CLSI MM19 P : 1ED 2011

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS

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Superseded date: 30-11-2011

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Published date: 12-01-2013

Publisher: Clinical Laboratory Standards Institute

Table of Contents - (Show below) - (Hide below)

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Safety
6 Strategic Planning
7 Patient Samples and Nucleic Acid Extraction
8 Implementation Plan
9 Quality
10 Developing a Quality Management System
11 Unique Consideration for Different Laboratory
Specialties
References
Appendix A - Regulatory Requirements
Appendix B - Technology Overview and Platforms
Appendix C - Examples of Technology Available to Detect
Infectious Diseases
The Quality Management System Approach
Related CLSI Reference Materials

Abstract - (Show below) - (Hide below)

Gives comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.

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Document Type	Proposed Guideline
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Superseded
Superseded By	CLSI MM19 A : 1ED 2011

Standards Referencing This Book - (Show below) - (Hide below)

CLSI MM6 A2 : 2ED 2010	QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
CLSI EP5 A2 : 2ED 2004	EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI MM10 A : 1ED 2006	GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
CLSI EP12 A2 : 2ED 2008	USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
CLSI EP6 A : 1ED 2003	EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
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 GP40 A4 : 4ED 2006	PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
CLSI HS1 A2 : 2ED 2004	A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
CLSI EP15 A2 : 2ED 2006	USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI MM9 A : 1ED 2004	NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
CLSI MM1 A2 : 2ED 2006	MOLECULAR DIAGNOSTIC METHODS FOR GENETIC DISEASES
CLSI GP26 A3 : 3ED 2004	APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
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 MM12 A : 1ED 2006	DIAGNOSTIC NUCLEIC ACID MICROARRAYS
CLSI C24 A3 : 3ED 2006	STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI MM2 A2 : 2ED 2002	IMMUNOGLOBULIN AND T-CELL RECEPTOR GENE REARRANGEMENT ASSAYS
CLSI EP9 A2 : 2ED 2002	METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI MM3 A2 : 2ED 2006	MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
CLSI EP10 A3 : 2006 + A1 2014	PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI MM5 A : 1ED 2003	NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
CLSI GP2 A5 : 5ED 2006	LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL

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