CLSI MM17 A : 1ED 2008

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View superseded by

VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS

Available format(s):

Superseded date: 27-03-2023

Language(s):

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
   4.1 Definitions
   4.2 Acronyms/Abbreviations
5 Sample Preparation
   5.1 Sample Types
   5.2 Manual Nucleic Acid Extraction
   5.3 Integrity
   5.4 Purity
   5.5 Open Automated Nucleic Acid Extraction
6 Target Amplification Technologies
   6.1 Target Amplification Technologies
   6.2 Particle-Based Signal Detection Technologies
   6.3 Signal Amplification Technologies
   6.4 Bioelectronic Array Detection of Deoxyribonucleic
        Acid (DNA) and Ribonucleic Acid (RNA) Hybrids
   6.5 Addressable Microarray
   6.6 Microfluidic Cards
7 Reference and Testing Materials
   7.1 Endogenous Nucleic Acid
   7.2 Whole Genome Amplification (WGA)
   7.3 Nongenomic Reference Materials (RMs)
   7.4 Internal Controls
   7.5 Studies to Validate That Internal Controls Are Functional
8 Analytic Verification and Validation
   8.1 Characterization and Presence of Reagent Components
   8.2 Technical Standard Operating Procedure (TSOP)
   8.3 Software and Algorithms
   8.4 Analytic Validation
   8.5 Analytic Validation of a Laboratory-Developed Assay (LDA)
   8.6 Analytic Verification of an In Vitro Diagnostic (IVD)
9 Data Analysis and Reporting of Results
   9.1 Types of Tests and Concomitant Data Requirements
   9.2 Genotype Calls
   9.3 Analysis of Analytical Study Results
   9.4 Analysis of Clinical Study Results
   9.5 Possible Limitations
10 Concluding Remarks
References
Additional References and Resources
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Abstract - (Show below) - (Hide below)

Provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes NCCLS MM17 P. (04/2008)
Document Type	Miscellaneous Product
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Superseded
Superseded By	CLSI MM17:2018
Supersedes	CLSI MM17 P : 1ED 2007

Standards Referenced By This Book - (Show below) - (Hide below)

CLSI EP19 : 2ED 2015	A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI MM9 A2 : 2ED 2014	NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
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 MM1 A3 : 3ED 2012	MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
CLSI POCT9 A : 1ED 2010	SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
CLSI MM22 A : 1ED 2014	MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
CLSI I/LA28 A2 : 2ED 2011	QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
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
CLSI MM6 A2 : 2ED 2010	QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
CLSI MM23 : 1ED 2015	MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
CLSI NBS05 A : 1ED 2011	NEWBORN SCREENING FOR CYSTIC FIBROSIS
CLSI QMS01 A4 : 4ED 2011	QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI MM21 : 1ED 2015	GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS
CLSI MM20 A : 1ED 2012	QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING
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 MM19 A : 1ED 2011	ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS

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

CLSI EP14 A2 : 2ED 2005	EVALUATION OF MATRIX EFFECTS
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
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 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 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 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 EP7 A2 : 2ED 2005	INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI MM3 A2 : 2ED 2006	MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
CLSI MM5 A : 1ED 2003	NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY

Categories associated with this Standard - (Show below) - (Hide below)

Sub-Categories associated with this Standard - (Show below) - (Hide below)

Sorry this product is not available in your region.

Add To Cart