Many scientists performing preclinical and clinical research hit a point when they need to have an assay validated. You may have painstakingly developed and perfected a particular assay, but now you must put it through the rigors of validation for it to be considered a “validated assay.” The basic principles of assay validation were described in an earlier blog post, but how do you know you if you need an assay validated? Use these questions as a guide to help you figure out your validation situation and get a little less vexed about validation.

Flow cytometry is an elegant and powerful tool that has been critical to understanding the immune system and advancing the development of immune-based therapies. Critical to many studies, and essential for FDA filings, is the development and documentation of a validated assay. While most flow cytometric assays fall into the “quasi-quantitative” category according to FDA guidelines, there are some assays that can be quantitative and even qualitative.

The idiom, garbage in, garbage out applies to many areas of scientific research, including flow cytometry. Good sample preparation is critical to accurate and sensitive cytometry analysis of cells, wherever their origin. 

Flow cytometry assays are important for preclinical and clinical research, however, it is vital to understand the level of compliance required for the stage of research you are completing.  Flow Cytometry assays completed for toxicology and safety assessments are required to be in compliance of Good Laboratory Practices (GLP), on the other hand, basic research or discovery/exploratory studies can be non-GLP.  GLP refers to a set of standards for laboratory studies to be planned, performed, monitored, reported, and archived. Preclinical and clinical studies must be GLP-compliant in order to be submitted for review by regulatory agencies like the FDA. Consider these three points if you find yourself in need of a GLP-compliant flow cytometry assay. 

What is the primary role of Natural Killer (NK) cells? Natural killer (NK) cells are the predominant innate immune cells that mediate anti-tumor and anti-viral responses, and therefore possess good clinical utilization (Abel et al. 2018). Natural killer cells comprise 10–15% of peripheral blood lymphocytes and classically display a half-life of approximately 7–10 days in the circulation (Moretta et al. 2000).

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