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目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的抗乙肝病毒e抗原抗体(Antibody to Hepatitis B Viruse Antigen,Anti-HBe)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免疫测定法Anti-HBe检测试剂,平行检测由66份阳性和86份阴性品组成的参比系统各5次,将每个检测的co/s值(诊断试验截断值与样品速率值之比)做log(co/s+1)转换,计算并比较各试剂的可靠性指标组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Vaviability,CV)和真实性指标曲线下面积(Area Under Curve,AUC)、部分(partial)AUC(pAUC)、固定特异度下的灵敏度[Sensitivity at a Particular False-Positive-Rate,Se(FPR=e)]等。结果五种试剂ICC、CV从优到劣的排序均为A、E、C、D、B,ICC除试剂C与E外,其他试剂间差异均有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.969～0.996,pAUC从大到小的排序为C、E、D、A、B,且试剂C明显高于试剂A、B、D、E(Bootstrap法,P<0.05);Se(FPR=e)排序为C、D、E、B、A,试剂C明显高于其他四种试剂(Bootstrap法,P<0.05)。结论五种符合国家质量标准的试剂诊断性能均好,其中试剂C为最佳。
Objective To investigate the serological epidemiology of hepatitis B virus (HBV) in the whole Chinese population and screen out the appropriate Antibody to Hepatitis B Viruse Antigen (Anti-HBe) detection reagent. Methods Five anti-HBe reagents, which meet the national quality standards and were the most widely sold in the country, were used to detect anti-HBe reagent, which consisted of 66 positive samples and 86 negative samples. (Co / s + 1) conversion for each test co / s value (ratio of diagnostic test cut-off value to sample rate value), calculate and compare the relative reliability of each reagent group within the group (ICC), coefficient of variation (CV) and area under curve (AUC), partial AUC (pAUC), sensitivity at a fixed specificity [Sensitivity at a Particular False-Positive-Rate, Se (FPR = e)] and the like. Results The rankings of ICC and CV of five kinds of reagents were A, E, C, D and B, respectively. There were significant differences among the other reagents except for Reagents C and E in ICC (Bootstrap method, P <0.05). The AUCs of the five reagents ranged from 0.969 to 0.996, and the order of the pAUCs was C, E, D, A and B. The reagent C was significantly higher than the reagents A, B, D and E (Bootstrap method, P <0.05 ); Se (FPR = e) was ranked as C, D, E, B, A, and reagent C was significantly higher than the other four reagents (Bootstrap method, P <0.05). Conclusion The five reagents that meet the national quality standards have good diagnostic performance, of which reagent C is the best.