三种乙型肝炎表面抗原检测方法在口岸体检中的应用评估

Evaluation on three kinds of methods for testing hepatitis B surface antigen for entry-exit people at port

目的循证检验医学(EBLM)指导下,对电化学发光法(ECLIA)、酶联免疫吸附试验(ELISA)、胶体金免疫层析法等3种乙型肝炎表面抗原(HBsAg)检测方法进行评价,为口岸出入境人员寻求最佳的快速HBsAg检测方法和检测程序提供科学依据。方法ECLIA、ELISA、胶体金免疫层析法检测40份(HBsAg)标准血清盘标本,以血清盘预期结果为标准,比较3种方法灵敏度、特异度、总符合率。同时应用成本最小化分析方法,分别计算3种方法的成本。结果在血清盘HBsAg检测中,ECLIA法的灵敏度、特异性和总符合率皆达100.0%,Kappa值为1.000;而ELISA法国产科华试剂灵敏度76.9%、特异性100.0%和总符合率85.0%,Kappa值为0.432;胶体金免疫层析法灵敏度34.6%、特异性100.0%和总符合率57.5%,经Kappa检验其值为0.216。成本最小化分析结果显示:ECLIA法成本20元,ELISA法(科华,国产试剂)成本3元,胶体金免疫层析法成本3元,ECLIA法成本最高。结论ECLIA方法适用于需评估免疫状态,为接种疫苗做准备的出国留学人员、出国商务人员、入境留学生、入境商务人员的HBsAg检测。ELISA国产试剂适用于出国劳务人员、海员等一般人群。胶体金免疫层析法适用于紧急事情人员和日常复查的检测。

Objective To evaluate the diagnostic value of electrochemiluminescence immunoassay（ECLIA）,enzyme linked immunosorbent assay（ELISA） and rapid colloidal gold technique for detecting hepatitis B surface antigen（HBsAg） by the guidance of evidence-based laboratory medicine（EBLM）,and to provide a scientific basis for the selection of method for detecting HBsAg at the ports.Methods HBsAg in serum panel were test by three detection systems of ECLIA,rapid colloidal gold technique and ELISA.The expect result of serum panel was performed as standard,the sensitivity,specificity and coincidence rate of the three methods were compared.The costs of the three methods were calculated by cost minimization analysis method.Results The sensitivity,specificity,the total coincidence rate were 100% by ECLIA,the value was 1.000 by the Kappa test.The sensitivity was 76.9%,specificity was 100%,the total coincidence rate was 85% by ELISA,the value was 0.432 by the Kappa test.The sensitivity was 34.6%,specificity was 100%,the total coincidence rate was 57.5% by rapid colloidal gold technique,the value was 0.216 by the Kappa test.The result of cost minimization analysis method show that the costs of ECLIA,ELISA and rapid colloidal gold technique for detecting HBsAg were 20 RMB/case,3 RMB/case,3 RMB/case.Conclusion ECLIA is suitable for study abroad,business abroad and international students who vaccination status should be assessed.ELISA is suitable for overseas laborers,seamen.Rapid colloidal gold technique is suitable for emergency detection and routine reexamine.