摘要
目的 T、B淋巴细胞亚类的方法学建立及性能评价。方法 通过查阅文献确立T、B淋巴细胞亚类的抗体组合，沿用溶血洗涤的标本处理方法。基于中华人民共和国卫生部《流式细胞术检测外周血淋巴细胞亚群指南》推荐的方法，建立适用于流式细胞仪性能评价的测试方案，包括精密度、试剂稳定性、抗体量对结果的影响等。结果 T、B淋巴细胞亚类的方法学初步建立，性能评价初步确立。结论 上述性能指标测试方法可靠，能够对T、B淋巴细胞亚类检测性能进行全面评价。该方法对于T、B淋巴细胞亚类检测性能验证有一定的指导意义。
关键词： 流式细胞仪；方法学建立；性能评价
Abstract
Objective To establish the methodology and evaluate the performance of T and B lymphocyte subsets. Methods: the antibody combination of T and B lymphocyte subclasses was established by consulting literature, and the method of hemolytic washing was used. Based on the method recommended by the State Food and drug administration, a test scheme suitable for the performance evaluation of FCM was established, including the precision, the stability of reagents ,the influence about the amount of antibody. Results: the methods of T and B lymphocyte subsets were established preliminarily, and the performance evaluation met the requirements. Conclusion : the above methods are reliable and can be used to evaluate the detection performance of T and B lymphocyte subsets. This method has certain guiding significance for the verification of the detection performance of T and B lymphocyte subsets.
Key words： Flow Cytometry; Methodology Establishment; Performance Evaluation
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