血吸虫病时间分辨免疫荧光检测试剂盒的研制和效能评价

发布时间：2018-01-11 17:28

  本文关键词：血吸虫病时间分辨免疫荧光检测试剂盒的研制和效能评价　出处：《中国血吸虫病防治杂志》2017年01期 　论文类型：期刊论文

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【摘要】：目的研制日本血吸虫SjP38的时间分辨免疫荧光分析(Time-resolved fluoroimmunoassay,TRFIA)试剂盒,并评价其效能。方法将抗SjP38的9G7单克隆抗体作为捕获抗体包被96孔板,Eu~(3+)标记1A6单克隆抗体作为检测抗体,研制SjP38 TRFIA试剂盒,并评价试剂盒的准确度、灵敏度、精密度、稳定性以及与病原学检测方法的符合率等指标。结果自制试剂盒准确度好,线性范围为2~1 250 ng/ml,最低检出浓度为0.14 ng/ml;精密度良好,分析内精密度为3.6%~4.6%,分析间精密度为5.1%~6.7%。定性试验表明该试剂盒可在4℃稳定半年,37℃稳定7 d。自制试剂盒与病原学检测方法的阳性符合率为95%,阴性符合率为100%。结论所研制试剂盒的各项性能及检测指标均达到临床检验的要求,但临床推广使用还有待进一步的验证。
[Abstract]:Objective to develop a time-resolved fluoroimmunofluorescence assay (TRFIA) kit for SjP38 of Schistosoma japonicum. Methods 1A6 monoclonal antibody was labeled with 9G7 monoclonal antibody (McAb) of SjP38 as a capture antibody coated with a 96-well plate (Eufon 3) as the detection antibody. SjP38 TRFIA kit was developed, and its accuracy, sensitivity, precision, stability and coincidence rate with etiological detection method were evaluated. The linear range is 1 250 ng / ml and the lowest detectable concentration is 0. 14 ng / ml; The precision was good, the analytical precision was 3.6 and 4.6, and the precision was 5.1 and 6.7.The qualitative test showed that the kit could be stabilized at 4 鈩，

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