| 日立7600全自动生化分析仪检测系统性能验证 |
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| 引用本文： | 李婷婷,宁芬,陆雅春.日立7600全自动生化分析仪检测系统性能验证[J].安徽医学,2013,34(11):1679-1682. |
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| 作者姓名： | 李婷婷 宁芬 陆雅春 |
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| 作者单位： | 安徽中医药大学第一附属医院检验中心,合肥,230031;安徽中医药大学第一附属医院检验中心,合肥,230031;安徽中医药大学第一附属医院检验中心,合肥,230031 |
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| 摘 要： | 目的对日立7600全自动生化分析仪的检测系统进行性能验证。方法参照美国临床实验室标准化协会（CLSI）的指南文件EP5-A、EP6-A，对日立7600全自动生化分析仪的精密度、正确度、线性范围、临床可报告范围进行性能评价。结果批内精密度小于1／4TEa（实验室允许总误差）、日间精密度小于1／3TEa；正确度不超过1／2TEa；线性范围、临床可报告范围与厂家说明书提供的性能指标相符。结论日立7600全自动生化分析仪的分析性能符合质量目标要求。
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| 关 键 词： | 全自动生化分析仪 性能验证 精密度 正确度 线性范围 临床可报告范围 |
Performance verification of Hitachi 7600 automatic biochemical analyzer detection system |
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| Li Tingting.Performance verification of Hitachi 7600 automatic biochemical analyzer detection system[J].Anhui Medical Journal,2013,34(11):1679-1682. |
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| Authors: | Li Tingting |
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| Institution: | Li Tingting, Ning Fen, Lu Yachun Clinical Laboratory Center, the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China |
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| Abstract: | Objective To verify the analytical performance of Hitachi 7600 automatic biochemical analyzer. Methods The preci- sion, accuracy, linearity and clinical reportable range were validated according to Clinical and Laboratory Standards Institute （CLSI） docu-ments（ EP5 - A and EP6 - A）. Results The within precision was less than 1/4TEa（ Laboratory permissible total error）, the day precision was less than 1/3TEa, the accuracy was not more than 1/2 TEa, the linearity and clinical reportable range was within the manufacturer＇s standards. Conclusion The analytical performance of Hitachi 7600 automatic biochemical analyzer is consistent with acceptable quality standards. |
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| Keywords: | Automatic biochemical analyzer Performance verification Precision Accuracy Linear range Clinical reportable range |
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