斑点免疫金渗滤法定量测定血清淀粉样蛋白A方法的建立及性能评估

被引：7

作者：

陈长强 ^{[1
]}

杨晶 ^{[2
]}

顾志冬 ^{[1
]}

万颖蕾 ^{[1
]}

毛客自 ^{[1
]}

冯晓静 ^{[1
]}

徐建新 ^{[2
]}

樊绮诗 ^{[1
]}

机构：

[1] 上海交通大学医学院附属瑞金医院检验科

[2] 上海奥普生物医药有限公司研发中心

来源：

检验医学 | 2013年 / 28卷 / 09期

关键词：

斑点免疫金渗滤法; 血清淀粉样蛋白A; 即时检验; 乳胶增强速率散射比浊法;

D O I：

暂无

中图分类号：

R446.61 [免疫学检验方法];

学科分类号：

100208 ;

摘要：

目的建立斑点免疫金渗滤法(DIGFA)定量测定血清淀粉样蛋白A(SAA)并评估其分析性能。方法选用2株商品化抗SAA单克隆抗体,分别结合于硝酸纤维素膜和胶体金,制备免疫金渗滤试剂板条(SAADOT)以定量检测SAA。按照EP文件,评估SAA-DOT的分析性能(检测限、精密度、准确性、线性范围等)。结果SAA-DOT最低检测限为5 mg/L;10和100 mg/L的批内变异系数(CV)分别为9.07%和10.21%,天间CV分别为11.33%和11.53%;线性范围为5～230 mg/L;SAA-DOT的测定结果与商品化乳胶增强速率散射比浊法(LERN)试剂具有良好的相关性(r=0.995,P<0.05)。表观健康者血清SAA浓度中位数为5.7 mg/L,95%可信区间为0～9.6 mg/L。结论基于DIGFA的SAA-DOT简便、快速,能在5 min内完成检测,各项分析性能指标达到国家食品药品监督管理局(SFDA)对体外诊断试剂的要求,可用于临床患者血清标本的检测。

引用

页码：835 / 840

页数：6

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