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用于测定人血清中风疹病毒和巨细胞病毒IgM抗体的双标记时间分辨免疫荧光分析法。

Dual-labeled time-resolved immunofluorometric assay for the determination of IgM antibodies to rubella virus and cytomegalovirus in human serum.

作者信息

Zhou Jian-Wei, Lei La-Mei, Liang Qian-Ni, Liu Tian-Cai, Lin Guan-Feng, Dong Zhi-Ning, Liang Rong-Liang, Chen Zhen-Hua, Wu Ying-Song

机构信息

Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.

Institute of Hydrobiology, Jinan University, Guangzhou 510515, Guangdong, PR China.

出版信息

Clin Biochem. 2015 Jun;48(9):603-8. doi: 10.1016/j.clinbiochem.2015.01.009. Epub 2015 Jan 26.

Abstract

OBJECTIVES

This study established a novel time-resolved fluorescence immunoassay (TRFIA) that allows the simultaneous determination of rubella virus (RV) IgM and cytomegalovirus (CMV) IgM in human serum.

DESIGN AND METHODS

Lanthanum elements labeled antibody and streptavidin-biotin system were used in the "capture sandwich" format simultaneously.

RESULTS

The working range of TRFIA for RV IgM was 2-80 AU/mL and for CMV IgM was 5-400 AU/mL. Intra- and inter-assay coefficient of variation (CV) for RV IgM and CMV IgM were both less than 10% and recoveries were from 90% to 110%. No significant statistical difference in sensitivity or specificity was observed between dual-TRFIA and commercial chemiluminescent immunoassays (CLIA) in serum samples.

CONCLUSION

The novel dual-TRFIA for RV IgM and CMV IgM detection might have valuable clinical application, with satisfactory sensitivity, specificity and accuracy.

摘要

目的

本研究建立了一种新型时间分辨荧光免疫分析法(TRFIA),可同时检测人血清中的风疹病毒(RV)IgM和巨细胞病毒(CMV)IgM。

设计与方法

采用镧元素标记抗体和链霉亲和素-生物素系统,同时采用“捕获夹心”形式。

结果

TRFIA检测RV IgM的工作范围为2-80 AU/mL,检测CMV IgM的工作范围为5-400 AU/mL。RV IgM和CMV IgM的批内和批间变异系数(CV)均小于10%,回收率为90%至110%。在血清样本中,双TRFIA与商业化学发光免疫分析法(CLIA)在敏感性或特异性方面未观察到显著统计学差异。

结论

用于检测RV IgM和CMV IgM的新型双TRFIA可能具有重要的临床应用价值,其敏感性、特异性和准确性令人满意。

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