Chapter 2. Hemostasis Test Validation, Performance and Reference Intervals

  1. Steve Kitchen PhD Clinical Scientist Scientific Director3,4,5,
  2. John D. Olson MD, PhD Professor Vice Chair for Clinical Affairs6,
  3. F. Eric Preston MD, FRCPath, FRCP Emeritus Professor of Hematology Director7,8
  1. R. A. Marlar PhD1,2

Published Online: 4 MAR 2009

DOI: 10.1002/9781444303575.ch2

Book Title

Quality in Laboratory Hemostasis and Thrombosis

Quality in Laboratory Hemostasis and Thrombosis

Additional Information

How to Cite

Marlar, R. A. (2009) Hemostasis Test Validation, Performance and Reference Intervals, in Quality in Laboratory Hemostasis and Thrombosis (eds S. Kitchen, J. D. Olson and F. E. Preston), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444303575.ch2

Editor Information

  1. 3

    Sheffield Hemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, UK

  2. 4

    UK National External Quality Assessment Scheme (EQAS) for Blood Coagulation, Sheffield, UK

  3. 5

    WHO and WFH International External Quality Assessment Programs for Blood Coagulation, Sheffield, UK

  4. 6

    Department of Pathology, University of Texas Health Science Center, San Antonio, Texas, USA

  5. 7

    University of Sheffield, Sheffield, UK

  6. 8

    WHO and WFH International External Quality Assessment Programs for Blood Coagulation, Rutledge Mews, Sheffield, UK

Author Information

  1. 1

    Pathology and Laboratory Medicine, Oklahoma City VA Medical Center, Oklahoma City, Oklahoma, USA

  2. 2

    Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

Publication History

  1. Published Online: 4 MAR 2009
  2. Published Print: 19 DEC 2008

ISBN Information

Print ISBN: 9781405168038

Online ISBN: 9781444303575

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CHAPTER TOOLS

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Keywords:

  • clinical hemostasis laboratory and validation, performance, reference intervals;
  • hemostatic test validation concepts;
  • validating test methods - ensuring high quality data for accurate diagnosis of disease;
  • precision and closeness of agreement;
  • hemostasis assay performance;
  • reference interval;
  • new reference interval for new tests or changes in methodology – costly and challenging

Summary

This chapter contains sections titled:

  • Hemostatic tests validation concepts

  • Performance of hemostasis assays

  • Reference interval

  • Acknowledgments

  • References

  • Appendix

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