摘要
目的比较电化学发光免疫分析法(ECLIA)、国产化学发光法和酶联免疫吸附试验(ELISA)3种方法检测低浓度乙型肝炎表面抗原(HBsAg)的结果并进行分析。方法收集采用化学发光微粒子免疫分析法(CMIA)检测的结果在0.05IU/ml<HBs Ag≤10.0 IU/ml之间的388份血清标本和200份HBsAg阴性标本,再分别采用ECLIA法、国产化学发光法和ELISA法3种方法检测。以CMIA法为金标准,对ECLIA法、国产化学发光法和ELISA法的灵敏度、特异度、一致性和相关性进行比较分析。结果 ECLIA法灵敏度高于国产化学发光法和ELISA法,3种方法两两比较,差异均有统计学意义(P<0.05);化学发光法和ELISA法灵敏度比较,差异无统计学意义(P>0.05);ECLIA法、ELISA法和化学发光法检测结果特异度均较高,3种方法两两比较,差异无统计学意义(P>0.05);ECLIA法与CMIA法相比,低浓度HBsAg测定结果一致性较好(Kappa值为0.99);化学发光法和ELISA法与CMIA法相比,低浓度HBsAg测定结果一致性不理想(Kappa值分别为0.42和0.39);ECLIA法与CMIA法低浓度HBs Ag测定结果相关性良好(R≥0.95),国产化学发光法和ELISA法与CMIA法低浓度HBsAg测定结果相关性一般(R值分别为0.766和0.743)。结论 ECLIA法与CMIA法对低浓度HBsAg的检出灵敏度、特异度、一致性和相关性均较好,国产化学发光法对低浓度HBsAg的检出灵敏度、一致性和相关性低于CMIA法和ECLIA法,与ELISA法敏感度相似;国产化学发光法对低浓度HBsAg的检测需要改进。
Objective To compare and ana1yze the detecting resu1ts of 1ow concentrations of hepatitis B surface antigen（HBsAg）by ECLIA,domestic chemi1uminescence method and ELISA. Methods Tota11y 388 serum samp1es of 0. 05 IU/ m1 〈 HBsAg≤10. 0 IU/m1 and the 200 serum samp1es of HBsAg negative which were detected by CMIA were co11ected. Then those serum samp1es were detec-ted by ECLIA,domestic chemi1uminescence method and ELISA,CMIA as standard. The sensitivity,specificity,consistency and re1ativi-ty of these three detecting methods were compared and ana1yzed. Results The sensitivity of ECLIA was higher than domestic chemi1u-minescence method and ELISA which was of significance（ P 〈 0. 05）;the difference in sensitivity of domestic chemi1uminescence method and ELISA was no significance（ P 〉 0. 05）;the difference in specificity of these three methods was no significance（ P 〉0. 05）. The detecting resu1ts of HBsAg by ECLIA were in good consistency（Kappa = 0. 99）with CMIA,whi1e,in poor consistency by domestic chemi1uminescence method and ELISA（Kappa were 0. 42 and 0. 39）. The detecting resu1ts of HBsAg by ECLIA were in good re1ativity with CMIA,whi1e,in poor re1ativity by domestic chemi1uminescence method and ELISA（R were 0. 766 and 0. 743）. Conclu-sion The sensitivity,specificity,consistency and re1ativity of ECLIA and CMIA were a11 good in detecting 1ow concentrations of hepa-titis B surface antigen,whi1e,higher than domestic chemi1uminescence method and ELISA in sensitivity,consistency and re1ativity;and the domestic chemi1uminescence method need to be improved.
出处
《临床军医杂志》
CAS
2015年第12期1268-1270,共3页
Clinical Journal of Medical Officers
关键词
低浓度HBsAg
微粒子化学发光免疫分析法
电化学发光法
化学发光法
酶联免疫吸附试验
Low concentration of HBsAg
Microparticle chemiluminescent immunoassay
Electrochemical luminescence immu-noassay
Chemiluminescence method
Enzyme linked immunosorbent assay
