电化学发光免疫法和酶联免疫法检测乙肝病毒标志物结果准确性的比较

施振岗

[摘要]目的 分析比较电化学发光免疫法（ECLIA）和酶联免疫法（ELISA）检测乙型病毒性肝炎（HBV）标志物检测结果的准确性。方法 选取2015年1月～2017年1月在我院就诊的160例乙型肝炎患者，随机分为观察组（80例）和对照组（80例）。观察组使用ECLIA法，对照组使用ELISA法，比较两组的HBV标志物阳性率，再在观察组中选取HBsAg/Ab和（或）HBeAg/Ab双阳性的患者，采用ELISA法检测，观察其检测结果。结果 观察组的HBsAg、HBsAb、HBeAg、HBeAb阳性率分别为100.0%、52.5%、76.3%、78.8%，均高于对照组的92.5%、45.2%、52.5%、50.0%，差异有统计学意义（P<0.05）；ECLIA法对s和（或）e系统双阳性的患者检出76例，相比之下，ELISA法只检出9例。结论 ECLIA法检测乙肝病毒感染的结果较ELISA法更准确，值得临床推广应用。

[关键词]电化学发光免疫法；酶联免疫法；乙型病毒性肝炎

[中图分类号] R512.6+2 [文献标识码] A [文章编号] 1674-4721（2017）06（c）-0111-03

[Abstract]Objective To analyze and compare the accuracy of electrochemiluminescence immunoassay （ECLIA） and enzyme-linked immunosorbent assay （ELISA） in the detection of hepatitis B virus （HBV） markers.Methods 160 patients with HBV treated in our hospital from January 2015 and January 2017 were selected as research targets，and were randomly divided into the observation group （n=80） and the control group （n=80）.The observation group was given ECLIA and the control group was given ELISA，the positive rates of HBV markers were compared between the two groups.Then in the observation group，HBsAg/Ab and/or HBeAg/Ab double positive patients were selected and detected by ELISA method，and the results were observed.Results The positive rates of HBsAg，HBsAb，HBeAg and HBeAb in the observation group were 100.0%，52.5%，76.3% and 78.8% respectively，which was higher than 92.5%，45.2%，52.5%，50.0% in the control group，with significant difference （P<0.05）.The number of patients with the s and/or e system double positive detection results by the method of ECLIA were 76 cases，but the number by the method of ELISA were comparatively 9 cases.Conclusion Compared with ELISA，ECLIA is more accurate in the detection of HBV infection，therefore，it is worthy of wide clinical promotion and application.

[Key words]Electrochemiluminescence immunoassay；Enzyme-linked immunosorbent assay；Hepatitis B virus

我國的乙型肝炎发病率较高，约有12%为平时无自觉症状的乙肝病毒表面抗原（HBsAg）携带者[1]，乙肝感染者如不及时治疗，可发展为肝炎、肝硬化、肝癌等重大疾病[2]，因而准确地诊断乙肝病毒（HBV）标志物，选取敏感度和特异度高的检测方法，对及时防治乙肝有着重要的意义。以前在临床多采取酶联免疫吸附法（ELISA）检测乙肝的5项病毒标志物，即检测HBsAg、乙肝表面抗体（HBsAb）、乙肝e抗原（HBeAg）、乙肝e抗体（HBeAb）和乙肝核心抗体（HBcAb）来判断患者的病情及治疗效果；但其仅为定性分析，对患者病情和疗效的动态监测效果不甚理想，比如在样本HBsAg浓度过高时的假阴性和浓度过低时因灵敏度差而漏诊，对于复杂感染的乙肝患者还会出现误诊[3]。目前的电化学发光免疫法（ECLIA法）因其操作使用方便，快速，灵敏度和特异性均较为理想等优势被逐渐应用于临床。研究显示，ECLIA检测HBV感染的灵敏度已超过放射免疫的水平。……