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| 胶体金免疫层析定性检测试剂的质量控制与评价 |
| Quality Control and Evaluation of Colloidal Gold Immunochromatography Qualitative Detection Reagents |
| 投稿时间：2023-02-27 修订日期：2023-12-15 |
| DOI： |
| 中文关键词: 胶体金免疫层析 质量控制 体外诊断试剂 |
| 英文关键词: Colloidal gold immunochromatography Quality Control In vitro diagnostic reagents |
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| 摘要点击次数: 258 |
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| 中文摘要: |
| 目的： 探讨胶体金免疫层析定性检测试剂质量控制技术关键要求，旨在为生产企业、检验机构质量控制及评价提供参考，有效地促进该类体外诊断试剂质量水平的提高。方法：通过对胶体金免疫层析定性检测试剂质量的关键性能要素进行剖析，提出相应建议，提高试剂质量。结果与结论：膜条宽度、液体移行速度、阴性符合率、阳性符合率、检出限、重复性是胶体金免疫层析定性检测试剂质量控制及评价的关键性能指标，对于试剂的质量至关重要。在生产及检验环节对这些关键性能指标进行控制，提高试剂的质量标准，从而满足临床和监管的需求。 |
| 英文摘要: |
| Abstract Objective: To discuss the key requirements of quality control technology for colloidal gold immunochromatography qualitative detection reagents, aims to provide reference for quality control and evaluation of production enterprises and inspection institutions, effectively promoted the quality level of such in vitro diagnostic reagents. Method: Analyze the key performance factors of colloidal gold immunochromatography qualitative detection reagent quality, put forward corresponding suggestions, improve reagent quality. Results and Conclusion: Membrane width, liquid migration speed, negative compliance rate, positive compliance rate, detection limit and repeatability are the key performance indicators for quality control and evaluation of colloidal gold immunochromatography qualitative detection reagents, which are crucial to the quality of reagents. These key performance indicators are controlled in the production and inspection links to improve the quality standards of reagents, so as to meet the clinical and regulatory needs. |
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