| 胡泽斌,李博,曲守方,黄杰.流式细胞术检测试剂质量控制要点分析[J].中国药事,2021,35(10):1142-1148 |
| 流式细胞术检测试剂质量控制要点分析 |
| Analysis to the Key Points of Quality Control for Flow Cytometry Detection Reagents |
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| DOI：10.16153/j.1002-7777.2021.10.009 |
| 中文关键词: 流式试剂 行业标准 专家共识 医疗器械监督管理条例 质量评价 |
| 英文关键词: flow cytometry reagents industry standards expert consensus regulations on the supervision and administration of medical devices quality evaluation |
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| 中文摘要: |
| 目的：对流式细胞术检测试剂的性能指标和实验方法的质量控制要点进行分析梳理，旨在促进该类试剂质量评价标准的提高，规范实验操作。方法：对流式细胞仪用单克隆抗体试剂检测中关键性能指标的质量控制要点进行剖析，并结合流式细胞术检测外周血淋巴细胞亚群操作要点进行探讨，提出相关建议。结果与结论：准确度、稀释线性、精密度、染色稳定性和试剂稳定性是流式细胞仪用单克隆抗体试剂检测的关键性能指标，对于试剂的质量至关重要；应设立科学有效的产品性能指标、选择合理的实验方法来确保或提高流式试剂的质量标准，从而满足临床和监管的需要。 |
| 英文摘要: |
| Objective: To sort out and analyze the performance indexes of flow cytometry detection reagents and the quality control points of experimental methods in order to promote the quality evaluation standards of such reagents and standardize experimental operations. Methods: The quality control points of key performance indexes in detecting the monoclonal antibody reagents by flow cytometry were analyzed, the key operation points in the detection of peripheral blood lymphocyte subsets by flow cytometry were discussed, and relevant suggestions were put forward as well. Results and Conclusion: Accuracy, dilution linearity, precision, staining stability and reagent stability are the key performance indexes in detecting monoclonal antibody reagents by flow cytometry, which are critical important to the quality of reagents. Scientific and effective product performance indicators should be established and reasonable experimental methods should be chosen to ensure or improve the quality standards of flow reagents so as to meet the needs of clinical examination and supervision. |
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