【摘要】 目的:建立两种胶体金反应体系检测柯萨奇病毒B组IgG抗体并进行比较,选出合适的检测方法。方法:利用胶体金标记柯萨奇重组抗原做金标垫,鼠抗人IgG包被做检测线建立捕获法反应体系;利用胶体金标记鼠抗人IgG做金标垫,包被柯萨奇重组抗原做检测线建立间接法反应体系,通过实验选出性能较好的试剂盒并与进口试剂盒(酶联免疫法)进行临床标本比对实验。结果:捕获法同临床已知样本的阳性符合率和阴性符合率分别为97.96%和98.80%,总符合率达到98.67%,间接法同临床已知样本的阳性符合率和阴性符合率分别为93.88%和98.80%,总符合率达到98.00%;在抗干扰实验中,捕获法与间接法对ANA阳性、高脂、黄疸共47例干扰因子样本均有较好的抗干扰性能;但在检测RF阳性样本时,间接法体系研制而成的试剂出现1例假阳性反应;对600例临床样本进行检测,柯萨奇病毒B组IgG抗体捕获胶体金检测试剂与进口试剂盒的阳性符合率和阴性符合率分别为97.82%和99.40%,总符合率达到99.17%。结论:经初步临床应用,表明利用捕获法原理建立的检测试剂盒比利用间接法建立的更灵敏,抗干扰性能更强,而且与进口试剂盒比对,有较高的灵敏度和特异性,具有较好的应用前景。更多还原

【Abstract】 Objective: To establish two kinds of colloidal gold reaction system to detect coxsackievirus B IgG antibody with the appropriate method chosen through comparison.Method: Using the coxsackievirus B recombinant antigen labeled with colloidal gold as the conjugate pad,the test line was packed with the monoclonal antibody to human IgG to build the capture reaction system; Using the monoclonal antibody to human IgG labeled by colloidal gold on the pad,the test line was packed with the recombinant antigen to build the indirect reaction system.Results: The colloidal gold capture kit had a positive coincidence rate of 97.96%,negative coincidence rate of 98.80%,crude consistency of 98.67%;the colloidal gold indirect kit had a positive coincidence rate of 93.88%,negative coincidence rate of 98.80%,crude consistency of 98.00%.In the interference test,testing of 47 serum samples indicated that both of them had good interference ability,only one false positive result occurred using the colloidal gold indirect kit.Testing of 600 serum samples indicated that this colloidal gold capture kit had a sensitivity of 97.82%,specificity of 99.40%,crude consistency of99.17%,compared to the imported CVB-IgG ELISA kit; Conclusion: As can be seen in the pretiminary clinical use,the colloidal gold capture kit has higher sensitivity and more capacity than the indirect one by the experiments.Compared to imported reagents,the colloidal gold capture kit has higher sensitivity and specificity with a good prospects.更多还原