CLSI EP10 A3 : 2006 + A1 2014

Abstract
Committee Membership
Summary of Changes in EP10 Amendment
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Materials
6 Calibration and Sequence of Samples in a Run
7 Number of Days and Runs
8 Preliminary Procedures
9 Collection and Recording of Data
10 Initial Data Plotting and Inspection
11 Analysis of the Data for Imprecision
12 Preliminary Assessment of Bias
13 Full Data Analysis Procedures
14 An Alternative Procedure
15 Use of EP10 by Manufacturers
16 How to Perform Multiple Regression for EP10
References
Symbols Used in Appendixes
Appendix A - Preliminary Performance Acceptability Check
Appendix B - Example Use of Data Sheets
Appendix C - Statistical Explanation
The Quality System Approach
Evaluation Protocols Documents, Descriptions, and Key Words

Before starting a complete evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, it is often necessary to make a preliminary decision about its acceptability.