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  • 简介:[摘要 ] 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 2017年 1月~ 2019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法對乙肝的诊断结果。 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 HBsAg、 HBeAg、 HBeAb的阳性检出率高于 ELISA法( P<0.05),而在 HBsAb、 HBcAb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。     [关键词 ] 乙型肝炎;乙肝病毒;血清学检验;化学发光免疫分析法;酶联免疫吸附试验     [Abstract] 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 2017 to June 2019, 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 HBsAg, HBeAg and HBeAb by CLIA was higher than that of ELISA( P<0.05), and the difference of positive detection rate of HBsAb and HBcAb 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.     [Key words] Hepatitis B; Hepatitis B virus; Serological testing; Chemiluminescence immunoassay( CLIA); Enzyme-linked immunosorbent assay( ELISA)

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