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流式细胞术产品质量标准的建立及应用

Establishment and Application of Quality Standards for Flow Cytometry Product
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摘要 流式细胞术(Flow cytometry,FCM)是一种对液流中排成单列的细胞或其他生物微粒逐个进行快速定量分析及分选的技术,为人类疾病的检测提供了快速有效的手段。目前已有很多商品化的FCM试剂盒面世,应用于免疫缺陷症、遗传病、细胞周期分析及肿瘤诊断、分型、愈后监测等领域。本文依据标记免疫类产品常规分析方法及产品说明书提供的评价方法,从FCM试剂的外观、准确性、稀释线性、精密性和染色稳定性等要点出发,对FCM产品质量标准的建立及应用作一综述。 Flow cytometry(FCM)is a technique for rapid quantitative analysis and separation of the cells or other biological microparticles in the flow one by one, which provides a rapid and effective method for the diagnosis of human diseases. At present, many commercial kits are available for FCM applied to immune deficiency, genetic disease, cell cycle analysis as well as diagnosis, classification and monitoring the prognosis of tumors, and so on. Based on the conventional immune marker analysis and the method for evaluation provided in the directions, the key points of product quality control and quality standards of FCM kits were summarized, including the appearance, accuracy, dilution linearity, precision and stability of staining.
出处 《中国生物制品学杂志》 CAS CSCD 2010年第10期1144-1146,共3页 Chinese Journal of Biologicals
关键词 流式细胞术 淋巴细胞亚群 质量标准 Flow cytometry(FCM) Lymphocyte subset Quality standard
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