CLSI EP17 A2 : 2ED 2012

Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Background
5 Protocols for Evaluation of the Limit of Blank
  and Limit of Detection
6 Protocol for Evaluation of the Limit of Quantitation
7 Verification of Detection Capability Claims
8 Reporting Detection Capability
References
Appendix A - Worked Example: Evaluation of Limits
             of Blank and Detection by the Classical
             Approach
Appendix B - Worked Example: Evaluation of Limit
             of Detection by the Precision Profile Approach
Appendix C - Worked Example: Evaluation of Limit
             of Detection by the Probit Approach
Appendix D - Worked Examples: Evaluation of Limit
             of Quantitation
Appendix E - Worked Example: Verification of Limits
             of Blank and Detection Claims
Appendix F - Worked Example: Verification of Limit
             of Quantitation Claim
The Quality Management System Approach
Related CLSI Reference Materials

Gives guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers' detection capability claims, and for the proper use and interpretation of different detection capability estimates.