摘要
目的:比较化学发光免疫分析(CLIA)法与酶联免疫吸附(ELISA)法在乙型病毒性肝炎(乙肝)诊断中的效能。方法:选取2020年5月至2022年5月该院收治的154例疑似乙肝患者为研究对象,均行CLIA法、ELISA法检测乙肝血清标志物[乙型肝炎表面抗原(HBsAg)、乙型肝炎表面抗体(HBsAb)、乙型肝炎e抗原(HBeAg)、乙型肝炎e抗体(HBeAb)、乙型肝炎核心抗体(HBcAb)]水平,以荧光定量聚合酶链反应(PCR)法检测结果为金标准,比较CLIA法与ELISA法在乙肝中的诊断效能及对低水平HBsAg的检出率。结果:154例疑似乙肝患者中,荧光定量PCR法诊断阳性92例,阴性62例;HBsAg水平0.06~0.10 U/mL 5例,0.11~0.50 U/mL 5例,0.51~2.50 U/mL 8例,2.51~3.00 U/mL 2例。CLIA法诊断阳性89例,阴性65例;ELISA法诊断阳性78例,阴性76例。CLIA法诊断乙肝的灵敏度、准确度、阴性预测值均高于ELISA法,漏诊率低于ELISA法,差异有统计学意义(P<0.05)。CLIA法对HBsAg水平0.06~0.10 U/mL的检出率高于ELISA法,差异有统计学意义(P<0.05)。结论:CLIA法在乙肝中的诊断效能高于ELISA法。
Objective:To compare efficiencies of chemiluminescence immunoassay(CLIA)and enzyme-linked immunosorbent assay(ELISA)in diagnosis of viral hepatitis type B(hepatitis B).Methods:A total of 154 patients with suspected hepatitis B admitted to the hospital from May 2020 to May 2022 were selected as the research objects.The levels of hepatitis B serum markers[hepatitis B surface antigen(HBsAg),hepatitis B surface antibody(HBsAb),hepatitis B e antigen(HBeAg),hepatitis B e antibody(HBeAb),hepatitis B core antibody(HBcAb)]were detected by CLIA and ELISA.Using the results of fluorescence quantitative polymerase chain reaction(PCR)as the gold standard,the diagnostic efficiencies of CLIA and ELISA for hepatitis B and the detection rate of low-level HBsAg were compared.Results:Among the 154 suspected hepatitis B patients,92 cases were positive and 62 cases were negative by fluorescence quantitative PCR;the HBsAg levels were 0.06-0.10 U/mL in 5 cases,0.11-0.50 U/mL in 5 cases,0.51-2.50 U/mL in 8 cases,and 2.51-3.00 U/mL in 2 cases.There were 89 positive cases and 65 negative cases diagnosed by CLIA.There were 78 cases were positive and 76 cases were negative by ELISA.The sensitivity,the accuracy and the negative predictive value of CLIA in the diagnosis of hepatitis B were higher than those of ELISA,the missed diagnosis rate was lower than that of ELISA,and the differences were statistically significant(P<0.05).The detection rate of HBsAg level of 0.06-0.10 U/mL by CLIA method was higher than that by ELISA method,and the difference was statistically significant(P<0.05).Conclusions:The diagnostic efficiency of CLIA in hepatitis B is higher than that of ELISA.
作者
胡加运
王瑞朋
李晓
HU Jiayun;WANG Ruipeng;LI Xiao(Department of Clinical Laboratory of Jinshui District General Hospital,Zhengzhou 450000 Henan,China)
出处
《中国民康医学》
2024年第3期135-137,共3页
Medical Journal of Chinese People’s Health
关键词
化学发光免疫分析法
酶联免疫吸附法
乙型病毒性肝炎
血清学标志物
效能
Chemiluminescence immunoassay
Enzyme-linked immunosorbent assay
Viral hepatitis type B
Serological marker
Efficiency
