidence to support excellent accuracy of anti-tissue transglutaminase (tTG) immunoglobulin A (IgA) tests (sensitivity = 92.5%; specificity = 97.9%) and excellent specificity of endomysial antibodies (EmA) IgA tests (sensitivity = 79.0%; specificity = 99.0%), as reported in previous systematic reviews. Promising results were reported for deamidated gliadin peptide antibodies (DGP) IgA tests (sensitivity = 87.8%; specificity = 94.1%) in a recent meta-analysis. Evidence for algorithms using multiple tests was insufficient because of diverse results, low number of studies, and heterogeneity of populations. Evidence was also insufficient for accuracy in asymptomatic general population screening and special populations such as children and patients with type 1 diabetes, anemia, and IgA deficiency.


New evidence on accuracy of tests used to diagnose celiac disease supports the excellent sensitivity of tTG IgA tests and excellent specificity of both tTG IgA and EmA IgA tests. Sensitivity of DGP IgA and immunoglobulin G tests is slightly less than for tTG IgA. Additional studies are needed to confirm the accuracy of diagnostic tests in special populations and to validate promising algorithms.


Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1. Contract No. 290-2012-00006-I. Prepared by: Southern California Evidence-Based Practice Center, Santa Monica, CA

Suggested citation:

Maglione MA, Okunogbe A, Ewing B, Grant S, Newberry SJ, Motala A, Shanman R, Mejia N, Arifkhanova A, Shekelle P, Harmon G. Diagnosis of Celiac Disease. Comparative Effectiveness Review No. 162. (Prepared by the Southern California Evidence-based Practice Center under Contract No. 290-2012-00006-I.) AHRQ Publication No. 15(16)-EHC032-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2016.

This report is based on research conducted by the Southern California Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00006-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at Search on the title of the report.


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Bookshelf ID: NBK344454PMID: 26937544


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