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EP09A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples Approved Guideline Third Edition by Budd ISBN 1-56238-887-8

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EP09A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples Approved Guideline Third Edition J. R. Budd Digital Instant Download

Author(s): J. R. Budd, A.P. Durham, T.E. Gwise, B Iriarte, A. Kallner, K. Linnet, R. Magari, J.E. Vaks, Clinical and Laboratory Standards Institute
ISBN(s): 9781562388881, 1562388886
Edition: Third Edition
File Details: PDF, 3.33 MB
Year: 2013
Language: english
SKU: EB-5763024 Category: Tags: , , , , , , , ,

EP09A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples Approved Guideline – Ebook PDF Instant Download/Delivery:  1-56238-887-8
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Product details: 

ISBN 10:  1-56238-887-8

Author:  J. R. Budd 

Clinical and Laboratory Standards Institute document EP09-A3—Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition is written for laboratorians and manufacturers. It describes procedures for determining the bias between two measurement procedures, and it identifies factors for consideration when designing and analyzing a measurement procedure comparison experiment using split patient samples. An overview of the measurement procedure comparison experiment includes considerations for both manufacturers and laboratorians. Details on how to create difference and scatter plots for visual inspection of the data are provided. Once the data are characterized, various methods are introduced for quantifying the relationship between two measurement procedures, including bias estimates and regression techniques. The final section contains recommendations for manufacturers’ evaluation of bias and statement format for bias claims

Table of contents: 

Scope

Introduction

  • Overview of the Measurement Procedure Comparison Study
  • Primary Purposes for Measurement Procedure Comparisons

Standard Precautions

Terminology

  • A Note on Terminology
  • Definitions
  • Symbols Used in the Text
  • Abbreviations and Acronyms

Measurement Procedure–Familiarization Period

Measurement Procedure Comparison Studies

  • Study Samples
  • Comparative Measurement Procedure
  • Number of Samples
  • Factors Affecting the Measurement Procedure Comparison
  • Sample Sequence
  • Time and Duration
  • Inspection of Data During Collection
  • Quality Control
  • Documentation of Rejected Data

Considerations for Clinical Laboratories

  • Comparative Measurement Procedure
  • Number of Samples
  • Calibration and Procedure Control

Visual Data Review

  • Scatter Plots
  • Difference Plots
  • Inspect Plots for Underlying Characteristics

Quantitative Analysis

  • Estimating Bias From Difference Plots
  • Fitting a Line to Scatter Plots (Regression Analysis)
  • Bias and Regression Parameters With Confidence Intervals

Comparisons Within a Measurement Procedure

  • Sample Type Comparisons
  • Other Comparisons

Interpreting Results and Comparing to Performance Criteria

Contents (Continued)

  • Manufacturer’s Statement of Bias Performance Claims
  • Laboratory’s Statement of Bias Performance

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J. R. Budd,EP09A3 Measurement,Procedure Comparison,Bias Estimation