Implementation of flow cytometry testing on rare matrix samples: Special considerations and best practices when the sample is unique or difficult to obtain

被引:1
作者
Devitt, Katherine A. [1 ,2 ]
Kern, Wolfgang [3 ]
Kajstura, Malgorzata A. [4 ]
Holl, Eda K. [5 ]
Hays, Amanda L. [6 ]
Hedley, Benjamin D. [7 ]
Gonneau, Christele [8 ]
Jellison, Evan R. [9 ]
McCloskey, Thomas W. [10 ]
Mishra, Shruti [11 ]
Rebeles, Jennifer [12 ]
Ouseph, Madhu M. [13 ]
机构
[1] Univ Vermont, Med Ctr, Dept Pathol & Lab Med, 111 Colchester Ave, Burlington, VT 05401 USA
[2] Univ Vermont, Larner Coll Med, Burlington, VT USA
[3] MLL Munich Leukemia Lab, Dept Flow Cytometry, Munich, Germany
[4] Univ Rochester Med Ctr, Dept Pathol & Lab Med, Rochester, NY USA
[5] Danaher Corp, Washington, DC USA
[6] BioAgilytix Labs, Sci Off, Durham, NC USA
[7] London Hlth Sci Ctr, Pathol & Lab Med, London, ON, Canada
[8] Labcorp Cent Labs Serv, Flow Cytometry Dept, Geneva, Switzerland
[9] UConn Sch Med, Dept Immunol, Farmington, CT USA
[10] ICON Lab Serv, Dept Res & Dev, Farmingdale, NY USA
[11] Banaras Hindu Univ, Bone Marrow Transplantat & Stem Cell Res Ctr, Inst Med Sci, Varanasi, Uttar Pradesh, India
[12] BioAffin Technol, Dept Diagnost, San Antonio, TX USA
[13] Weill Cornell Med, Dept Pathol & Lab Med, New York, NY USA
关键词
best practice; flow cytometry; quality; rare matrix; validation;
D O I
10.1002/cyto.b.22198
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The publication of Clinical and Laboratory Standards Institute's guideline H62 has provided the flow cytometry community with much-needed guidance on development and validation of flow cytometric assays (CLSI, 2021). It has also paved the way for additional exploration of certain topics requiring additional guidance. Flow cytometric analysis of rare matrices, or unique and/or less frequently encountered specimen types, is one such topic and is the focus of this manuscript. This document is the result of a collaboration subject matter experts from a diverse range of backgrounds and seeks to provide best practice consensus guidance regarding these types of specimens. Herein, we define rare matrix samples in the setting of flow cytometric analysis, address validation implications and challenges with these samples, and describe important considerations of using these samples in both clinical and research settings.
引用
收藏
页码:77 / 85
页数:9
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