Abstract

In coeliac disease, the diagnostic work-up is based on a combination of clinical, histopathological and serological evaluation. Among the serological tests, the presence of tissue transglutaminase (tTG) IgA antibodies is the cornerstone owed to a high sensitivity and specificity. Recently, Immunodiagnostic Systems Ltd (IDS) introduced the fully automated chemiluminescent autoimmune assays for use on the IDS-iSYS Multi-Discipline Automated System. In this study, we aimed to compare the performance of the IDS-iSYS assay to the Thermo Fisher Phadia assay and to establish the upper reference limit of tTG IgA in a healthy population from Denmark based on the IDS-iSYS assay. We discovered a total imprecision of CV = 12.2% (2.87 AU/mL) and CV = 10.6% (47.55 AU/mL). Moreover, we compared the performance of IDS-iSYS assay to Thermo Fisher Phadia assay in 236 samples from unselected patients submit for tTG IgA testing and found a concordance of 97% (p < .0001). Furthermore, in 150 healthy blood donors, we established the upper reference limit of 3.26 AU/mL (95% CI: 3.10 − 3.90) was identified. Our study validates the performance of the IDS-iSYS tTG IgA assay and demonstrates results in concordance with the established Thermo Fisher Phadia. Furthermore, it provides estimates for the upper reference interval limit of the tTG-IgA.

摘要

在乳糜泻中，诊断检查基于临床、组织病理学和血清学评估的组合。在血清学检测中，组织转谷氨酰胺酶 (tTG) IgA 抗体的存在是高灵敏度和特异性的基石。最近，Immunodiagnostic Systems Ltd (IDS) 推出了用于 IDS-iSYS 多学科自动化系统的全自动化学发光自身免疫分析。在本研究中，我们旨在比较 IDS-iSYS 检测与 Thermo Fisher Phadia 检测的性能，并基于 IDS-iSYS 检测确定丹麦健康人群中 tTG IgA 的参考上限。我们发现 CV = 12.2% (2.87 AU/mL) 和 CV = 10.6% (47.55 AU/mL) 的总不精确性。而且，p  < .0001）。此外，在 150 名健康献血者中，我们确定了 3.26 AU/mL（95% CI：3.10 - 3.90）的参考上限。我们的研究验证了 IDS-iSYS tTG IgA 检测的性能，并证明结果与既定的 Thermo Fisher Phadia 一致。此外，它还提供了 tTG-IgA 参考区间上限的估计值。