CLSI EP12 A2 : 2ED 2008

Abstract
Committee Membership
Foreword
Laboratory Error Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Clinical Utility
   4.1 Screening Tests
   4.2 Diagnostic Tests
   4.3 Confirmatory Tests
5 Terminology
   5.1 A Note on Terminology
   5.2 Terms for Comparative Benchmark
   5.3 Definitions
6 Device Familiarization and Training
   6.1 Purpose
   6.2 Duration
7 Evaluation Materials
   7.1 Controls
   7.2 Specimen Collection and Handling
8 Bias and Imprecision Studies
   8.1 Analyte Concentrations Near the Cutoff
   8.2 Negative and Positive Controls
   8.3 A Qualitative Method-Precision Experiment for Analyte
        Concentrations Near the C[50]
9 Comparison of Methods
   9.1 Test Specimens
   9.2 Number of Specimens
   9.3 Duration
   9.4 Inspection of Data During Collection
   9.5 Discrepant Results
   9.6 Reference Specimen Panels
10 Data Analysis
   10.1 Comparator Is Diagnostic Accuracy Criteria
   10.2 Comparator Other Than Diagnostic Accuracy Criteria
   10.3 Examples
References
Appendix - Statistical Reasoning for Precision Experiment
           Conclusions
Summary of Consensus Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality Management System Approach
Evaluation Protocols Documents, Descriptions, and Key Words

Provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests.