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
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.
Clin Biochem. 2015 Jun;48(9):603-8. doi: 10.1016/j.clinbiochem.2015.01.009. Epub 2015 Jan 26.
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.
Lanthanum elements labeled antibody and streptavidin-biotin system were used in the "capture sandwich" format simultaneously.
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.
The novel dual-TRFIA for RV IgM and CMV IgM detection might have valuable clinical application, with satisfactory sensitivity, specificity and accuracy.
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。
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。
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。
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。
