人血清淀粉样蛋白A荧光免疫层析检测试剂盒的研制

Development of fluorescence immunochromatography assay kit for detection of human serum amyloid A

目的研制一种人血清淀粉样蛋白A(SAA)荧光定量免疫层析检测试剂盒,并对其性能进行初步评价。方法建立了一种基于时间分辨荧光微球的荧光免疫层析检测试剂盒(以下简称自制试剂盒)用于人SAA的定量检测,通过测试空白限、精密度、稳定性、与对比试剂盒的符合率,评价其性能。结果自制试剂盒的空白限为0.49 mg/L,批内变异系数小于15%,在热稳定性测试中表现出较好的稳定性,与西门子人SAA试剂盒具有良好相关性(R^2=0.9605)。结论自制的人SAA荧光定量免疫层析试剂盒可适用于SAA的临床检测。

Objective To develop a fluorescence immunochromatography assay kit for detection of human serum amyloid A(SAA)and to preliminarily evaluate its performance.Methods The fluorescence immunochromatography assay kit based on time-resolved fluorescent microspheres(hereinafter referred to as self-made kit)was established for the quantitative detection of human SAA.Its performance was evaluated by testing limit of blank,precision,stability and coincidence rate with the comparison kit.Results The limit of blank of the self-made kit was 0.49 mg/L,and the coefficient of variation within the batch was less than 15%.It showed good stability in the thermal stability test and had good correlation with the Siemens SAA kit(R 2=0.9605).Conclusion The self-made kit of fluorescence quantitative immunochromatography for human SAA can be used for clinical detection of SAA.