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Flow cytometric method transfer: Recommendations for best practice
Cytometry Part B: Clinical Cytometry ( IF 2.3 ) Pub Date : 2020-11-18 , DOI: 10.1002/cyto.b.21971
Maciej Cabanski 1 , Teri Oldaker 2 , Jennifer J Stewart 3 , Nithianandan Selliah 4 , Steve Eck 5 , Cherie Green 6 , Virginia Litwin 7 , Alessandra Vitaliti 1
Affiliation  

As with many aspects of the validation and monitoring of flow cytometric methods, the method transfer processes and acceptance criteria described for other technologies are not fully applicable. This is due to the complexity of the highly configurable instrumentation, the complexity of cellular measurands, the lack of qualified reference materials for most assays, and limited specimen stability. There are multiple reasons for initiating a method transfer, multiple regulatory settings, and multiple context of use. All of these factors influence the specific requirements for the method transfer. This recommendation paper describes the considerations and best practices for the transfer of flow cytometric methods and provides individual case studies as examples. In addition, the manuscript emphasizes the importance of appropriately conducting a method transfer on data reliability.

中文翻译:

流式细胞仪方法转移:最佳实践建议

与流式细胞仪方法验证和监测的许多方面一样,为其他技术描述的方法转移过程和验收标准并不完全适用。这是由于高度可配置的仪器的复杂性、细胞被测量的复杂性、大多数测定缺乏合格的参考材料以及样本稳定性有限。启动方法转移有多种原因、多种监管设置和多种使用环境。所有这些因素都会影响方法转移的具体要求。本推荐文件描述了流式细胞仪方法转移的注意事项和最佳实践,并提供了个别案例研究作为示例。此外,
更新日期:2021-01-21
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