Objective: To evaluate the effects of 3 kinds of ELISA reagents on the detection of human paragonimiasis.
Methods: A total of 45 serum samples from patients with paragonimiasis, 218 serum samples from patients with other parasitic diseases as well as 80 serum samples from healthy people were detected by GD-ELISA (IgG antigen ELISA detection reagent), ESELISA (using excretory/secretory (ES) products of Paragonimus westermani), and sAg-ELISA (using semi-purified antigen (sAg) of P. westermani), respectively. The effects of the 3 reagents were evaluated and compared.
Results: The sensitivities of GD-ELISA, ES-ELISA, and sAg-ELISA were 95.6% (95% CI：89.6%～100.0%), 93.3% (95% CI：86.0%～100.0%) and 86.7% (95% CI：76.8%～96.6%), respectively; the specificities of the above three reagents were 88.6% (95% CI：85.0%～ 92.2%), 88.9% (95% CI：85.3%～92.5%) and 99.0 % (95% CI：97.9%～100.0%), respectively, and the Youden indexes of them were 0.84, 0.82 and 0.86, respectively.
Conclusions: sAg-ELISA is more suitable than GD-ELISA and ES-ELISA for clinical sample tests in paragonimiasis endemic areas in China.
［摘要］目的 评价3种人体并殖吸虫病ELISA试剂盒的检测效果。方法 采用本研究室卫氏并殖吸虫成虫排泄-分泌 物抗原 (ES) 、成虫可溶性抗原的半纯化抗原 (sAg) 包被的人体并殖吸虫病ELISA试剂盒 (ES-ELISA和sAg-ELISA) 及广 东某生物公司生产的并殖吸虫IgG抗体检测试剂盒 (GD-ELISA), 分别检测45份并殖吸虫病患者血清、218份其他寄生虫 病患者血清和80份健康人血清, 评价3种检测试剂盒的检测效果。结果 GD-ELISA、ES-ELISA和sAg-ELISA 3种试剂 盒检测的敏感性分别为95.6 % (95% CI：89.6%～100.0%) 、93.3 % (95% CI：86.0%～100.0%) 和86.7 % (95% CI： 76.8%～96.6%), 特异性分别为88.6% (95% CI：85.0%～92.2%) 、88.9% (95% CI：85.3%～92.5%) 和99.0 % (95% CI： 97.9%～100.0%), 约登指数分别为0.84、0.82和0.86。 结论 sAg-ELISA试剂盒检测效果较好, 比GD-ELISA和ES-ELISA 两法更适用于我国并殖吸虫病临床样本的复核检测。.
Keywords: Effect evaluation; Enzyme-linked immunosorbent assay (ELISA); Paragonimiasis; Paragonimus westermani; Sensitivity; Specificity; Youden index.