CLSI MM17 A : 1ED 2008

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

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