Flow cytometry assay modifications: Recommendations for method validation based on CLSI H62 guidelines.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS
Sara A Monaghan, Steven Eck, Silvia Bunting, Xiangyang X Dong, Robert J Durso, Christele Gonneau, Amanda Hays, Andrea Illingworth, Stacy C League, Eleni Linskens, Megan McCausland, Thomas W McCloskey, Nina Rolf, Min Shi, Paul K Wallace, Virginia Litwin, Wolfgang Kern, George Deeb, Veronica Nash, Horatiu Olteanu
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引用次数: 0

Abstract

The Clinical and Laboratory Standards Institute (CLSI) H62-Validation of Assays Performed by Flow Cytometry guideline, released in 2021, provides recommendations for platform workflow and quality system essentials, instrument setup and standardization, assay development and optimization and fit-for-purpose analytical method validation. In addition, CLSI H62 includes some recommendations for the validation strategies after a validated flow cytometric method has been modified. This manuscript builds on those recommendations and discusses the impact of different types of assay modifications on assay performance. Recommendations regarding which validation parameters to evaluate depending on the type of modification are provided. The impact of assay modification on the assay's intended use is discussed. When recommending minor deviations from the CLSI H62 process for a laboratory-initiated assay revision (e.g., specimen numbers for sensitivity, specificity, or precision studies), a rationale based on expert opinion is provided with the understanding that not every laboratory, assay type, and circumstance can be comprehensively addressed in this paper. These recommendations are meant as a practical recommendation and are not intended to be restrictive, prescriptive, or understood as necessarily sufficient to meet every specific requirement from regulatory bodies (e.g., FDA or New York State Department of Health).

流式细胞仪检测修改:基于 CLSI H62 指南的方法验证建议。
临床与实验室标准协会(CLSI)于 2021 年发布的《H62--流式细胞术检测的验证》指南为平台工作流程和质量体系要点、仪器设置和标准化、检测开发和优化以及适合目的的分析方法验证提供了建议。此外,CLSI H62 还对已验证的流式细胞分析方法修改后的验证策略提出了一些建议。本手稿以这些建议为基础,讨论了不同类型的检测方法修改对检测性能的影响。文中还提供了根据修改类型评估哪些验证参数的建议。还讨论了化验修改对化验预期用途的影响。在建议对实验室发起的检测方法修订(如灵敏度、特异性或精密度研究的标本数量)略微偏离 CLSI H62 流程时,我们会提供基于专家意见的理由,但我们也明白,本文并不能全面涵盖所有实验室、检测方法类型和情况。这些建议只是一种实用性建议,并不具有限制性、规范性,也不能理解为一定能满足监管机构(如美国食品及药物管理局或纽约州卫生局)的所有具体要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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