均相酶免疫法与胶乳增强免疫比浊法检测甘胆酸的方法学比较

doi:10.3969/j.issn.1673-8640.2017.08.013

检验医学 ›› 2017, Vol. 32 ›› Issue (8): 718-721.DOI: 10.3969/j.issn.1673-8640.2017.08.013

• 技术研究与评价·论著 • 上一篇下一篇

均相酶免疫法与胶乳增强免疫比浊法检测甘胆酸的方法学比较

梁运来, 廖经忠, 王堃, 谢旭琳, 易斌

中南大学湘雅医院,湖南长沙 410008

收稿日期:2017-01-03 出版日期:2017-08-30 发布日期:2017-09-01
作者简介:null
作者简介：梁运来,男,1991年生,硕士,主要从事肿瘤临床生化实验诊断研究。

通信作者：廖经忠,联系电话：0731-84327431。

Comparison of homogeneous enzyme immunoassay and latex-enhanced immunoturbidimetric assay for the determination of cholyglycine

LIANG Yunlai, LIAO Jingzhong, WANG Kun, XIE Xulin, YI Bin

Xiangya Hospital of Central South University,Changsha 410008,Hunan,China

Received:2017-01-03 Online:2017-08-30 Published:2017-09-01

摘要/Abstract

摘要：

目的对均相酶免疫法和胶乳增强免疫比浊法检测甘胆酸（CG）进行方法学比对,为临床实验室选择合适的检测方法提供参考。方法对2种方法的阳性率、试剂盒批内精密度、线性范围分别进行比较,再分别用2种方法检测248例临床标本,对结果进行统计分析。结果均相酶免疫法和胶乳增强免疫比浊法检测CG的阳性率分别为53.23%和51.21%,阳性符合率为97.58%;批内精密度实验中高值血清变异系数（CV）分别为1.13%和2.65%,低值血清CV分别为3.52%和7.51%;线性评价试验中,均相酶免疫法线性回归方程为Y=1.068 2X+0.421 6,相关系数（r） =0.995 7;胶乳增强免疫比浊法线性回归方程为Y=1.016 1X+0.875 2,r =0.997 7。2种方法临床标本检测结果回归方程Y=1.156X+0.543,决定系数（R²）=0.98。结论 2种检测方法具有良好的一致性,其测定结果准确、稳定、可靠,能满足临床检测需求;但均相酶免疫法检测稳定性显著优于胶乳增强免疫比浊法。

关键词: 甘胆酸, 均相酶免疫法, 胶乳增强免疫比浊法

Abstract:

Objective To compare homogeneous enzyme immunoassay and latex-enhanced immuno-turbidimetric assay for the determination of cholyglycine（CG）,and to provide a reference for selecting appropriate method. Methods The positive rates,precisions and linear ranges of the 2 methods were compared,and then 248 samples were determined by the 2 methods for statistical analysis. Results The positive rates of homogeneous enzyme immunoassay and latex-enhanced immunoturbidimetric assay were 53.23% and 51.21%,and the positive coincidence rate was 97.58%. The coefficients of variation （CV）of within-run precision for high-value serum were 1.13% and 2.65%,and those for low-value serum were 3.52% and 7.51%,respectively. In linear evaluation,the linear regression equation of homogeneous enzyme immunoassay was Y=1.068 2X+0.421 6（r =0.995 7）,and the linear regression equation of latex-enhanced immunoturbidimetric assay was Y=1.016 1X+0.875 2（r =0.997 7）. The relationship between the 2 methods was Y=1.156X+0.543 [coefficient of determination（R²）=0.98]. Conclusions The results of the 2 methods have high consistency,and they have good accuracy,stability and reliability,which meet clinical determination requirements. However,the stability of homogeneous enzyme immunoassay is better than that of latex-enhanced immunoturbidimetric assay.

Key words: Cholyglycine, Homogeneous enzyme immunoassay, Latex-enhanced immunoturbidimetric assay

中图分类号:

R446.1

梁运来, 廖经忠, 王堃, 谢旭琳, 易斌. 均相酶免疫法与胶乳增强免疫比浊法检测甘胆酸的方法学比较[J]. 检验医学, 2017, 32(8): 718-721.

LIANG Yunlai, LIAO Jingzhong, WANG Kun, XIE Xulin, YI Bin. Comparison of homogeneous enzyme immunoassay and latex-enhanced immunoturbidimetric assay for the determination of cholyglycine[J]. Laboratory Medicine, 2017, 32(8): 718-721.

图/表 2

参考文献 23

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组别	回归方程	r值
正常对照组	Y=0.959X+0.622	0.952
无症状HBV携带组	Y=1.279X+0.328	0.997
非重症肝炎组	Y=1.064X+1.214	0.981
重症肝炎组	Y=0.978X+5.803	0.997
胆道梗阻性疾病组	Y=1.024X+0.313	0.999
肝硬化组	Y=1.096X+2.528	0.991
肝癌组	Y=1.253X+0.373	0.986

组别	回归方程	r值
正常对照组	Y=0.959X+0.622	0.952
无症状HBV携带组	Y=1.279X+0.328	0.997
非重症肝炎组	Y=1.064X+1.214	0.981
重症肝炎组	Y=0.978X+5.803	0.997
胆道梗阻性疾病组	Y=1.024X+0.313	0.999
肝硬化组	Y=1.096X+2.528	0.991
肝癌组	Y=1.253X+0.373	0.986

均相酶免疫法与胶乳增强免疫比浊法检测甘胆酸的方法学比较

Comparison of homogeneous enzyme immunoassay and latex-enhanced immunoturbidimetric assay for the determination of cholyglycine

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