Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations

David Barnett, Raaul Louzao, Peter Gambell, Jitakshi De, Teri Oldaker, Curtis A. Hanson

Research output: Contribution to journalReview articlepeer-review

38 Scopus citations


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 U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. 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 - Part IV - Postanalytic considerations.

Original languageEnglish (US)
Pages (from-to)309-314
Number of pages6
JournalCytometry Part B - Clinical Cytometry
Issue number5
StatePublished - Sep 1 2013


  • Cellular Analysis
  • Flow Cytometry
  • Qualitative Assays
  • Quality Assessment
  • Quality Control
  • Quantitative Assays

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology
  • Cell Biology


Dive into the research topics of 'Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations'. Together they form a unique fingerprint.

Cite this