CLSI MM6 A : 1ED 2003

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
   3.1 Definitions
   3.2 Abbreviations and Acronyms
4 Update on Technologies Used in Molecular Quantitation
5 Specimen Handling and preparation for Quantitation of
   Nucleic Acid
   5.1 Specimen collection
   5.2 Specimen Transport and Storage
   5.3 Specimen Processing
6 Standards, Calibrations, and Reference Materials
   6.1 Quantitated Analytical Standards
   6.2 Reference Materials
   6.3 Calibrations
7 Analytical Verification
   7.1 General Considerations
   7.2 Precision
   7.3 Linearity and Measuring Range
   7.4 Trueness
   7.5 Limit of Detection, Limit of Quantitation
   7.6 Analytical Specificity
   7.7 Interfering Substances
8 Clinical Validation
   8.1 Introduction
   8.2 Clinical Question
   8.3 Clinical Performance
   8.4 Correlation to Disease or Condition
   8.5 Comparison to Current Methods/Standards
   8.6 Outcome Measurement
9 Reporting and Interpretation of Results
   9.1 Units
   9.2 Significant Figures
   9.3 Transformation
   9.4 Sequential Tests
   9.5 Results Outside of the Measuring Range
10 Continuing Quality Assurance
   10.1 Introduction
   10.2 Preanalytical Phase
   10.3 Analytical Phase
   10.4 Postanalytical Phase Quality Assurance
11 Clinical Utility
   11.1 Section Goals
   11.2 Clinical Indications
   11.3 Variables
   11.4 Indications Pertaining to Detection of Infection
        and Outcome of Infection
References
Additional References
Appendix Technologies Used in Molecular Quantitation
Summary of Comments and Subcommittee Responses
Summary of Delegate Comments and Subcommittee Responses
The Quality System Approach
Related NCCLS Publications

Gives guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms.