Diagnostic Accuracy of IgA Anti-transglutaminase Antibodies Measured by CLIA for Predicting Villous Atrophy in Coeliac Disease

NCT07364461 | Completed

• 1 other identifier: P/23-168
• Study Type: observational
• Target: 765
• Locations: 1 country
• Sites: 1

Brief Summary

Celiac disease (CD) is an autoimmune disorder in which ingestion of gluten leads to immune-mediated damage of the small intestine. Diagnosis has traditionally required histological confirmation of duodenal villous atrophy. Since 2012, European guidelines have allowed a biopsy-free diagnosis in paediatric patients with IgA anti-tissue transglutaminase 2 antibodies (TGA) levels greater than 10 times the upper limit of normal (\>10 × ULN). In 2025, the diagnostic guidelines for adult CD included the possibility of biopsy-free diagnosis in patients younger than 45 years presenting TGA \>10 × ULN, confirmed in a second serum sample. In both paediatric and adult guidelines, the supporting evidence was based almost exclusively on enzyme immunoassays (EIA) using chromogenic substrates such as ELISA or fluorogenic substrates such as FEIA. In recent years, chemiluminescence immunoassays (CLIA) have largely replaced EIA in routine clinical practice. However, the optimal threshold for CD screening and for biopsy-free diagnosis using CLIA remains unclear, and the few available studies suggest values substantially higher than those established for EIA. Differences in analytical performance, wide variability in cut-off values, potential sex differences and limited real-world data raise concerns about the direct application of the \>10 × ULN criterion to CLIA assays. The primary aim of this study is to evaluate, in a community setting, the performance of CLIA-based TGA measurement to establish a threshold with high specificity and positive predictive value for duodenal villous atrophy (Marsh 2-3) suitable for biopsy-free CD diagnosis and to evaluate potential age and sex-related differences. The secondary aims are: 1) to determine the optimal cut-off for CD with duodenal atrophy screening; 2) to assess the accuracy of the manufacturer recommended cut-off.

Conditions

Coeliac Disease

Keywords

biopsy-free diagnosis; chemiluminescence immunoassays (CLIA); IgA anti-tissue transglutaminase 2 antibodies (TGA)

Outcome Measures

Primary Outcomes (1)

• Optimal cut-off value of TGA levels measured by CLIA for biopsy-free CD diagnosis

  The optimal TGA cut-off value for CD diagnosis with duodenal atrophy will be determined using the cost function minimization method to achieve positive predictive values and specificities of over 95%

  Baseline

Study Arms (2)

CD patients

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had TGA measured by CLIA within the healthcare area served by the Catlab Clinical Analysis Laboratory, covering a population of 717.181 inhabitants as of 1 January 2024 (IDESCAT). This area includes primary care centres and three community hospitals: University Hospital Mútua Terrassa, University Hospital Consorci Sanitari de Terrassa and Consorci Corporació Sanitària Parc Taulí.

You may qualify if:

• Having undergone duodenal biopsy and a complete CD diagnostic work-up
• Eating a gluten-containing diet

You may not qualify if:

• Having an unsuitable or non-performed duodenal biopsy
• Incomplete clinical data
• Inconclusive diagnostic findings
• Previous diagnosis of CD with duodenal biopsy performed during gluten-free diet (GFD)
• IgA deficiency

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

CatLab AIE

Viladecavalls, Barcelona, 08232, Spain

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 23, 2026
• Study Start: January 1, 2020
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (1)