Abstract:

Objective  To explore the performance of the biotin?avidin complex enzyme linked immunosorbent assay of detecting specific IgG4 for the diagnosis of clonorchiasis. Methods  The avidin?biotin complex enzyme linked immunosorbent assay of detecting specific IgG4（IgG4?ABC?ELISA）against Clonorchis sinensis was established，and used to detect the serum samples of patients with clonorchiosis sinensis, schistosomiasis japonica, paragonimiasis, toxoplasmosis, echinococcosis, cysticercosis and sparganosis mansoni. At the same time，these sera were analyzed by the ELISA of detecting IgG4（IgG4?ELISA）and ELISA of detecting the total IgG（IgG?ELISA）as controls. The sensitivity，specificity，positive predictive value（PPV），negative predictive value（NPV）and the respective diagnostic performance of the three methods were compared. Results  The IgG4?ABC?ELISA for diagnosis of clonorchiasis was established successfully. The sensitivity and specificity of the IgG4?ABC?ELISA for detecting clonorchiasis were 90.0% and 98.2% respectively，and PPV and NPV were 93.8% and 97.0% respectively. Its diagnostic performance was 96.3%. The sensitivity and specificity of the IgG4?ELISA for detecting clonorchiasis were 86.0% and 98.2% respectively，and PPV and NPV were 93.5% and 95.9% respectively. Its diagnostic performance was 95.4%. The sensitivity and specificity of the IgG?ELISA for detecting clonorchiasis were 94.0% and 88.1% respectively，and PPV and NPV were 70.1% and 98.0% respectively. Its diagnostic performance was 89.4%. The sensitivity of IgG4?ABC?ELISA was higher than that of IgG4?ELISA（P < 0.05），and the specificity of IgG4?ABC?ELISA was higher than that of IgG?ELISA（P<0.05）. Conclusions IgG4?ABC?ELISA of detecting specific antibody IgG4 against Clonorchis sinensis has high sensitivity and specificity. Therefore，it has a good application value in the diagnosis of clonorchiasis.

Key words: Clonorchis sinensis, Biotin?avidin, Enzyme linked immunosorbent assay（ELISA）, IgG4, IgG, Diagnosis

摘要：

目的  探讨亲和素?生物素复合酶联免疫吸附法（ABC?ELISA）检测特异性IgG4抗体用于诊断华支睾吸虫病的效果。方法  建立检测华支睾吸虫特异性抗体IgG4的ABC?ELISA法（IgG4?ABC?ELISA），以此方法检测华支睾吸虫病、日本血吸虫病、卫氏并殖吸虫病、弓形虫病、棘球蚴病、囊尾蚴病和曼氏裂头蚴病患者血清样本。以IgG4?ELISA和IgG?ELISA法为对照，比较3种方法用于诊断华支睾吸虫病的敏感性、特异性、阳性预测值、阴性预测值及诊断效率。结果  成功建立了用于检测华支睾吸虫特异性抗体的IgG4?ABC?ELISA法，用此方法检测华支睾吸虫病患者血清特异性抗体IgG4的敏感性为90.0%，特异性为98.2%，阳性预测值为93.8%，阴性预测值为97.0%，诊断效率为96.3%；IgG4?ELISA法检测华支睾吸虫病患者血清特异性抗体敏感性为86.0%，特异性为98.2%，阳性预测值为93.5%，阴性预测值为95.9%，诊断效率为95.4%；IgG?ELISA法检测华支睾吸虫病患者血清特异性抗体IgG的敏感性为94.0%，特异性为88.1%，阳性预测值为70.1%，阴性预测值为98.0%，诊断效率为89.4%。IgG4?ABC?ELISA法检测华支睾吸虫病患者血清特异性抗体的敏感性高于IgG4?ELISA法（P < 0.05），特异性高于IgG?ELISA法（P < 0.05）。结论  IgG4?ABC?ELISA法检测华支睾吸虫特异性抗体IgG4具有高度敏感性与特异性，在华支睾吸虫病诊断中具有较好应用价值。

关键词: 华支睾吸虫, 亲和素?生物素, 酶联免疫吸附法, IgG4, IgG, 诊断