Clinical Laboratory Center, The Tumor Hospital Affiliated to Xin Jiang Medical University, Urumqi, China.
J Clin Lab Anal. 2020 Nov;34(11):e23481. doi: 10.1002/jcla.23481. Epub 2020 Aug 15.
The aim of this study is to compare double-antigen sandwich enzyme-linked immunosorbent assay (ELISA) and indirect ELISA in the diagnosis of hepatitis C virus（HCV）infection.
A total of 176 samples from the Tumor Hospital Affiliated to Xin Jiang Medical University were utilized to comparison. All serum samples were tested using double-antigen sandwich ELISA and indirect ELISA. Cohen's kappa statistics were used to assess the agreement between the two assays, and multivariate analysis was used to evaluate risk factors for the discordance between the double-antigen ELISA and indirect ELISA.
The positivities of indirect ELISA (Beijing Wantai), double-antigen sandwich ELISA (Beijing Wantai), and indirect ELISA (Beijing Jinhao) were 74.43%, 68.75%, and 73.30%, respectively. The agreement between the indirect ELISA (Beijing Wantai) and double-antigen sandwich ELISA (Beijing Wantai) was high (κ = 0.829;P < .001), and the agreement between the double-antigen sandwich ELISA (Beijing Wantai) and indirect ELISA (Beijing Jinhao) was high (κ = 0.847;P < .001). Variables associated with discordant results between the double-antigen sandwich and indirect ELISA in multivariate analysis were as follows: female (OR:1.462; P < .05), age (<35 years old; OR:3.667; P < .05), and cancer (suffer from malignant tumor; OR:3.621; P < .05).
In detection of HCV, high agreement was found between the double-antigen sandwich ELISA and indirect ELISA. Female, younger age, and suffer from malignant tumor were significant risk factors for the discordance. Based on double-antigen sandwich ELISA has distinct methodological advantages over indirect ELISA. It is recommended for the diagnosis of HCV infection.
本研究旨在比较双抗原夹心酶联免疫吸附试验（ELISA）和间接 ELISA 在丙型肝炎病毒（HCV）感染诊断中的应用。
采用新疆医科大学附属肿瘤医院 176 例血清标本进行对比。采用双抗原夹心 ELISA 和间接 ELISA 对所有血清样本进行检测。采用 Cohen's kappa 统计分析两种检测方法的一致性，采用多因素分析评估双抗原 ELISA 与间接 ELISA 不一致的影响因素。
间接 ELISA（北京万泰）、双抗原夹心 ELISA（北京万泰）、间接 ELISA（北京金豪）的阳性率分别为 74.43%、68.75%、73.30%。间接 ELISA（北京万泰）与双抗原夹心 ELISA（北京万泰）之间的一致性较高（κ=0.829；P<0.001），双抗原夹心 ELISA（北京万泰）与间接 ELISA（北京金豪）之间的一致性也较高（κ=0.847；P<0.001）。多因素分析显示，双抗原夹心 ELISA 与间接 ELISA 结果不一致的相关变量如下：女性（OR：1.462；P<0.05）、年龄（<35 岁；OR：3.667；P<0.05）、癌症（患有恶性肿瘤；OR：3.621；P<0.05）。
在 HCV 检测中，双抗原夹心 ELISA 与间接 ELISA 具有高度一致性。女性、年龄较小和患有恶性肿瘤是导致两者不一致的显著危险因素。鉴于双抗原夹心 ELISA 具有明显优于间接 ELISA 的方法学优势，建议用于 HCV 感染的诊断。
