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Research ArticleResearch and Reports

Eight Steps to Method Validation in a Clinical Diagnostic Laboratory

Howard R. Baruch, Wael Hassan and Shashi Mehta
American Society for Clinical Laboratory Science January 2018, 31 (1) 43-47; DOI: https://doi.org/10.29074/ascls.2018000307
Howard R. Baruch
SHP-Rutgers University
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Wael Hassan
SHP-Rutgers University
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Shashi Mehta
SHP-Rutgers University
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Article Information

vol. 31 no. 1 43-47
DOI 
https://doi.org/10.29074/ascls.2018000307

Published By 
American Society for Clinical Laboratory Science
Print ISSN 
0894-959X
Online ISSN 
1945-3574
History 
  • Received April 1, 2018
  • Accepted April 5, 2018
  • Published online January 1, 2018.

Copyright & Usage 
© 2018 © 2018 The American Society for Clinical Laboratory Science American Society for Clinical Laboratory Science

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American Society for Clinical Laboratory Science: 31 (1)
American Society for Clinical Laboratory Science
Vol. 31, Issue 1
1 Jan 2018
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Eight Steps to Method Validation in a Clinical Diagnostic Laboratory
Howard R. Baruch, Wael Hassan, Shashi Mehta
American Society for Clinical Laboratory Science Jan 2018, 31 (1) 43-47; DOI: 10.29074/ascls.2018000307

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Eight Steps to Method Validation in a Clinical Diagnostic Laboratory
Howard R. Baruch, Wael Hassan, Shashi Mehta
American Society for Clinical Laboratory Science Jan 2018, 31 (1) 43-47; DOI: 10.29074/ascls.2018000307
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  • Article
    • LEARNING OBJECTIVES
    • ABSTRACT
    • INTRODUCTION
    • STATEMENT OF PRIMARY LABORATORY TEST OBJECTIVES
    • IDENTIFY THE KNOWN VARIABLES
    • APPLY APPROPRIATE STATISTICS
    • CLARIFY THE ANALYTE OF INTEREST AND METHOD SELECTION
    • SAMPLE SELECTION
    • DESCRIBE THE METHODS
    • PERFORMING DATA ANALYSIS
    • EXPLAINING THE RESULTS
    • SUMMARY
    • References
  • Figures & Data
  • Info & Metrics
  • PDF

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Keywords

  • CAP - College of American Pathologists
  • CLIA - Clinical Laboratory Improvement Amendments
  • CV - coefficient of variation
  • HbA1c - hemoglobin A1c
  • SD - standard deviation
  • SE - systematic error
  • SEa - allowable systematic error
  • RE - random error
  • TEa - total allowable error
  • method validation
  • precision
  • accuracy
  • linearity
  • correlation

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