化学发光免疫分析法检测抗TP抗体S/CO比值与确证试验阳性的相关性研究

doi:10.3969/j.issn.1673-8640.2015.12.005

检验医学 ›› 2015, Vol. 30 ›› Issue (12): 1185-1189.DOI: 10.3969/j.issn.1673-8640.2015.12.005

• 正视抗丙型肝炎病毒抗体和抗梅毒螺旋体抗体筛查试验的假阳性问题专题 • 上一篇下一篇

化学发光免疫分析法检测抗TP抗体S/CO比值与确证试验阳性的相关性研究

许晓峰¹, 江铭磊², 卢仁泉², 邹淳缘², 龚志赟², 沈利¹, 郭林²

1.同济大学医学院病原生物学教研室,上海200092
2.复旦大学附属肿瘤医院检验科复旦大学上海医学院肿瘤学系,上海 200032

收稿日期:2015-02-17 出版日期:2015-12-20 发布日期:2016-01-04
作者简介:null
作者简介:许晓峰,男,1976年生,学士,主管技师,主要从事病原体免疫学研究。

通讯作者:沈利,联系电话:021-65985615。

Study on the correlation between anti-TP antibody S/CO ratio by chemiluminescence immunoassay and positive results by confirmation assay

XU Xiaofeng¹, JIANG Minglei², LU Renquan³, ZOU Chunyuan², GONG Zhiyun², SHEN Li¹, GUO Lin²

1.Institute for Infectious Diseases and Vaccine Development, Tongji University School of Medicine, Shanghai 200092, China
2. Department of Clinical Laboratory, Shanghai Cancer Center, Fudan University/Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China

Received:2015-02-17 Online:2015-12-20 Published:2016-01-04

摘要/Abstract

摘要：

目的探讨化学发光免疫分析法(CLIA)检测抗梅毒螺旋体(TP)抗体筛查试验信号/临界值(S/CO)比值与确证试验阳性的相关性。方法经Abbott i2000 CLIA系统(简称Abbott i2000)或科美东雅Chemclin 600 CLIA系统(简称Chemclin 600)检测抗TP抗体S/CO比值≥1.0的血清样本208份,用免疫印迹法(WB)对抗TP抗体筛查试验结果进行确认评价。采用SPSS 19.0软件绘制抗TP抗体S/CO比值受试者工作特性(ROC)曲线,得到敏感性和特异性最佳时的S/CO比值;计算各个S/CO比值区间的阳性预测值,得到阳性预测值≥95%的S/CO比值。结果 Abbott i2000或Chemclin 600检测抗TP抗体S/CO比值≥1.0的血清样本208份,WB检测阳性128份,阴性35份,不确定45份,2个CLIA系统与WB的符合率分别为82.2%和82.8%。当Abbott i2000和Chemclin 600抗TP抗体筛查的S/CO比值分别为≥3.0和≥4.0时,阳性预测值≥95%。结论 Abbott i2000和Chemclin 600检测抗TP抗体的S/CO比值分别为1.0~3.0和1.0~4.0的样本应进行WB确证试验,S/CO比值大于上述上限的样本可直接报告抗TP抗体阳性,这样既能减少确证试验的样本数,又可提高检测报告的可靠性。

关键词: 抗梅毒螺旋体抗体, 化学发光免疫分析法, 免疫印迹法

Abstract:

Objective To investigate the correlation between anti-treponema pallidum(TP)antibody signal-to-cut off(S/CO)ratio by chemiluminescence immunoassay (CLIA) and positive results by confirmation assay.Methods A total of 208 anti-TP antibody positive samples (S/CO ratio≥1.0) were screened out by 2 CLIA systems, Abbott i2000 CLIA system (Abbott i2000)and Kemei Dongya Chemclin 600 CLIA system (Chemclin 600). The results were confirmed by western blotting (WB). Receiver operating characteristic(ROC)curve at optimal sensitivity and specificity was analyzed, and optimal S/CO threshold value was obtained by SPSS 19.0 software. The positive predictive value was calculated with every S/CO ratio interval, and the S/CO ratio of positive predictive value≥95%was obtained. Results By Abbott i2000 or Chemclin 600, 208 samples' S/CO ratio was determined.By WB, 35 cases of them were confirmed as negative, 128 cases were confirmed as positive, and 45 cases were indeterminate.The coincidence rates of WB compared with the 2 CLIA systems were 82.2% and 82.8%, respectively.When anti-TP antibody S/CO ratio of Abbott i2000 was ≥3.0, and anti-TP antibody S/CO ratio of Chemclin 600 was ≥4.0, the positive predictive value was ≥95%. Conclusions It is proposed that WB should be used if the S/CO ratio ranges are 1.0-3.0 determined by Abbott i2000 and 1.0-4.0 determined by Chemclin 600. If the S/CO ratio is above the upper limit, the samples can be reported as positive directly. It can not only reduce the confirmation assay sample number but also improve the reliability of determination report.

Key words: Anti-treponema pallidum antibody, Chemiluminescence immunoassay, Western blotting

中图分类号:

R446.61

许晓峰, 江铭磊, 卢仁泉, 邹淳缘, 龚志赟, 沈利, 郭林. 化学发光免疫分析法检测抗TP抗体S/CO比值与确证试验阳性的相关性研究[J]. 检验医学, 2015, 30(12): 1185-1189.

XU Xiaofeng, JIANG Minglei, LU Renquan, ZOU Chunyuan, GONG Zhiyun, SHEN Li, GUO Lin. Study on the correlation between anti-TP antibody S/CO ratio by chemiluminescence immunoassay and positive results by confirmation assay[J]. Laboratory Medicine, 2015, 30(12): 1185-1189.

图/表 6

参考文献 13

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抗TP抗体的 S/CO比值	Chemclin 600				Abbott i2000
	WB			阳性预测值(%)	WB			阳性预测值(%)
	-			+	不确定	-	+	不确定
0~0.99	8	1	3	11.1	9	3	3	25.0
1~1.99	17	6	26	26.1	22	9	31	29.0
2~2.99	4	6	7	60.0	3	25	7	89.3
3~3.99	5	12	0	70.6	1	24	2	96.0
4~4.99	1	20	4	95.2	0	15	1	100.0
5~5.99	0	12	2	100.0	0	12	0	100.0
6~9.99	0	6	2	100.0	0	15	1	100.0
10~19.99	0	6	0	100.0	0	7	0	100.0
20~29.99	0	24	0	100.0	0	18	0	100.0
30~39.99	0	24	1	100.0	0	0	0	-
≥40	0	11	0	100.0	0	0	0	-

抗TP抗体的 S/CO比值	Chemclin 600				Abbott i2000
	WB			阳性预测值(%)	WB			阳性预测值(%)
	-			+	不确定	-	+	不确定
0~0.99	8	1	3	11.1	9	3	3	25.0
1~1.99	17	6	26	26.1	22	9	31	29.0
2~2.99	4	6	7	60.0	3	25	7	89.3
3~3.99	5	12	0	70.6	1	24	2	96.0
4~4.99	1	20	4	95.2	0	15	1	100.0
5~5.99	0	12	2	100.0	0	12	0	100.0
6~9.99	0	6	2	100.0	0	15	1	100.0
10~19.99	0	6	0	100.0	0	7	0	100.0
20~29.99	0	24	0	100.0	0	18	0	100.0
30~39.99	0	24	1	100.0	0	0	0	-
≥40	0	11	0	100.0	0	0	0	-

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化学发光免疫分析法检测抗TP抗体S/CO比值与确证试验阳性的相关性研究

Study on the correlation between anti-TP antibody S/CO ratio by chemiluminescence immunoassay and positive results by confirmation assay

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Metrics

Abbott i2000	Chemclin 600		合计
Abbott i2000	S/CO比值≥1.0		S/CO比值<1.0
S/CO比值≥1.0	181	12	193
S/CO比值<1.0	15	0	15
合计	196	12	208

CLIA系统	例数	WB
CLIA系统	例数	+	-	不确定
Abbott i2000
+	193	125	26	42
-	15	3	9	3
合计	208	128	35	45
Chemclin 600
+	196	127	27	42
-	12	1	8	3
合计	208	128	35	45