血清乙型肝炎核心相关抗原阴性正常参考值的探讨

目的 探讨血清HBcrAg合理的阴性正常参考值。方法 初治的乙型肝炎患者230例和非乙型肝炎患者52例入选本研究。血清HBcrAg采用化学发光酶免疫法和Fujirebio Lumipulse G1200全自动化学发光免疫系统检测。数据处理和统计分析采用SPSS 16.0软件。结果血清HBcrAg呈非正态分布(P＜0.01)。HBsAg阳性患者血清HBcrAg与HBV DNA呈显著正相关(P＜0.01)。血清HBcrAg诊断HBsAg阳性患者的ROC曲线下面积(0.953)显著大于对角参考线下面积(P＜0.01)。当血清HBcrAg≥1500U/ml、≥1250U/ml、≥1000U/ml、≥750U/ml、≥500U/ml时,其诊断HBsAg阳性患者的灵敏度和特异度分别为0.865和0.981、0.865和0.962、0.870和0.923、0.896和0.904、0.909和0.885。结论 血清HBcrAg＜1000U/ml可能是合理的阴性正常参考值。
Objective To explore the rational negative normal reference value of serum hepatitis B core-related antigen(HBcrAg). Methods Two hundred and thirty patients with Nave hepatitis B and 52 non- hepatitis B patients were enrolled in the study. Serum HBcrAg levels were measured by Fujirebio Lumipulse G1200 automatic chemiluminescence immunoassay system. SPSS 16.0 software was used for data processes and statistical analyses. Results Serum HBcrAg values were non-normal distribution(P<0.01). Serum HBcrAg values were positively correlated with HBV DNA in HBsAg-positive patents(P<0.01). The area under ROC curve of serum HBcrAg in the diagnosis of HBsAg-positive patients was 0.953. When the cut-off values of serum HBcrAg were taken as 1500U/ml, 1250U/ml, 1000U/ml, 750U/ml, 500U/ml, the sensitivity and specificity in diagnosis of HBsAg-positive patients were 0.865 and 0.981,0.865 and 0.962,0.870 and 0.923,0.896 and 0.904,0.909 and 0.885. Conclusion Serum HBcrAg<1000U/ml may be the reasonable negative normal reference value