Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
4.1 A Note on Terminology
4.2 Definitions
4.3 Abbreviations/Acronyms
5 Establishment of Analytical Performance
5.1 Assay Components
5.2 Specimen Requirements
5.3 Assay Design Criteria
6 Clinical Evaluation: Planning and Design
6.1 Investigator's Manual
6.2 Ethical Considerations
6.3 Clinical Evaluation Protocol
6.4 Clinical Evaluation Objectives
6.5 Selection of Investigator and Evaluation Site
6.6 Evaluating Performance Characteristics
6.7 Study Population
7 Conducting the Clinical Evaluation
7.1 Monitoring Clinical Evaluations
7.2 Database Management
7.3 Quality Assurance of Data Integrity
7.4 Retention of Records
8 Analysis of Clinical Evaluation Data
8.1 Performance of Statistical Tests
8.2 Documentation of Performance Characteristics
8.3 Clinical Evaluation Summary
References
Additional References
Appendix - 95% Confidence Ranges for 0.98 Sensitivity
and 0.98 Specificity
Summary of Consensus Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality Management System Approach
Related CLSI Reference Materials