| 体外诊断技术发展概况及检测实验室质量管理的探讨 |
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| 引用本文： | 李丽莉,李颖,毕玉春,高瑛瑛.体外诊断技术发展概况及检测实验室质量管理的探讨[J].中国药事,2019,33(10):1102-1108. |
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| 作者姓名： | 李丽莉 李颖 毕玉春 高瑛瑛 |
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| 作者单位： | 中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国合格评定国家认可委员会, 北京 100062,中国合格评定国家认可委员会, 北京 100062 |
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| 摘 要： | 目的：探讨体外诊断检测实验室质量控制技术关键要求，有效地促进检验工作质量的改进提高。方法：通过对体外诊断检验技术进行梳理、汇总，从原始记录、试剂耗材、设施环境、仪器设备、废弃物处置及溯源性等方面，剖析实验室质量管理关键要素，提高检验工作质量。结果与结论：实验室应将体外诊断技术特点与质量管理要素紧密结合，制定符合本实验室实际工作情况的规范性文件，对实验室进行精细化管理。
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| 关 键 词： | 体外诊断 检验技术 质量管理 关键要素 |
| 收稿时间： | 2019/6/10 0:00:00 |
On the Development of In Vitro Diagnostic Technology and the Quality Control of Testing Laboratories |
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| Li Lili,Li Ying,Bi Yuchun and Gao Yingying.On the Development of In Vitro Diagnostic Technology and the Quality Control of Testing Laboratories[J].Chinese Pharmaceutical Affairs,2019,33(10):1102-1108. |
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| Authors: | Li Lili Li Ying Bi Yuchun and Gao Yingying |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,China National Accreditation Service for Conformity Assessment, Beijing 100062, China and China National Accreditation Service for Conformity Assessment, Beijing 100062, China |
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| Abstract: | Objective: To explore the key requirements of quality control technology for in vitro diagnostic testing laboratories and effectively improve the quality of testing work.Methods: In vitro diagnostic testing techniques were analyzed and summarized. The key elements of laboratory quality management were analyzed from the following aspects: original records, reagents, facility environment, instruments and equipment, waste disposal and traceability in order to improve the quality of testing work.Results and Conclusion: The characteristics of in vitro diagnostic technology should be closely combined with key elements of quality management in the laboratories. Normative documents that conform to actual working conditions of the laboratories should be developed, and refined management of the laboratories should be carried out. |
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| Keywords: | in vitro diagnosis testing techniques quality control key elements |
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