CLSI MM6 A : 1ED 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
30-11-2010
12-01-2013
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
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