The development and validation of a high-capacity serological assay for celiac disease

• Published in: Clinical biochemistry 2022-09, Vol.107, p.13-18
• Main Authors: Klaasen, Rolf A., Warren, David J., Iversen, Rasmus, Bolstad, Nils, Andersen, Ina L., Mjønes, Patricia, Rønne, Elin, Lundin, Knut E.A., Sollid, Ludvig M., Ness–Jensen, Eivind
• Format: Article
• Language: English
• Subjects: Anti-TG2; Assay validation; Automation; Celiac disease; Population screening
• ISSN: 0009-9120; 1873-2933
• DOI: 10.1016/j.clinbiochem.2022.05.010

•A high capacity anti-transglutaminase 2 IgA and IgG assay is possible.•Anti-transglutaminase 2 IgA and IgG could be used in population screening.•Anti-transglutaminase 2 IgA levels correlates with disease severity. The aim of the present study was to develop and clinically validate a high-throughput assay for serum IgA and IgG antibodies against transglutaminase-2 (TG2) and to determine appropriate assay cut-offs for large-scale population screening for celiac disease. An automated method was developed using dual label time-resolved fluorometry on the AutoDELFIA platform. Individuals (n = 1920) from the general population were screened. Subjects with serum anti-TG2 concentrations above a preliminary cut-off (>0.3 mg*/L anti-TG2 IgA or >0.5 mg*/L anti-TG2 IgG) were offered endoscopic examination and biopsy. A diagnosis of celiac disease was given if villous atrophy (Marsh grade 3) was found. The assay had a limit of quantification of 0.25 mg*/L (anti-TG2 IgA) and 0.60 mg*/L (anti-TG2 IgG) with imprecision (CV)