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

doi:10.3969/j.issn.1673-8640.2015.12.003

摘要/Abstract

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。

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

Abstract:

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 ide.pngied. 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 inter-analysis 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 2 ELISA 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 ratio of positive predictive value≥95% are helpful for improving the results' reliability and reducing the sample numbers of confirmation assay.

Key words: Anti-hepatitis C virus antibody, Enzyme-linked immunosorbent assay, Repeatability, Diagnostic threshold value

中图分类号:

R446.61

孟存仁, 唐婧, 张朝霞. 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[J]. 检验医学, 2015, 30(12): 1175-1180.

MENG Cunren, TANG Jing, ZHANG Zhaoxia.. Analysis on repeatability and diagnostic threshold value of 2 ELISA systems for anti-HCV antibody determination[J]. Laboratory Medicine, 2015, 30(12): 1175-1180.

图/表 8

参考文献 17

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Addcare系统 (S/CO比值=1)	TECAN+FAME组合系统 (S/CO比值=1)		合计
Addcare系统 (S/CO比值=1)	+		-
+	160	2	162
-	3	37	40
合计	163	39	202

Addcare系统 (S/CO比值=1)	TECAN+FAME组合系统 (S/CO比值=1)		合计
Addcare系统 (S/CO比值=1)	+		-
+	160	2	162
-	3	37	40
合计	163	39	202

抗原强度	Core	NS3	NS4-1	NS4-2	NS5
空白	0	0	59	125	72
+/-	0	1	3	1	2
1+	17	20	19	7	12
2+	125	121	61	9	56

抗原强度	Core	NS3	NS4-1	NS4-2	NS5
空白	0	0	59	125	72
+/-	0	1	3	1	2
1+	17	20	19	7	12
2+	125	121	61	9	56

RIBA	例数	Addcare系统(S/CO比值=1)		TECAN+FAME组合系统(S/CO比值=1)
RIBA	例数	+	-	+	-
+	142	142	0	142	0
-	60	20	40	21	39
合计	202	162	40	163	39