| 国产他克莫司测定试剂盒分析性能评估 |
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| 引用本文： | 刘振红,冯艳青,吕平,张丽,刘志国,毛远丽.国产他克莫司测定试剂盒分析性能评估[J].中国卫生检验杂志,2011(12). |
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| 作者姓名： | 刘振红 冯艳青 吕平 张丽 刘志国 毛远丽 |
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| 作者单位： | 解放军三○二医院临床输血中心; |
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| 摘 要： | 目的:评价国产他克莫司测定试剂盒(微粒子酶联免疫法检测法,MEIA)的各项分析性能,了解其是否满足临床使用要求。方法:参照他克莫司产品标准,对试剂盒的分析灵敏度、线性、准确性、批内精密度、批间差以及稳定性进行了考察。结果:该试剂盒的分析灵敏度为0.95 ng/ml,线性系数平方为0.999,高、中、低三个质控品的准确性分别为:0.8%,8.1%和9.4%,高、低值质控品批内间差分别为6.1%和12.6%,批间差为1.6%,均符合产品标准的要求,对刚过期产品同时进行以上项目检测,也符合产品标准要求。结论:国产他克莫司测定试剂盒(微粒子酶联免疫法检测法)各项分析性能均符合标准要求,满足临床实验室的使用要求。
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| 关 键 词： | 他克莫司 FK506 血药浓度检测 微粒子酶联免疫检测法 性能评估 |
Performance evaluation of domestic tacrolimus assay kit |
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| LIU Zhen-hong,FENG Yan-qing,LV Ping,ZHANG Li,LIU Zhi-guo,MAO Yuan-li.Performance evaluation of domestic tacrolimus assay kit[J].Chinses Journal of Health Laboratory Technology,2011(12). |
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| Authors: | LIU Zhen-hong FENG Yan-qing LV Ping ZHANG Li LIU Zhi-guo MAO Yuan-li |
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| Affiliation: | LIU Zhen-hong,FENG Yan-qing,LV Ping,ZHANG Li,LIU Zhi-guo,MAO Yuan-li(Clinical Blood Transfusion Center,302 Military Hospital of China,Beijing 100039,China) |
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| Abstract: | Objective:To evaluate the general performance of tacrolimus assay kit(microparticle enzyme-linked immunosorbent assay,MEIA) with systemic analytic experiments to see if they meet clinical requirements.Methods: Refering to tacrolimus product standards,the kit sensitivity,linearity,accuracy,intra-assay precision,precision between different assays and stability were studied.Results: The sensitivity of the kit was 0.95 ng/ml,the linear coefficient(R2) was 0.999,the accuracy of the control materials with high,me... |
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| Keywords: | Tacrolimus FK506 Blood drug concentration detection Microparticle enzyme-linked immunosorbent assay Performance evaluation |
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