9. Evaluation of Hematology Analyzers

  1. Kandice Kottke-Marchant MD, PhD2,3,4 and
  2. Bruce H. Davis MD5
  1. Carol Briggs BSc, FIBMS

Published Online: 8 AUG 2012

DOI: 10.1002/9781444398595.ch9

Laboratory Hematology Practice

Laboratory Hematology Practice

How to Cite

Briggs, C. (2012) Evaluation of Hematology Analyzers, in Laboratory Hematology Practice (eds K. Kottke-Marchant and B. H. Davis), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444398595.ch9

Editor Information

  1. 2

    Pathology & Laboratory Medicine Institute, Cleveland, OH, USA

  2. 3

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

  3. 4

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

  4. 5

    Trillium Diagnostics, LLC, Bangor, ME, USA

Author Information

  1. Department of Haematology, University College London Hospitals, London, UK

Publication History

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

ISBN Information

Print ISBN: 9781405162180

Online ISBN: 9781444398595

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Keywords:

  • hematology analyzer;
  • instrument evaluation;
  • instrument validation;
  • carryover;
  • precision;
  • linearity;
  • comparability;
  • sample stability;
  • reference ranges;
  • point-of-care testing devices;
  • hematology quality control

Summary

The requirements for evaluation of hematology instruments depend upon the information already available. If a complete national evaluation has not been performed the purchaser need only perform a literature search to find independent peer-reviewed evaluations. When this information is available the local user would not be expected to perform a full evaluation. However, purchasing any hematology analyzer without at least a limited evaluation of its performance and a validation of results is not recommended. This chapter describes a comprehensive evaluation protocol that gives an indication of the information needed prior to selection and implementation of a new analyzer into routine service. Guidance is also provided for conducting local evaluations. The performance attributes of any analyzer should be ascertained in the specific environment where the instrument will be sited and by the staff who will be operating the instrument. Special considerations for evaluation of point-of-care instruments are also discussed.