Department of Infectious, Parasitic and Immunomediated Diseases, Istituto Superiore di Sanità, Rome, Italy.
PLoS One. 2013 May 9;8(5):e62267. doi: 10.1371/journal.pone.0062267. Print 2013.
Since opisthorchiasis does not show pathognomonic signs or symptoms, physicians can have serious problems to make a differential diagnosis of this infection in non endemic areas, in particular when there is a simultaneous occurrence with other seasonal infections. Moreover, symptomatic infections due to O. felineus can last a few weeks and then the signs and symptoms disappear, but the worms survive in the bile ducts for years causing hepatobiliary diseases including hepatomegaly, cholangitis, fibrosis of the periportal system, cholecystitis, and gallstones. Consequently, an early diagnosis prevents chronicity and loss of working days. The detection of specific antibodies has been considered as a complementary tool to the fecal examination to establish the definitive diagnosis of this infection and for the follow up. Therefore the aim of this work was the development and validation of an enzyme-linked immunosorbent assay (ELISA) using excretory/secretory antigens (ESA) from O. felineus adult worms to detect anti-Opisthorchis IgG in human sera. A total of 370 human sera were tested: 144 sera from persons with a confirmed diagnosis of opisthorchiasis, 110 sera from healthy Italian people, and 116 sera from people with other parasitic or non-parasitic infections. Results were analyzed by receiver-operator characteristic (ROC) curve analysis. The accuracy of the test, calculated by the area under curve (AUC), yielded a 0.999 value, indicating the high performance of the test. The sensitivity was 100% (95% CI: 97.40% to 100%) and no false-negative sera were detected; the specificity was 99.09% (95% CI: 95.02% to 99.83%). The validated ELISA shows a good performance in terms of sensitivity, repeatability and reproducibility, and it is suitable to detect anti-Opisthorchis IgG in human sera for diagnostic purposes and for the follow up to assess the efficacy of drug treatment.
由于华支睾吸虫病没有特征性的体征或症状，医生在非流行地区对这种感染进行鉴别诊断可能会有严重的问题，特别是当同时发生其他季节性感染时。此外，由于 O. felineus 引起的有症状感染可能持续数周，然后体征和症状消失，但蠕虫在胆管中存活数年，导致肝胆疾病，包括肝肿大、胆管炎、门脉周围系统纤维化、胆囊炎和胆结石。因此，早期诊断可防止疾病慢性化和工作日损失。检测特异性抗体已被认为是粪便检查的补充工具，以确立这种感染的明确诊断，并进行随访。因此，这项工作的目的是开发和验证一种酶联免疫吸附试验（ELISA），使用 O. felineus 成虫的排泄/分泌抗原（ESA）来检测人血清中的抗华支睾吸虫 IgG。共检测了 370 个人血清：144 份来自已确诊为华支睾吸虫病的患者，110 份来自意大利健康人群，116 份来自其他寄生虫或非寄生虫感染的患者。结果通过接收者操作特征（ROC）曲线分析进行分析。通过曲线下面积（AUC）计算得出的测试准确性为 0.999，表明测试性能很高。敏感性为 100%（95%置信区间：97.40%至 100%），未检测到假阴性血清；特异性为 99.09%（95%置信区间：95.02%至 99.83%）。验证的 ELISA 在敏感性、可重复性和再现性方面表现良好，适用于检测人血清中的抗华支睾吸虫 IgG，用于诊断目的和随访，以评估药物治疗的效果。
