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Flow Cytometry

Flow Cytometry

The development of flow cytometry techniques began in 1934 with initial attempts by Andrew Moldavan, a bacteriologist who counted the cells in a flowing capillary system. Moldavan pumped cells through a capillary tube focused under a microscope for visualization. The invention of photometry allowed the measurement of differentially-stained cells, and Louis Kamentsky developed the first multiparameter flow cytometer in 1965 to identify and count the cancer cells in cervical tissue specimens.
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Related Experiment Video

Updated: Jul 18, 2025

A Flow Cytometry-Based Cell Surface Protein Binding Assay for Assessing Selectivity and Specificity of an Anticancer Aptamer

A Flow Cytometry-Based Cell Surface Protein Binding Assay for Assessing Selectivity and Specificity of an Anticancer Aptamer

Published on: September 13, 2022

Flow Cytometry Method Validation Protocols.

Nithianandan Selliah¹, Veronica Nash¹, Steven Eck²

¹Cerba Research, Lake Success, New York.

Current Protocols

|August 22, 2023

Summary

This summary is machine-generated.

This study introduces four analytical method validation protocols for cellular analysis using flow cytometry, ensuring credible and reproducible data in various laboratory settings. These fit-for-purpose approaches cater to research, biopharma, and clinical diagnostics.

Keywords:

biomarker fit-for-purpose validation flow cytometry precision sensitivity

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Last Updated: Jul 18, 2025

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Published on: March 24, 2023

Area of Science:

Biotechnology
Analytical Chemistry
Cellular Biology

Background:

Analytical method validation is crucial for ensuring data credibility and reproducibility.
Flow cytometry is a key technique in cellular analysis, requiring robust validation.
Existing validation guidelines may not cover all specific applications, necessitating tailored approaches.

Purpose of the Study:

To introduce four distinct analytical method validation protocols for flow cytometry.
To provide practical procedures for different laboratory settings and validation needs.
To promote a fit-for-purpose validation strategy based on intended assay use.

Main Methods:

Development of four basic protocols for analytical method validation in flow cytometry.
Protocol 1: Limited validation for research and non-regulated labs.
Protocol 2: Fit-for-purpose validation for biopharma and research.
Protocol 3: Validation for moderate-risk clinical laboratory-developed tests.
Protocol 4: Transfer validation between facilities.

Main Results:

Four distinct validation protocols are presented, ranging from limited to transfer validation.
All protocols emphasize a fit-for-purpose approach, tailoring validation to the assay's intended use.
The protocols are designed to be minimal requirements, adaptable for various applications.

Conclusions:

The presented protocols offer a framework for validating flow cytometry methods across diverse settings.
Adoption of these fit-for-purpose validation strategies enhances data reliability.
These recommendations align with established guidelines from professional organizations and CLSI.