CLSI MM3 P2 : 2ED 2005

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
   4.1 Definitions
   4.2 Abbreviations and Acronyms
5 Applications
   5.1 Utility of Molecular Diagnostic Tests
   5.2 Screening or Initial Testing
   5.3 Confirmatory and Supplemental Testing
6 Specimen Collection, Transport, and Processing
7 Contributors to False Negatives and Controls
   7.1 Detection of Inhibitors and Interfering
         Substances
   7.2 Inhibitory Samples
8 Methods
   8.1 Physical and Chemical Methods for Nucleic
         Acid Detection
   8.2 Detection Formats
   8.3 Nucleic Acid Amplification Technologies
   8.4 Real-Time PCR Instruments
9 Selection and Qualification of Nucleic Acid Sequences
   9.1 Target Region
   9.2 PCR Primer Sequence Selection
   9.3 Hybridization Probe Sequence Selection
   9.4 Fluorescent Resonance Energy Transfer (FRET)
         Probes
   9.5 Probe and Primer Forms and Purity
10 Establishment and Evaluation of Performance Characteristics
   of Molecular Diagnostic Tests
   10.1 Limit of Detection (Analytical Sensitivity)
   10.2 Analytical Specificity
   10.3 Precision
   10.4 Cutoff Values
   10.5 Diagnostic Sensitivity
   10.6 Diagnostic Specificity
   10.7 Predictive Values
   10.8 Diagnostic Accuracy
   10.9 Diagnostic Value
   10.10 Test Limitations
   10.11 Implementation of FDA-Cleared Tests
11 Quality Assurance
   11.1 Laboratory Design and Practices
   11.2 Instruments
   11.3 Quality Assurance (QA) During Development of Molecular
         Diagnostic Tests
   11.4 Control Materials
   11.5 Selecting Organism Strains for Analytical Studies
   11.6 Preparing Nucleic Acid Controls
   11.7 Types of Testing During Assay Development
   11.8 Quality Assurance (QA) for Implementation of Molecular
         Diagnostic Tests
12 Proficiency Testing
13 Controlling False-Positive Nucleic Acid Target Amplification
   Reactions
   13.1 Reagents and Solutions
   13.2 Laboratory Practice
   13.3 Selection and Preparation of Controls
   13.4 Amplification Product Inactivation Methods
14 Reporting of Results
   14.1 Organism and Nucleic Acid Target
   14.2 Equivocal Results
   14.3 Reference Range
   14.4 Critical Results
   14.5 Test Limitations
   14.6 Interpretation
   14.7 Clarifying Statements
15 Recommendations for Manufacturers and Clinical Laboratories
   15.1 Regulatory Requirements
   15.2 Recommendations to Assay Developers
   15.3 Recommendations for Clinical Laboratories
   15.4 Selection of Referral Laboratories
References
Additional References
Appendix A. Nucleic Acid Amplification Technologies
Summary of Consensus Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Describes the clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories.