2个酶免疫分析系统检测抗HCV抗体的重复性和诊断阈值分析  

Analysis on repeatability and diagnostic threshold value of 2 ELISA systems for anti-HCV antibody determination

作　　者：孟存仁[1] 唐婧[1] 张朝霞[1] 

机构地区：[1]新疆医科大学第一附属医院医学检验中心,新疆乌鲁木齐830054

出　　处：《检验医学》2015年第12期1175-1180,共6页Laboratory Medicine

基　　金：卫生部医药卫生科技发展研究中心专项课题(28-1-13)

摘　　要：目的分析2个酶免疫分析系统检测抗丙型肝炎病毒(HCV)抗体的重复性和阳性预测值≥95%时的信号/临界值(S/CO)比值。方法分别用Addcare ELISA 1100全自动酶免疫分析系统(简称Addcare系统)和TECAN+FAME组合系统,以间接酶联免疫吸附试验(ELISA)检测抗HCV抗体,重组免疫印迹分析(RIBA)确认抗HCV抗体。收集高、中、低3个水平的样本,在一批检测内重复检测20次(孔),计算分析内精密度;在10 d以上时间内单次(孔或管)重复进行20批检测,计算分析间精密度。收集202份血清,以RIBA确证试验结果为金标准,用受试者工作特征(ROC)曲线分别确定2个检测系统检测抗HCV抗体的最佳诊断阈值(S/CO比值),并分别确定2个检测系统检测抗HCV抗体的阳性预测值≥95%时的S/CO比值的范围。结果 Addcare系统和TECAN+FAME组合系统检测抗HCV抗体的分析内变异系数(CV)分别为5%、8%、10%和3%、7%、8%,分析间CV分别为8%、12%、15%和6%、10%、13%。2个酶免疫分析系统检测抗HCV抗体的最佳诊断阈值(S/CO比值)分别为3.20和2.90。2个酶免疫分析系统检测抗HCV抗体的阳性预测值≥95%时的S/CO比值范围分别为≥2.41和≥2.57。结论国产Addcare系统和进口TECAN+FAME组合系统检测的结果重复性好,符合率高。酶免疫分析系统ELISA检测抗HCV抗体具有各自最佳的S/CO比值,且S/CO比值与确证试验阳性有一定的相关性,可用S/CO比值预测抗HCV抗体阳性。研究确定酶免疫分析系统检测抗HCV抗体最佳诊断阈值和阳性预测值≥95%时的S/CO比值有助于提高检测结果的可靠性,减少须进行确证试验的样本数。Objective To analyze the repeatability and signal-to-cut off（ S / CO） ratio of positive predictive value≥95% in the determination of anti-hepatitis C virus（ HCV） antibody by 2 enzyme-linked immunosorbent assay（ ELISA） systems. Methods Recombinant immunoblot analysis（ RIBA） was used to confirm anti-HCV antibody.Using Addcare ELISA 1100 automatic system（ Addcare system） and TECAN ＋ FAME combined system,by indirect ELISA,anti-HCV antibody was determined. High,medium and low concentrations of samples were collected. In 1 run of determination,the determination was repeated for 20 times（ holes）,and the precision of intra-analysis was calculated.For more than 10 d in a single（ hole or pipe）,20 runs of determinations were performed,and inter-analysis precision was calculated. A total of 202 serum samples were collected,and receiver operating characteristic（ ROC） curve was used to determine the optimal diagnostic threshold value[signal-to-cut off（ S / CO） ratio]of 2 ELISA systems for the determination of anti-HCV antibody. The S / CO ratio scope of positive predictive value ≥95% of anti-HCV antibody determination of 2 ELISA systems was identified. Results The intra-analysis coefficients of variation（ CV） were 5%,8% and 10% for Addcare system and 3%,7% and 8% for TECAN ＋ FAME combined system,while the interanalysis CV were 8%,12%,15% and 6%,10%,13%,respectively. The optimal diagnostic threshold values（ S / CO ratios） of 2 ELISA systems were 3. 20 and 2. 90. The S / CO ratio scopes of positive predictive value ≥95% of anti-HCV antibody determination of 2 ELISA systems were≥2. 41 and≥2. 57. Conclusions The Addcare system and TECAN ＋FAME combined system have excellent repeatability and coincidence rate. The anti-HCV antibody determined by 2ELISA systems has optimal S / CO ratio,and the S / CO ratio is correlated with confirmation assay positivity,so S / CO ratio can be used to predict anti-HCV antibody positivity. The optimal diagnostic threshold value and the S / CO

关 键 词：抗丙型肝炎病毒抗体 酶联免疫吸附试验 重复性 诊断阈值 

分 类 号：H446.61[语言文字]