Venugopal Giriprasad, Mechenro John, Makharia Govind, Singh Alka, Pugazhendhi Srinivasan, Balamurugan Ramadass, Ramakrishna Balakrishnan S
SRM Institutes for Medical Science, 1, Jawaharlal Nehru Salai, Vadapalani, Chennai, 600 026, India.
SRM Medical College Hospital and Research Centre, Kattankulathur, India.
Indian J Gastroenterol. 2017 Nov;36(6):481-486. doi: 10.1007/s12664-017-0803-z. Epub 2017 Dec 22.
The diagnosis of celiac disease (CeD) in clinical practice relies on serological testing for IgA antibodies to human tissue transglutaminase (anti-tTG) which diagnose CeD autoimmunity. We compared three kits for their performance in diagnosis of the disease and evaluated the point prevalence of CeD autoimmunity in a South Indian urban population.
In the first part of the study, sera from 90 patients with documented CeD and 92 healthy controls were tested for anti-tTG using three different kits. One thousand nine hundred and seventeen healthy adults residing in urban areas of Vellore and Kancheepuram districts were tested for CeD autoimmunity using a sequential two-test strategy.
The sensitivity, specificity, false positivity, false negativity, positive predictive value, and negative predictive value for the three assays respectively were as follows: 95.5%, 82.6%, 17.3%, 4.4%, 84.3%, and 95% for the Aeskulisa New Generation Assay; 85.5%, 100%, 0%, 14.4%, 100%, and 87.6% for Quanta Lite; and 71.1%, 100%, 0%, 28.8%, 100%, and 71% for Celiac Microlisa. The ROC curves showed good discrimination for all three ELISAs with an AUC of 0.947, 0.950, and 0.886 for the Aeskulisa, Quanta Lite, and Celiac Microlisa, respectively. Of 1917 (males 908, females 1009) healthy adults, 113 (5.89%) were seropositive for IgA anti-htTG in the Aeskulisa test. Two of the latter tested positive in the Quanta Lite assay and/or the Celiac Microlisa assay. The CeD autoimmunity prevalence in this urban population was 1.0 per thousand (95% confidence interval 0.3 to 3.7 per thousand).
Sequential testing for anti-tTG using first a highly sensitive assay followed by a very specific assay is a new strategy for screening for CeD in clinical practice.
临床实践中乳糜泻（CeD）的诊断依赖于检测针对人组织转谷氨酰胺酶的IgA抗体（抗tTG）的血清学检测，该检测用于诊断CeD自身免疫。我们比较了三种试剂盒在该疾病诊断中的性能，并评估了印度南部城市人群中CeD自身免疫的现患率。
在研究的第一部分，使用三种不同的试剂盒对90例确诊CeD的患者和92例健康对照的血清进行抗tTG检测。采用序贯双检测策略，对居住在韦洛尔和金奈普纳姆地区城市的1917名健康成年人进行CeD自身免疫检测。
三种检测方法的敏感性、特异性、假阳性率、假阴性率、阳性预测值和阴性预测值分别如下：Aeskulisa新一代检测法为95.5%、82.6%、17.3%、4.4%、84.3%和95%；Quanta Lite检测法为85.5%、100%、0%、14.4%、100%和87.6%；乳糜泻微酶联免疫吸附测定法为71.1%、100%、0%、28.8%、100%和71%。ROC曲线显示，三种酶联免疫吸附测定法均具有良好的区分度，Aeskulisa、Quanta Lite和乳糜泻微酶联免疫吸附测定法的曲线下面积分别为0.947、0.950和0.886。在1917名（男性908名，女性1009名）健康成年人中，Aeskulisa检测中113人（5.89%）IgA抗htTG血清学呈阳性。其中两人在Quanta Lite检测法和/或乳糜泻微酶联免疫吸附测定法中呈阳性。该城市人群中CeD自身免疫的患病率为千分之一（95%置信区间为千分之0.3至3.7）。
在临床实践中，先使用高敏感性检测方法然后使用高特异性检测方法对抗tTG进行序贯检测是一种筛查CeD的新策略。
