CLSI MM19 A : 1ED 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
Hardcopy , PDF
English
30-11-2011
22-11-2025
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 Management System
10 Developing a Quality Management System
11 Unique Considerations 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
Specifies 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.
| DevelopmentNote |
Supersedes CLSI MM19 P. (12/2011)
|
| DocumentType |
Standard
|
| ISBN |
1-56238-773-1
|
| Pages |
252
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI MM23 : 1ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS) |
| CLSI MM9 A2 : 2ED 2014 | NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
| CLSI MM21 : 1ED 2015 | GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS |
| CLSI MM5 A2 : 2ED 2012 | NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
| 17/30331313 DC : 0 | BS EN ISO 20186-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA CORRECT |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| CLSI MM20 A : 1ED 2012 | QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| 17/30326658 DC : 0 | BS EN ISO 20186-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA |
| CLSI MM23:2025 | Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) |
| ISO 15195:2003 | Laboratory medicine — Requirements for reference measurement laboratories |
| CLSI POCT4 A2 : 2ED 2006 | POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING |
| CLSI MM16 A : 1ED 2006 | USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS |
| ISO 15193:2009 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| 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 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 |
| ISO 15189:2007 | Medical laboratories — Particular requirements for quality and competence |
| CLSI MM14 A : 1ED 2005 | PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| ISO 17511:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials |
| ISO 9000:2005 | Quality management systems — Fundamentals and vocabulary |
| CLSI GP40 A4 : 4ED 2006 | PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY |
| 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 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 M55 R : 1ED 2010 | SURVEILLANCE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS: PRINCIPLES, PRACTICES, AND CHALLENGES |
| 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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