乙型肝炎表面抗体不同检测方法的比较与评价

Comparison and evaluation of various methods for determination of hepatitis B surface antibody

目的采用电化学发光免疫分析法(electrochemiluminescence immunoassay,ECLIA)和酶联免疫吸附法(enzymelinked immunosorbent assay,ELISA)对乙型肝炎表面抗体(hepatitis B surface antibody,HBsAb)进行检测,对比分析两种检测方法的应用效果。方法选取955份广西壮族自治区柳州市已按国家免疫规划要求按时接种乙型肝炎疫苗(hepatitis B vaccine,HepB)的血清样本,分别采用ECLIA法和ELISA法检测HBsAb水平,检测前先对两种方法进行精确度、正确度和可报告范围(线性评价)验证,比较两种方法检测结果的差异。结果两种检测方法的精确度、正确度和可报告范围(线性评价)的验证结果均在可接受范围内。对于血清样本,两种检测方法的定性检测结果具有较强的一致性(Kappa系数为0.7878),而定量检测结果一致性较差(P<0.001)。结论在HBsAb定性检测上,两种方法检测结果无明显差异,但定量检测上却存在明显差异,ELISA法对于低水平抗体检测灵敏度不足,易造成检测结果为假阴性,而ECLIA法灵敏度更高、假阴性率更低、检测结果更可靠。

Objective To determine hepatiits B surface antibody(HBsAb)by electrochemiluminescence immunoassay(ECLIA)and enzyme-linked immunosorbent assay(ELISA)and compare the application effectiveness.Methods A total of 955 serum samples were collected from the subjects immunized with hepatitis B(HepB)vaccine on time according to the requirements in National Immunization Program in Liuzhou City,Guangxi Zhuang Autonomous Region,China,and determined for HBsAb by ECLIA and ELISA respectively.The accuracy,correctness and reportable range(linearity evaluation)of the two methods were verified before determination,and the differences between the results were compared.Results The verification results of precision,correctness and reportable range of the two methods were within the acceptable limits.The qualitative determination results of serum samples by the two methods were in a strong agreement(with a Kappa coefficient of 0.7878),while the quantitative determination results were in poor agreement(P<0.001).Conclusion ECLIA and ELISA showed no significant difference in the qualitative determination while showed significant difference in quantitative determination of HBsAb.The low sensitivity of ELISA for low-level antibody may result in false-negative result,while ECLIA is more sensitive,resulting in a lower false-negative rate and a more reliable result.