Flow cytometry and other technologies of cell-based ﬂuorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often deﬁned with a soluble analyte in plasma or serum samples in mind. Recently the US Food and Drug Administration (FDA) has entered into a public dialogue in the US regarding their regulatory interest in laboratory developed tests (LDTs) or so-called “home brew” assays performed in clinical laboratories. The absence of well-deﬁned guidelines for validation of cell-based assays using ﬂuorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using ﬂow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to ﬂuorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS.
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