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目的探讨电化学发光法(electrochemiluminescence immunoassay,ECLIA)与酶联免疫吸附法(enzyme linked immunosorbent assay,ELISA)及时间分辨荧光分析法(time-resolved fluoroimmunoassay,TRFIA)测定乙型病毒性肝炎(乙肝)血清标志物诊断乙肝的一致性。方法 300例体检及就诊患者,分别采用TRFIA、ECLIA及ELISA检测乙肝表面抗原、乙肝e抗原、乙肝表面抗体、乙肝e抗体、乙肝核心抗体,统计3种方法对乙肝的诊断率,并应用Kappa检验3种方法检测结果的一致性。结果 TRFIA诊断乙肝248例(82.67%),ECLIA诊断257例(85.67%),ELISA诊断251例(83.67%),组间比较差异无统计学意义(P>0.05);Kappa检验结果显示,ECLIA与ELISA(Kappa=0.89,P=0.03)、ECLIA与TRFIA(Kappa=0.94,P=0.01)具有较高一致性。结论 ECLIA与ELISA及TRFIA在检测乙肝血清标志物诊断乙肝上具有较高一致性。
Objective To investigate the diagnostic value of electrochemiluminescence immunoassay (ECLIA) and enzyme linked immunosorbent assay (ELISA) and time-resolved fluoroimmunoassay (TRFIA) Marker diagnosis of hepatitis B consistency. Methods 300 cases of physical examination and treatment of patients, respectively, using TRFIA, ECLIA and ELISA detection of hepatitis B surface antigen, hepatitis B e antigen, hepatitis B surface antibody, hepatitis B e antibody, hepatitis B core antibody, statistics of three methods of hepatitis B diagnostic rate and application of Kappa test 3 ways to test the consistency of the results. Results There were 248 cases (82.67%) diagnosed by TRFIA, 257 cases (85.67%) diagnosed by ECLIA and 251 cases (83.67%) by ELISA. There was no significant difference between the two groups (P> 0.05). Kappa test showed that ECLIA and ELISA (Kappa = 0.89, P = 0.03), ECLIA and TRFIA (Kappa = 0.94, P = 0.01) were highly consistent. Conclusion ECLIA, ELISA and TRFIA have high consistency in the detection of hepatitis B serum markers.