CC反应蛋白荧光免疫层析定量检测试剂的研制及性能评价

目的旨在建立一种人CRP荧光免疫层析快速定量检测试剂。方法采用双抗体夹心法,以羧基荧光微球标记的抗人CRP单克隆抗体及羊抗兔IgG为标记抗体,另外一株抗人CRP单克隆抗体作为检测线,制备荧光免疫层析试纸条。结果研制的检测试剂盒检测限为0.12 mg/L,CV≤15%,线性范围(0.5~200)mg/L;对223份临床样本进行测试,经配对t检验分析,t=-0.155,P=0.877,与对照试剂性能无显著性差异。结论本研究研制出了一种操作简便、快速的CRP POCT定量检测试剂。

Development and performance evaluation of a quantitative detection method for CRP based on fluorescence immunochromatography

Objective This work aims to develop a rapid quantitative detecting method of fluorescence immunochromatographic assay for human CRP.Methods The kit was prepared with double antibody sandwich technology.The fluorescence immunochromatographic strips were successfully prepared with anti-human CRP monoclonal antibody and goat anti-rabbit IgG marked by carboxyl fluorescent microspheres as the detection antibody,anti-human CRP monoclonal antibody as the test line,and the rabbit IgG as the control line.Results The kit was developed with detection limit of 0.12 mg/L,linear range(0.5~200)mg/L,CV≤15%and with stability of 24 months.223 clinical samples were tested and analyzed by paired t test,t=-0.155,P=0.877,which showed no signifificant difference in performance compare.Conclusion A quantitative CRP test kit was developed with easy to operating and rapid,which can be used for point of care testing testing.