CLSI MM12 P : 1ED 2005

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
   2.1 Diagnostic Microarrays
   2.2 Diagnostic Utility
   2.3 Advantages and Disadvantages
   2.4 Ethical, Legal, and Social Considerations
   2.5 Special Issues for Application of Microarray
        Technologies to Diagnosis
3 Standard Precautions
4 Terminology
   4.1 Definitions
   4.2 Acronyms/Abbreviations
5 Method Overview
   5.1 Solid Supports
   5.2 Probe Synthesis and Attachment to Support
   5.3 Signal Generation and Detection
6 Analytical
   6.1 Nucleic Acid Extraction
   6.2 Gene Chemistry
   6.3 Hybridization
   6.4 Posthybridization
   6.5 Signal Generation and Detection
   6.6 Laboratory-developed ("Home-Brew") Microarray
        Assay
7 Genetic Data Analysis
   7.1 Data Elements
   7.2 Heritable Changes
   7.3 Methylation Analysis
   7.4 Pathogen Profiling
   7.5 Detection of Gene Dosage Abnormalities Using
        Comparative Genomic Hybridization
8 Gene Expression Data Analysis
   8.1 Overview
   8.2 Data Elements
   8.3 Low-Level Analysis
   8.4 Gene Filtering and Identification of Differentially
        Expressed Genes
   8.5 High-Level Data Analysis - Unsupervised Learning
        Algorithms
   8.6 High-Level Data Analysis - Supervised Learning and
        Classification Procedures
9 Validation
   9.1 Analytical Validation
   9.2 Diagnostic Utility
10 Quality Control/Quality Assurance
   10.1 Preanalytical Considerations
   10.2 Analytical Phases
   10.3 Global QC Issues
   10.4 Reporting
   10.5 Quality Assurance (QA)
References
The Quality System Approach
Related CLSI/NCCLS Publications

Describes the recommendations for many aspects of the array process including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; quality control; analytic validation; and interpretation and reporting of results.