光激化学发光法检测乙型肝炎病毒感染血清学标志的性能评价

目的评价光激化学发光法（LICA）对乙型肝炎病毒（HBV）感染血清学标志的检测性能。方法用乙型肝炎表面抗原（HBsAg）定值血清和质控品对LICA检测HBV感染血清学标志的试验性能进行评价;以化学发光微粒子免疫分析法（CMIA）为比较对象,对LICA检测453例临床样本HBV感染5项血清学标志的结果进行分析。结果 LICA对HBsAg的检测下限（LLD）为0.23 ng/mL,批内的总变异系数（CV）〈5%,平均回收率为99.88%。LICA与CMIA检测HBsAg、乙型肝炎表面抗体（抗HBs）、乙型肝炎e抗原（HBeAg）、乙型肝炎e抗体（抗HBe）的阳性率差异无统计学意义（P〉0.05）,2种方法的符合率〉95%,而LICA检测乙型肝炎核心抗体（抗HBc）阳性率低于CMIA,差异有统计学意义（P〈0.01）。结论 LICA检测HBV感染HBsAg、抗HBs、HBeAg、抗HBe 4项血清学标志具有良好的检测性能,与CMIA有很高的符合率。

Evaluation on analytical performance of light initiated chemiluminescence assay in detecting the serological markers of hepatitis B virus infection

Objective To evaluate the analytical performance of light initiated chemiluminescence assay（LICA） in detecting the serological markers of hepatitis B virus（HBV） infection.Methods The analytical performance was evaluated with quantified sera and quality control materials of HBV surface antigen（HBsAg）,and the methodological comparison was carried out between LICA and chemiluminescent microparticle immunoassay（CMIA） by detecting 5 serological markers of HBV infection in 453 clinical serum samples.Results The lower limit of detection（LLD） was 0.23 ng/mL in detecting HBsAg by LICA,the total within-run coefficient of variation（CV） was 5%,and the average recovery rate was 99.88%.There was no significant difference between LICA and CMIA in the positive detecting rates of HBsAg,antibody to HBsAg（anti-HBs）,hepatitis B e antigen（HBeAg） and antibody to HBeAg B e antigen（anti-HBe）（P0.05） with high consistency rate（95%）.There was a significant difference between LICA and CMIA in the positive detecting rate of antibody to hepatitis B core antigen（anti-HBc）,and the positive rate of anti-HBc by LICA was significantly lower than that by CMIA（P0.01）.Conclusions The LICA possesses satisfied analytical performance in detecting HBsAg,anti-HBs,HBeAg and anti-HBe with high consistency rate compared with CMIA.