CLSI MM3 A3 : 3ED 2015
Current
The latest, up-to-date edition.
MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
27-02-2015
Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Applications
Chapter 3 - Specimen Collection, Transport, and
Processing
Chapter 4 - Contributors to False-Negative Results and Controls
Chapter 5 - Methods
Chapter 6 - Selection and Qualification of Nucleic Acid Sequences
Chapter 7 - Establishment and Evaluation of Performance
Characteristics of Molecular Diagnostic Tests
Chapter 8 - Quality Assurance
Chapter 9 - Reporting of Results
Chapter 10 - Recommendations for Manufactures and Clinical
Laboratories
Chapter 11 - Conclusion
Chapter 12 - Supplemental Information
References
Additional References
Appendix Nucleic Acid Amplification Technologies
The Quality Management System Approach
Related CLSI References Materials
Defines general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture.
| DevelopmentNote |
Supersedes CLSI MM3 A2. (03/2015)
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| DocumentType |
Standard
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| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Current
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| Supersedes |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
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