Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
4.1 Definitions
4.2 Abbreviations and Acronyms
5 Update on Technologies and Methodologies
5.1 DNA Sequencing Technology
5.2 SNP Analysis
5.3 Differential Hybridization
5.4 Restriction Fragment Length Polymorphism (RFLP)
5.5 Amplified Fragment Length Polymorphism (AFLP)
5.6 Single-Strand Conformational Polymorphism (SSCP)
Analysis
5.7 Denaturing High-Performance Liquid Chromatography
6 Sample Specifications and Handling
7 Standards, Controls, and Reference Materials
7.1 Standards
7.2 Controls
7.3 Reference Materials
8 Analytical Verification and Validation
8.1 Regulatory Considerations
8.2 Analytical Verification
8.3 Analytical Validation
8.4 Clinical Considerations
8.5 Conclusion
9 Reporting and Interpreting Results
9.1 Methods of Interpretation
9.2 Storage of Results
9.3 Limitations and Significance
10 Quality Assurance
10.1 Introduction
10.2 Preanalytical Quality Assurance
10.3 Analytical Quality Assurance
10.4 Postanalytical Quality Assurance
References
Summary of Consensus/Delegate Comments and Committee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications