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CLSI MM6 A2 : 2ED 2010

Current
Current

The latest, up-to-date edition.

QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2010

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Update on Molecular Quantification Technologies
6 Specimen Handling and Preparation for Molecular
   Quantification
7 Reference Materials, Standards, Calibrators, and
   Quality Control Materials
8 Analytical Versification and Validation
9 Clinical Validity and Clinical Utility
10 Reporting, Interpretation, and Limitations of results
11 Continuing Quality Assurance
References
Appendix - timing of Specimen Collection
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

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.

DevelopmentNote
Supersedes NCCLS MM6 A. (05/2011)
DocumentType
Standard
ISBN
1-56238-736-7
Pages
76
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

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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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CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
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Hardcopy - English
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