Fabiani E, Catassi C
University of Department of Paediatrics, Ancona, Italy.
Eur J Gastroenterol Hepatol. 2001 Jun;13(6):659-65. doi: 10.1097/00042737-200106000-00008.
So far the reliability of the anti-tissue transglutaminase (anti-tTG) test for the diagnosis of coeliac disease has mostly been evaluated using slightly different enzyme-linked immunosorbent assays (ELISAs) in selected and usually small groups of patients. The aims of this study were: (1) to evaluate the reliability of the IgA anti-tTG antibodies for the diagnosis of coeliac disease; and (2) to define the sensitivity and specificity of a commercially available kit for the anti-tTG antibodies' quantitative determination.
Each centre in this international multi-centre study collected sera from three groups of subjects: coeliac disease patients at the onset of (1) or on a gluten-free diet for at least 12 months (2); disease and healthy controls (3).
The anti-tTG antibodies were determined in duplicate using an ELISA-based commercially available kit (Eu-tTG Eurospital, Trieste, Italy).
The following overall cases and controls have been enrolled: (1) 399 subjects with active coeliac disease; (2) 351 treated coeliac disease cases; (3) 432 controls. The centralized re-testing was performed on: (1) group a: 176 patients with active coeliac disease (mean anti-tTG, 21 arbitrary units [AU]); (2) group b: 172 treated coeliac disease cases (mean anti-tTG, 5 AU); (3) group c: 206 controls (mean anti-tTG, 3 AU). In active coeliacs, the anti-tTG antibodies showed a significant progressive decrease with age, while in controls an opposite trend was found. In active coeliac disease patients, the anti-tTG antibodies were significantly higher in coeliacs with a grade III enteropathy than in those showing a grade II lesion. In treated coeliacs, the mean anti-tTG values were significantly lower in patients strictly adhering to a gluten-free diet than in those reporting dietary transgressions. The sensitivity and the specificity of the Eu-tTG assay were 90% and 96%, respectively.
The results of this study show that the commercially available test for the anti-tTG antibodies' determination is a reproducible and valuable tool for the diagnosis and follow up of coeliac disease.
迄今为止，抗组织转谷氨酰胺酶（抗tTG）检测用于诊断乳糜泻的可靠性大多是在选定的、通常规模较小的患者群体中，使用略有不同的酶联免疫吸附测定（ELISA）进行评估的。本研究的目的是：（1）评估IgA抗tTG抗体用于诊断乳糜泻的可靠性；（2）确定一种市售试剂盒对抗tTG抗体进行定量测定的敏感性和特异性。
在这项国际多中心研究中，每个中心从三组受试者中收集血清：处于疾病发作期（1）或接受无麸质饮食至少12个月的乳糜泻患者（2）；疾病患者和健康对照者（3）。
使用基于ELISA的市售试剂盒（Eu-tTG，意大利的里雅斯特的Eurospital公司）对抗tTG抗体进行双份测定。
共纳入了以下总体病例和对照：（1）399例活动性乳糜泻患者；（2）351例接受治疗的乳糜泻病例；（3）432例对照者。对以下样本进行了集中复测：（1）a组：176例活动性乳糜泻患者（抗tTG平均水平为21个任意单位[AU]）；（2）b组：172例接受治疗的乳糜泻病例（抗tTG平均水平为5 AU）；（3）c组：206例对照者（抗tTG平均水平为3 AU）。在活动性乳糜泻患者中，抗tTG抗体随年龄呈显著的逐渐下降趋势，而在对照者中则发现相反趋势。在活动性乳糜泻患者中，Ⅲ级肠病的乳糜泻患者的抗tTG抗体显著高于Ⅱ级病变患者。在接受治疗的乳糜泻患者中，严格坚持无麸质饮食的患者的抗tTG平均水平显著低于有饮食违规情况的患者。Eu-tTG检测的敏感性和特异性分别为90%和96%。
本研究结果表明，市售的抗tTG抗体检测试剂盒是用于乳糜泻诊断和随访的一种可重复且有价值的工具。
