Devitt Katherine A, Oldaker Teri, Shah Kalpesh, Illingworth Andrea
Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont, USA.
Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.
Cytometry B Clin Cytom. 2023 Sep;104(5):374-391. doi: 10.1002/cyto.b.22123. Epub 2023 May 3.
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.
在临床实验室中，流式细胞术检测对于为临床治疗医生提供诊断和预后信息至关重要。验证或确认可确保该检测能产生可靠结果，从而值得信赖地用于做出关键医疗决策。实验室自行开发的检测的验证应根据需要包含以下性能规范：准确性（或真实性）、精密度（再现性和重复性）、检测能力、选择性、参考范围以及样本和试剂稳定性。我们定义这些术语，并介绍我们对几种常见流式细胞术检测进行验证的方法，包括白血病/淋巴瘤检测和阵发性夜间血红蛋白尿（PNH）检测的示例。
