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| 日立7100生化分析仪BUN、CK指标的性能验证 |
| Performance Verification of BUN、CK of Hitachi 7100 Biochemical Analyzer Detection System |
| 投稿时间：2018-04-17 |
| DOI： |
| 中文关键词:7100全自动生化分析仪 精密度 正确度 |
| 英文关键词:7100 automatic biochemical analyzer precision accuracy |
| 基金项目:上海市体育科技重点备战计划项目（15J001） |
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| 中文摘要: |
| 目的：对日立7100全自动生化分析仪的血尿素氮（BUN）、肌酸激酶（CK）项目从精密度、正确度、参考区间进行性能验证，保证其检测结果的可信度。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进行性能验证。结果：7100全自动生化分析仪的BUN、CK项目批内精密度均小于1/4TEa（实验室允许总误差）、批间精密度均小于1/3TEa；正确度均小于1/2TEa；参考区间验证通过，本实验室可以直接使用厂商提供的参考区间。结论:日立7100全自动生化分析仪及配套试剂系统，其分析性能符合质量目标要求。 |
| 英文摘要: |
| Objective: To verify the analytical performance of the precision, accuracy, reference range linearity of Hitachi 7100 biochemical analyzer so as to ensure the credibility of test results. Method: According to the documents (EP5-A and EP6-A) of the Clinical and Laboratory Standards Institute(CLSI) to verify the analytical performance. Result: The within-run precision of BUN and CK was less than 1 /4TEa (Laboratory permissible total error). The between-run precision was less than 1/3TEa. The accuracy was not more than 1/2 TEa and the linearity range was within the manufacturer's standards．The laboratory may directly use the reference range provided by the manufacturer. Conclusion: The analytical performance of Hitachi 7100 automatic biochemical analyzer and the supporting reagent system meet the quality standards. |
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