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 for
Infectious Diseases
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 - Nucleic Acid Amplification Technologies
Summary of Consensus/Delegate Comments and Committee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications