CLSI MM9 A2 : 2ED 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
Hardcopy , PDF
28-04-2023
English
28-02-2014
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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Technologies and Applications
6 Specimen Collection, Storage, Transport, and
Preparation for Analysis
7 Template Preparation
8 Sequence Generation and Potential Artifacts
9 Sequence Alignment, Assembly, and Evaluation
10 Validation and Verification
11 Ongoing Quality Assurance and Quality Control
12 Interpreting and Reporting Results
References
Appendix - Example of Troubleshooting Guide for
Sequencing Assays
The Quality Management System Approach
Related CLSI Reference Materials
Specifies diagnostic sequencing using both automated capillary-based sequencers and massively parallel sequencing instruments.
| DevelopmentNote |
Supersedes CLSI MM9 A. (03/2014)
|
| DocumentType |
Miscellaneous Product
|
| ISBN |
1-56238-954-8
|
| Pages |
140
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| 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 |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| ANSI/AAMI/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 |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI MM23 : 1ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS) |
| CLSI MM21 : 1ED 2015 | GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS |
| CLSI GP27 A2 : 2ED 2007 | USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY |
| CLSI MM19 A : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI QMS12 A : 1ED 2010 | DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY |
| CLSI MM5 A2 : 2ED 2012 | NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
| CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI MM18 A : 1ED 2008 | INTERPRETIVE CRITERIA FOR IDENTIFICATION OF BACTERIA AND FUNGI BY DNA TARGET SEQUENCING |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| CLSI MM14 A2 : 2ED 2013 | DESIGN OF MOLECULAR PROFICIENCY TESTING/EXTERNAL QUALITY ASSESSMENT |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI MM1 A3 : 3ED 2012 | MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING |
| CLSI QMS11 A : 1ED 2007 | MANAGEMENT OF NONCONFORMING LABORATORY EVENTS |
| CLSI MM20 A : 1ED 2012 | QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING |
| CLSI MM13 A : 1ED 2006 | COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS |
| CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| CLSI MM3 A2 : 2ED 2006 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI QMS06 A3 : 3ED 2011 | QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT |
| CLSI QMS02 A6 : 6ED 2013 | QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS |
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