使用定性和半定量流式细胞术分析的真实实例的验证注意事项摘要。

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS
Katherine A. Devitt, Teri Oldaker, Kalpesh Shah, Andrea Illingworth
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引用次数: 1

摘要

在临床实验室中,流式细胞术检测对于向治疗临床医生提供诊断和预后信息至关重要。验证或验证提供了这样的信心,即该测定将产生可靠的结果,可以信赖该结果来做出关键的医疗决策。根据需要,实验室开发测试的验证应包括以下性能规范:准确性(或真实性)、精密度(再现性和可重复性)、检测能力、选择性、参考范围以及样品和试剂的稳定性。我们定义了这些术语,并介绍了几种常见的流式细胞术检测的验证方法,包括白血病/淋巴瘤检测和阵发性夜间血红蛋白尿(PNH)检测的例子。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Summary of validation considerations with real-life examples using both qualitative and semiquantitative flow cytometry assays

In the clinical laboratory, flow cytometry assays are critical to providing diagnostic and prognostic information to the treating clinicians. A validation or verification provides confidence that the assay will yield reliable results that can be trusted to make critical medical decisions. The following performance specifications should be included in a validation for laboratory developed tests as needed: accuracy (or trueness), precision (reproducibility and repeatability), detection capability, selectivity, reference range, and sample and reagent stability. We define these terms and present our approach to validation of several common flow cytometry assays, including examples of a leukemia/lymphoma assay and a paroxysmal nocturnal hemoglobinuria (PNH) assay.

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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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