化学发光免疫分析技术和酶联免疫吸附试验在乙肝病毒血清学检验中的价值分析

Analysis on the value of chemiluminescence immunoassay and enzyme-linked immunosorbent assay in serological detection of hepatitis B virus

目的比较化学发光免疫分析技术(CLIA)和酶联免疫吸附试验(ELISA)在乙肝病毒血清学检验中的应用价值。方法选取2014年1月~2017年6月间我院收治的80例疑似乙型肝炎患者,采用CLIA法、ELISA法对乙肝病毒血清学指标进行检测,以实时荧光定量PCR检验结果作为参照,分析CLIA法、ELISA法对乙肝的诊断结果。结果 ELISA法对乙肝的诊断灵敏度、特异度、准确性分别为91.84%、93.55%、92.50%,CLIA法分别为93.88%、96.77%、95.00%,二者比较均无统计学差异(P均>0.05)。CLIA法、ELISA法对乙肝的诊断结果与实时荧光定量PCR之间具有良好一致性,Kappa均>0.7。CLIA法对HBs Ag、HBe Ag、HBe Ab的阳性检出率高于ELISA法(P<0.05),而在HBs Ab、HBc Ab阳性检出率比较无统计学差异(P>0.05)。结论 CLIA法、ELISA法对乙型肝炎的诊断效果均较好,而在乙肝病毒血清学标志物检验中,CLIA法的检验准确性高于ELISA法。

Objective To compare the application value of chemiluminescence immunoassay（CLIA） and enzyme-linked immunosorbent assay（ELISA） in serological testing of hepatitis B virus. Methods From January 2014 to June 2017,80 patients with suspected hepatitis B who were admitted to our hospital were selected. CLIA method and ELISA method were used to determine the serological indices of hepatitis B virus. Real-time fluorescence quantitative PCR test results were used as the reference. The diagnosis results of hepatitis B by CLIA method and ELISA method were analyzed. Results The diagnostic sensitivity, specificity and accuracy of ELISA for hepatitis B were 91.84%, 93.55%and 92.50% respectively, and those of CLIA were 93.88%, 96.77%, 95.00% respectively. There was no statistically significant difference between the two methods（P〉0.05 for all）. CLIA method and ELISA method for the diagnostic results of hepatitis B were well consistent with real-time fluorescence quantitative PCR（Kappa〉0.7 for all）. The positive detection rate of HBs Ag, HBe Ag and HBe Ab by CLIA was higher than that of ELISA（P〈0.05）, and the difference of positive detection rate of HBs Ab and HBc Ab was not statistically significant（P〉0.05）. Conclusion CLIA method and ELISA method are favorable for the diagnosis of hepatitis B. In the hepatitis B virus serological marker test, the test accuracy of CLIA is higher than that of ELISA.