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CLSI MM9 A2 : 2ED 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
Available format(s)

Hardcopy , PDF

Superseded date

04-28-2023

Language(s)

English

Published date

02-28-2014

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Superseded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
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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
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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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