Multicenter study to compare the diagnostic performance of CLIA vs. FEIA transglutaminase IgA assays for the diagnosis of celiac disease

Daan A. R. Castelijn*, A. H. Leontine Mulder, Pieter van der Pol, Jolien C. Hollander, Tietie Kuiper, Caroline Bijnens, Jan Damoiseaux, Hetty J. Bontkes

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Celiac disease (CD) is an immune-mediated enteropathy driven by gluten intake. Presence of tTG-IgA antibodies is important for the diagnosis. However, different tTG-IgA assays are used and test performance may vary. Therefore, a retrospective multicenter study was performed to compare the diagnostic performance of three assays. The fluorescence enzyme-linked immunoassay (FEIA) EliA Celikey IgA (Phadia), the chemiluminescence immunoassays (CLIA) h-tTG IgA QUANTA Flash®(Inova Diagnostics) and the anti-tTG ChLIA IgA (Euroimmun) were compared. Diagnostic samples from CD cases (95 adults; 65 children) and controls (479 adults; 253 children) were included. Samples were blinded and reanalyzed on all platforms. A high quantitative correlation between platforms was found (p<0.0001). Both CLIA were more sensitive (adults 100%; children 100%) compared to the FEIA (adults 88.4%; children 96.6%). Specificity of all assays was high (≥97.6%) with the FEIA having the highest specificity. A cut-off based on receiver operator characteristic analysis (6.5 U/mL) improved the sensitivity of the FEIA (adults 95.8%; children 100%) without affecting specificity. Cut-off values for the CLIA assays did not need further optimization. With the FEIA, 71% of pediatric cases had a tTG-IgA level ≥10× upper limit of normal compared to 91 and 92% with QUANTA Flash and ChLIA, respectively. All platforms have high diagnostic accuracy. The CLIA assays are more sensitive compared to the FEIA assay. A lower cut-off for the FEIA improves diagnostic performance, particularly in adult cases that, as demonstrated in this study, present with lower tTG-IgA levels compared to pediatric cases.

Original languageEnglish
JournalClinical Chemistry and Laboratory Medicine
Early online date2023
Publication statusE-pub ahead of print - 2023

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