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光激化学发光分析法定性检测血清CMV-IgM抗体
引用本文:刘浩1,2,李军普1,崔亚琼1,于洋1,张月香2,李会强1. 光激化学发光分析法定性检测血清CMV-IgM抗体[J]. 天津医科大学学报, 2020, 0(3): 261-265
作者姓名:刘浩1  2  李军普1  崔亚琼1  于洋1  张月香2  李会强1
作者单位:(1.天津医科大学医学检验学院,天津300203;2.天津市中心妇产科医院检验科,天津300100)
摘    要:目的:建立一种基于光激化学发光分析(LiCA)技术定性检测血清CMV-IgM抗体的新方法。方法:利用CMV抗原包被的发光微球,生物素标记的鼠抗人IgM抗体以及链霉亲和素包被的感光微球共同构成完整的分析体系,优化反应缓冲液、抗原抗体工作浓度和待检血清稀释比例,并进行方法学评价和临床结果比对。结果:本方法的批内和批间变异系数为5.3%~6.1%和6.9%~9.8%,均小于10%;ROC曲线分析显示,曲线下面积为0.997,灵敏度为100%,特异度为98.9%;在100例血清样本的检测中,本方法与LIAISON检测结果符合率为95.0%。结论:成功建立了LiCA间接法反应模式定性检测CMV-IgM抗体的方法。该检测方法操作简单、快速、灵敏度高,有潜在的临床应用前景。

关 键 词:CMV-IgM抗体  产前筛查  光激化学发光分析  均相免疫分析  定性分析

Qualitative detecting CMV-IgM in human serum based on a light-initiated chemiluminescent assay
LIU Hao1,' target="_blank" rel="external">2,LI Jun-pu1,CUI Ya-qiong1,YU Yang1,ZHANG Yue-xiang2,LI Hui-qiang1. Qualitative detecting CMV-IgM in human serum based on a light-initiated chemiluminescent assay[J]. Journal of Tianjin Medical University, 2020, 0(3): 261-265
Authors:LIU Hao1,' target="  _blank"   rel="  external"  >2,LI Jun-pu1,CUI Ya-qiong1,YU Yang1,ZHANG Yue-xiang2,LI Hui-qiang1
Affiliation:(1.Department of Clinical Laboratory, School of Medical Laboratory, Tianjin Medical University, Tianjin 300203, China;2. Department of Laboratory Medicine, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China)
Abstract:Objective: To establish a light-initiated chemiluminescent assay (LiCA) for qualitative detection of CMV-IgM antibody in human serum. Methods: The assay was performed by incubating CMV antigen-coated chemibeads, biotinylated mouse anti-human IgM antibody and streptavidin-coated sensibeads. The assay buffer, working concentration of antigen and antibody and dilution ratio of serum were optimized. Furthermore, analytical performance was evaluated and the consistency of the results between LiCA and LIAISON was tested. Results: The intraassay and interassay coefficient of variation were both less than 10%, ranging from 5.3% to 6.1% and 6.9% to 9.8%. ROC curve analysis showed that the area under the curve, sensitivity and specificity were 0.997, 100%, and 98.9%, respectively. The accordance rate was 95.0% between LiCA and LIAISON in the measurement of CMV-IgM antibody in 100 serum samples. Conclusion: Indirect LiCA for qualitative detection of CMV-IgM antibody has been successfully established. The assay is simple, rapid, highly sensitive and has potential clinical prospects.
Keywords:CMV-IgM antibody  prenatal screening  light-initiated chemiluminescent assay  homogeneous immunoassay  qualitative analysis
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