电化学发光免疫试验和酶联免疫吸附试验检测乙型肝炎表面抗体比较

Comparison of electro-chemiluminescence immunoassay and enzyme linked immunosorbent assay in hepatitis B surface antibody detection

目的探讨电化学发光免疫试验(ECLIA)和酶联免疫吸附试验(ELISA)测定乙型肝炎(乙肝)表面抗体(HBsAb)的一致率。方法收集陕西省2个县2018年乙肝研究项目2-61岁人群剩余血清,采用ECLIA和ELISA检测HBsAb,分析两种检测结果一致率。结果共检测668例研究对象血清标本,ECLIA和ELISA检测HBsAb均阳性496例、均阴性127例,一致率为93.26%(Kappa=0.807);检测阳性率分别为79.64%(532例)、75.60%(505例)(χ^(2)=440.94,P=0.000)。ECLIA检测HBsAb浓度为2-49IU/L、<2IU/L或≥100IU/L时,ELISA与ECLIA的结果一致率分别为83.33%、≥97.87%。在乙肝疫苗全程免疫后30-45d、1-3年、4-6年、7-10年、>10年的标本中,两种检测的结果一致率分别为98.60%、85.71%、85.19%、93.65%、91.80%。结论 ECLIA和ELISA检测血清HBsAb的结果相似,ECLIA检测敏感性高于ELISA。

Objective To explore the concordance of electro-chemiluminescence immunoassay(ECLIA) and enzyme linked immunosorbent assay(ELISA) in hepatitis B surface antibody(HBsAb) detection.Methods We collected residual serum samples from 2-61-year-olds from 2 counties of Shaanxi province from a 2018 hepatitis B research project. We tested sera for HBsAb using both ECLIA and ELISA to determine concordance.Results A total of 668 serum samples were tested;496 were positive to and 127 were negative to HBsAb for both ECLIA and ELISA, for a concordance of 93.26%(Kappa=0.807). The positivity rate was 79.64%(532 samples) for ECLIA and 75.60%(505 samples) for ELISA(χ^(2)=440.94, P=0.000). Concordance rates of ELISA and ECLIA were 83.33% and ≥97.87% for HBsAb detection concentrations of 2-49 IU/L and <2/≥100 IU/L, respectively. Concordances of the two method were 98.60%, 85.71%, 85.19%, 93.65%, and 91.80% among samples obtained 30-45 days, 1-3 years, 4-6 years, 7-10 years, and >10 years after full-series hepatitis B vaccination.Conclusions ECLIA and ELISA showed similar result for serum HBsAb detection. ECLIA was more sensitive than ELISA.