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CLSI MM10 A : 1ED 2006

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION

Withdrawn date

04-16-2019

Published date

01-12-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
   4.1 Definitions
   4.2 Abbreviations and Acronyms
5 Update on Technologies and Methodologies
   5.1 DNA Sequencing Technology
   5.2 SNP Analysis
   5.3 Differential Hybridization
   5.4 Restriction Fragment Length Polymorphism (RFLP)
   5.5 Amplified Fragment Length Polymorphism (AFLP)
   5.6 Single-Strand Conformational Polymorphism (SSCP)
        Analysis
   5.7 Denaturing High-Performance Liquid Chromatography
6 Sample Specifications and Handling
7 Standards, Controls, and Reference Materials
   7.1 Standards
   7.2 Controls
   7.3 Reference Materials
8 Analytical Verification and Validation
   8.1 Regulatory Considerations
   8.2 Analytical Verification
   8.3 Analytical Validation
   8.4 Clinical Considerations
   8.5 Conclusion
9 Reporting and Interpreting Results
   9.1 Methods of Interpretation
   9.2 Storage of Results
   9.3 Limitations and Significance
10 Quality Assurance
   10.1 Introduction
   10.2 Preanalytical Quality Assurance
   10.3 Analytical Quality Assurance
   10.4 Postanalytical Quality Assurance
References
Summary of Consensus/Delegate Comments and Committee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting.

DevelopmentNote
Supersedes NCCLS MM10 P (03/2006)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Withdrawn
Supersedes

CLSI MM18 A : 1ED 2008 INTERPRETIVE CRITERIA FOR IDENTIFICATION OF BACTERIA AND FUNGI BY DNA TARGET SEQUENCING
CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
CLSI MM17 P : 1ED 2007 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
CLSI MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
CLSI MM18 P : 1ED 2007 INTERPRETIVE CRITERIA FOR MICROORGANISM IDENTIFICATION BY DNA TARGET SEQUENCING<br>

CLSI M100 S16 : 16ED 2006 PERFORMANCE STANDARDS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING
CLSI EP12 A : 1ED 2002 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
CLSI M7 A7 : 7ED 2006 METHODS FOR DILUTION ANTIMICROBIAL SUSCEPTIBILITY TESTS FOR BACTERIA THAT GROW AEROBICALLY
CLSI MM6 A : 1ED 2003 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI EP10 A2 : 2ED 2002 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS
CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI MM9 A : 1ED 2004 NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
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 EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES

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