乙型肝炎病毒e抗原(hepatitis B e antigen, HBeAg)的定量检测对乙型肝炎临床诊疗具有一定的重要性，但其定量检测还未成为常规检验项目。本研究对HBeAg定量检测系统进行性能验证，比较HBeAg定量和定性检测的相关性和一致性，分析HBeAg定量结果和乙型肝炎病毒DNA(hepatitis B virus DNA, HBV DNA)的关系，为HBeAg定量检测在临床诊疗的应用提供依据。通过收集710例2019年3月至5月于复旦大学附属华山医院就诊的慢性乙型肝炎患者血清样本，参照美国临床实验室标准化协会(The Clinical & Laboratory Standards Institute, CLSI)相关文件的要求，对雅培ARCHITECTi4000SR全自动免疫分析仪检测的HBeAg定量试剂的精密度、分析灵敏度、线性范围/可报告范围、携带污染率进行验证和评价；采用化学发光微粒子免疫检测技术(chemiluminescence microparticle immuno assay, CMIA)对618例患者进行HBeAg定性和定量检测；采用荧光定量PCR对慢性乙型肝炎患者进行HBV DNA检测，比较HBV DNA和HBeAg定量结果的相关性。本研究证实HBeAg定量试剂检测性能验证结果良好；HBeAg定量和定性检测相关性良好；126例同时有HBeAg定量检测和HBV DNA定量检测的结果显示，两种方法呈正相关且一致性良好。HBeAg定量检测可用于常规实验室检测来辅助HBV感染的临床诊疗。

The study validated the relevant performance of the quantitative detection system for hepatitis B e antigen (HBeAg), compared the correlation and consistency between quantitative and qualitative tests of HBeAg, and discussed the relationship between the hepatitis B virus DNA (HBV DNA) and the quantitative analysis of HBeAg, in order to provide the evidence of quantitative analysis of HBeAg in clinical diagnosis. A total of 710 patients with chronic hepatitis B who were treated at Huashan Hospital，Fudan University，from March to May 2019 were collected. According to requirements of Clinical and Laboratory Standards Institute (CLSI), the precision, analytical sensitivity, linear range/reportable range, and carrying contamination rate of the HBeAg quantitative reagent tested on Abbott ARCHITECTi4000SR automated immunoassay analyzer were verified and evaluated. The chemiluminescence microparticle immunoassay (CMIA) was used for qualitative and quantitative detection of HBeAg in 618 patients. Fluorescent quantitative PCR was applied to the quantitative of HBV DNA in patients with chronic hepatitis B, and the correlation between HBV DNA and HBeAg quantitative results was analyzed.This study confirms that HBeAg quantitative reagent test performance verification results were good, and the verified performances was content with the manufacturer’s instructions and the requirements of our laboratory. HBeAg quantitative and qualitative tests had a good correlation. 126 cases who had both HBeAg quantitative detection and HBV DNA test results showed that the two methods had a satisfactory agreement and were positively correlated. HBeAg quantitative tests can be used in routine laboratory testing to assist the clinical diagnosis and treatment of HBV infection.