| Autor: |
Rolf A. Klaasen, David J. Warren, Rasmus Iversen, Nils Bolstad, Ina L. Andersen, Patricia Mjønes, Elin Rønne, Knut E.A. Lundin, Ludvig M. Sollid, Eivind Ness–Jensen |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Clinical Biochemistry |
| ISSN: |
0009-9120 |
| Popis: |
Background 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. Method 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. Results 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) < 16% and 2.0 mg*/L had celiac disease, and this cut-off identified 88% of newly diagnosed celiac patients. Eight percent (2/26) of the newly diagnosed patients had primarily anti-TG2 IgG. Conclusions In this study we developed and clinically validated a robust and automated assay suitable for celiac disease screening in the general population. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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