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

Katherine A Devitt; Wolfgang Kern; Malgorzata A Kajstura; Eda K Holl; Amanda L Hays; Benjamin D Hedley; Christèle Gonneau; Evan R Jellison; Thomas W McCloskey; Shruti Mishra; Jennifer Rebeles; Madhu M Ouseph

doi:10.1002/cyto.b.22198

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

Cytometry B Clin Cytom. 2024 Jul 20. doi: 10.1002/cyto.b.22198. Online ahead of print.

Authors

Affiliations

¹ Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont, USA.
² Larner College of Medicine at the University of Vermont, Burlington, Vermont, USA.
³ Department of Flow Cytometry, MLL Munich Leukemia Laboratory, Munich, Germany.
⁴ Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, New York, USA.
⁵ Danaher Corporation, Washington, DC, USA.
⁶ Scientific Office, BioAgilytix Labs, Durham, North Carolina, USA.
⁷ Pathology and Laboratory Medicine, London Health Sciences Centre, London, Ontario, Canada.
⁸ Flow Cytometry Department, Labcorp Central Laboratories Services, Geneva, Switzerland.
⁹ Department of Immunology, UCONN School of Medicine, Farmington, Connecticut, USA.
¹⁰ Department of Research and Development, ICON Laboratory Services, Farmingdale, New York, USA.
¹¹ Bone Marrow Transplantation and Stem Cell Research Centre, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
¹² Department of Diagnostics, bioAffinity Technologies, San Antonio, Texas, USA.
¹³ Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.

PMID: 39032144
DOI: 10.1002/cyto.b.22198

Abstract

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.

Keywords: best practice; flow cytometry; quality; rare matrix; validation.