Necessity of harmonization of tissue transglutaminase IgA assays to align clinical decision making in coeliac disease

Nevejan, Louis; Dobbels, Pieter; Norman, Gary L.; Voreck, Anja; Bossuyt, Xavier; Hoovels, Lieve Van

doi:10.1515/cclm-2021-1207

Cited by 2 publications

(1 citation statement)

References 9 publications

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“…They suggest that CLIA is more sensitive and accurate than ELISA since after careful evaluation of GFD of persistent positive patients by dieticians the majority of patients recovered. Nevejan et al [20] also evaluated ELIA and CLIA in a small longitudinal cohort of thirteen patients and concluded that the assays would behave identically if stratified cut-offs for the same specificity level were used. Using the manufacturer's cut-off resulted in longer time to normalize for the CLIA assay.…”

Section: Discussionmentioning

confidence: 99%

Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays

Mulder,

Castelijn,

van der Pol

et al. 2023

Clinical Chemistry and Laboratory Medicine (CCLM)

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Objectives Tissue transglutaminase (tTG) IgA antibodies are a hallmark for celiac disease (CD). In CD patients on gluten free diet (GFD) these antibodies are transient. Few studies are available comparing the tTG-IgA assay characteristics for monitoring response to GFD. Since discrepant results were reported in patients on GFD after switching tTG-IgA assays, we conducted a retrospective observational study to monitor GFD response using three different tTG-IgA assays. Methods Diagnostic samples from 44 adults and 17 children with CD were included. Of most patients two follow-up samples after introduction of GFD were available. In all samples tTG-IgA were assessed using one fluorochrome-enzyme immuno-assay (FEIA) and two chemiluminescence immuno-assays (CLIA) and intestinal fatty acid binding protein (i-FABP) as surrogate marker for intestinal epithelial damage was measured. Results Using CLIA assays, normalization of antibody levels was delayed compared to FEIA (p<0.001). Of all samples taken after at least 6 months on GFD with elevated i-FABP indicating intestinal epithelial damage, 40 % had positive tTG-IgA according to the FEIA, 85 and 90 % according to the two CLIA. Conclusions Normalization of tTG-IgA in patients on GFD depends on the assay used. Both CLIA appear to be more sensitive in detecting suboptimal treatment response in CD-indicated by elevated i-FABP – when applying the manufacturer’s recommended cut-off for the diagnosis of CD.

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Section: Discussionmentioning

confidence: 99%

Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays

Mulder,

Castelijn,

van der Pol

et al. 2023

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

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The harmonization issue in laboratory medicine: the commitment of CCLM

Zaninotto

Graziani

Plebani

2022

Clinical Chemistry and Laboratory Medicine (CCLM)

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The analytical quality of the clinical laboratory results has shown a significant improvement over the past decades, thanks to the joint efforts of different stakeholders, while the comparability among the results produced by different laboratories and methods still presents some critical issues. During these years, Clinical Chemistry and Laboratory Medicine (CCLM) published several papers on the harmonization issue over all steps in the Total Testing Process, training an important number of laboratory professionals in evaluating and monitoring all the criticisms inherent to the pre-analytical, as well as analytical and post analytical phases: from the consensus statement on the most informative testing in emergency setting, to the prevention and detection of hemolysis or to patients identification and tube labeling procedures, as far as to different approaches to harmonize hormones measurements or to describe new reference methods or to harmonize the laboratory report. During these years the commitment of the journal, devoted to the harmonization processes has allowed to improve the awareness on the topic and to provide specific instruments to monitor the rate of errors and to improve patients safety.

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Necessity of harmonization of tissue transglutaminase IgA assays to align clinical decision making in coeliac disease

Cited by 2 publications

References 9 publications

Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays

Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays

The harmonization issue in laboratory medicine: the commitment of CCLM

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