11. Validation and Quality Control in Clinical Flow Cytometry

  1. Kandice Kottke-Marchant MD, PhD3,4,5 and
  2. Bruce H. Davis MD6
  1. Norman B. Purvis Jr. PhD1 and
  2. Teri Oldaker MLS (ASCP), QCYM2

Published Online: 8 AUG 2012

DOI: 10.1002/9781444398595.ch11

Laboratory Hematology Practice

Laboratory Hematology Practice

How to Cite

Purvis, N. B. and Oldaker, T. (2012) Validation and Quality Control in Clinical Flow Cytometry, in Laboratory Hematology Practice (eds K. Kottke-Marchant and B. H. Davis), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444398595.ch11

Editor Information

  1. 3

    Pathology & Laboratory Medicine Institute, Cleveland, OH, USA

  2. 4

    Department of Pathology, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA

  3. 5

    Hemostasis and Thrombosis, Department of Clinical Pathology, Cleveland Clinic, Cleveland, OH, USA

  4. 6

    Trillium Diagnostics, LLC, Bangor, ME, USA

Author Information

  1. 1

    Nodality, Inc., South San Francisco, CA, USA

  2. 2

    Genoptix Medical Laboratory, Carlsbad, CA, USA

Publication History

  1. Published Online: 8 AUG 2012
  2. Published Print: 10 APR 2012

ISBN Information

Print ISBN: 9781405162180

Online ISBN: 9781444398595



  • photomultiplier tube (PMT);
  • optimization;
  • standardization;
  • lymphocytes;
  • control


Immunophenotyping by flow cytometry plays a crucial role in many aspects of medical hematology and has replaced many traditional manual procedures. Many of these procedures are critical to clinical decisions in areas of hematopathology, infectious disease, and transplant medicine. Though more sensitive and accurate, there are many variables that can impact flow cytometry results and must be controlled in a comprehensive quality control and quality assurance program. These variables include: the collection, transportation, and sample handling to maintain optimum sample integrity; the instrument set-up and performance; the reagent performance (specifically monoclonal antibodies); and the acquisition and analysis of the generated data. This chapter will review the initial optimization and validation of clinical flow cytometry assays (both with respect to instrumentation and reagents). In addition, details will be provided for the monitoring and maintenance of the assay specifications (precision and accuracy) to ensure that high quality, reliable, and reproducible results are reported.