两种不同方法检测乙型肝炎病毒感染血清学标志物的对比

Comparison of two different methods for detection of serological markers of hepatitis B virus infection

目的探讨化学发光免疫分析法(CLIA)与酶联免疫吸附试验法(ELISA)在检测乙型肝炎病毒(HBV)感染血清学标志物中的应用价值。方法选取90例洛阳市中心医院2019年8月—2021年8月就诊的HBV感染患者作为研究组,另选取同期90例健康体检人群作为参照组,入院后分别采集血清样本采用CLIA、ELISA法对乙肝五项[乙肝表面抗原(HBsAg)、乙肝e抗原(HBeAg)、乙肝e抗体(HBeAb)、乙肝表面抗体(HBsAb)、乙肝核心抗体(HBcAb)]进行检测,比较两种检测方法单独、联合检查阳性检出率及诊断效能,并比较其对于低水平HBsAg检测结果。结果与CLIA法、ELISA法单独检查比较,二者联合应用对研究组HBsAg、HBeAb、HBcAb阳性检出率分别为78.89%、35.56%、83.33%,高于单独检查(P<0.05);与CLIA法、ELISA法单独检查比较,二者联合应用对于HBsAg诊断灵敏度78.89%、准确率88.89%较高,漏诊率21.11%较低(P<0.05);与ELISA法比较,CLIA法对HBsAg水平0.06~0.10 IU/mL及0.11~0.50 IU/mL检出率较高(P<0.05);ELISA法检测最低HBsAg浓度为0.93 IU/mL,CLIA法检测最低HBsAg浓度为0.03 IU/mL。结论CLIA法检测HBV病毒感染血清学标志物优于ELISA法,可有效提高阳性检出率,二者联合应用能显著提高诊断效能,为临床早期筛查诊断、针对性制定个体化治疗方案提供可靠依据。

Objective To investigate the value of chemiluminescent immunoassay(CLIA)and enzyme-linked immunosorbent assay(ELISA)method in the detection of serological markers of hepatitis B virus(HBV)infection.Methods Ninety patients with HBV infection attending our hospital from August 2019 to August 2021 were selected as the study group,and another 90 patients with healthy physical examination in the same period were selected as the reference group.After admission,serum samples were collected by CLIA and ELISA for the five hepatitis B items[hepatitis B surface antigen(HBsAg),hepatitis B e antigen(HBeAg),hepatitis B e antibody(HBeAb)],hepatitis B surface antibody,hepatitis B core antibody.The results were compared with the positive detection rate and diagnostic efficacy of the two tests alone and in combination,and their results were compared for low level HBsAg detection.Results Compared with the CLIA method and ELISA method alone,the detection rates of HBsAg,HBeAb and HBcAb positivity in the study group were 78.89%,35.56% and 83.33%,respectively,which were higher than those of the CLIA method and ELISA method alone(P<0.05).Compared with the CLIA method and ELISA method alone,the combination of the two had a higher sensitivity of 78.89% and a higher accuracy of 88.89% for the diagnosis of HBsAg,and a lower leakage rate of 21.11%(P<0.05).Detection rate of HBsAg levels 0.06-0.10 IU/mL and 0.11-0.50 IU/mL by CLIA method were higher compared with ELISA method(P<0.05).The lowest HBsAg concentration detected by ELISA was 0.93 IU/mL and the lowest HBsAg concentration detected by CLIA was 0.03 IU/mL.Conclusion CLIA method is superior to ELISA method in detecting serological markers of HBV infection,which can effectively improve the positive detection rate,and the combined application of the two can significantly improve the diagnostic efficacy and provide a reliable basis for early clinical screening and diagnosis and targeted individualized treatment plan.