CLSI MM10 P : 1ED 2005

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
The Quality System Approach
Related CLSI/NCCLS Publications

Specifies the analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting.