Ad hoc antibody modification of a validated flow cytometric immunophenotyping panel-recommendations and safeguards for clinical laboratories.

IF 2.7 3区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY
Christopher J Groves, Michael A Linden, Ahmad Al-Attar, Michael J Borowitz, Christoph Eberle, Marci O'Driscoll, Eleni Linskens, Jolene Cardinali, Thomas C Beadnell, Wendy Shallenberger, Xiangyang Dong, Robert J Durso, Sara A Monaghan, Benjamin D Hedley
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引用次数: 0

Abstract

Immunophenotyping by flow cytometry is a valuable test providing important information in a timely manner. In clinical laboratories, it is performed using validated antibody panels designed to ensure consistent and accurate results. However, unforeseen situations, such as unique or unusual immunophenotypes, or supply chain issues, may necessitate ad hoc modifications to these panels. This manuscript provides guidance for performing minor modifications, such as substituting or adding one or two antibodies, while maintaining the integrity of the assay. These modifications are intended for rare clinical situations and are not substitutes for the full validation protocols outlined in CLSI H62. An example of this would be a patient with a rare, but not uncommon, situation in which a B cell lymphoma lacks expression of CD19, CD20, and surface light chains, such that the lineage of the neoplastic cells cannot be determined without a straightforward addition or substitution of another marker into a laboratory's available panel. The recommendations and best practices herein aim to optimize patient care by allowing laboratories to adapt to unique clinical scenarios without compromising assay performance and are not a way to permanently modify the assay. Key considerations include assessing the impact on fluorescence compensation, antibody binding, assay sensitivity, and overall assay performance. The manuscript provides limitations for the extent of modifications, examples, and troubleshooting strategies to ensure reliable results when ad hoc changes are made. Proper documentation with review and approval by laboratory medical directors is recommended to mitigate risks associated with these modifications.

经过验证的流式细胞术免疫表型组的特设抗体修饰-临床实验室的建议和保障措施。
流式细胞术免疫分型是一种及时提供重要信息的有价值的检测方法。在临床实验室中,使用经过验证的抗体板进行检测,以确保结果一致和准确。然而,不可预见的情况,如独特或不寻常的免疫表型,或供应链问题,可能需要对这些面板进行特别修改。本手稿提供了进行微小修改的指导,例如替换或添加一或两个抗体,同时保持检测的完整性。这些修改用于罕见的临床情况,不能替代CLSI H62中概述的完整验证方案。一个罕见但并不罕见的例子是,B细胞淋巴瘤缺乏CD19、CD20和表面轻链的表达,因此,如果不直接在实验室可用的面板中添加或替换另一种标记物,就无法确定肿瘤细胞的谱系。此处的建议和最佳实践旨在通过允许实验室适应独特的临床场景而不影响分析性能来优化患者护理,而不是永久修改分析的方法。主要考虑因素包括评估对荧光补偿、抗体结合、测定灵敏度和总体测定性能的影响。手稿提供了修改程度的限制,示例和故障排除策略,以确保在进行临时更改时获得可靠的结果。建议提供适当的文件,并经实验室医务主任审查和批准,以减轻与这些修改相关的风险。
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
CiteScore
6.80
自引率
32.40%
发文量
51
审稿时长
>12 weeks
期刊介绍: Cytometry Part B: Clinical Cytometry features original research reports, in-depth reviews and special issues that directly relate to and palpably impact clinical flow, mass and image-based cytometry. These may include clinical and translational investigations important in the diagnostic, prognostic and therapeutic management of patients. Thus, we welcome research papers from various disciplines related [but not limited to] hematopathologists, hematologists, immunologists and cell biologists with clinically relevant and innovative studies investigating individual-cell analytics and/or separations. In addition to the types of papers indicated above, we also welcome Letters to the Editor, describing case reports or important medical or technical topics relevant to our readership without the length and depth of a full original report.
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