CLSI MM16 P : 1ED 2005

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
  4.1 Definitions
  4.2 Acronyms/Abbreviations
5 Overview
  5.1 Gene Expression Profiling Technology
  5.2 Gene Expression Profiling in Clinical Applications
  5.3 A Note on Technical Performance and Clinical
      Performance
6 External RNA Controls and Their Use in Expression Assays
  6.1 Internal and External RNA Controls in Gene Expression
      Assays
  6.2 Characteristics of External RNA Controls
  6.3 Using Control Materials to Assess Technical and
      Clinical Performance
  6.4 Limitations of External Controls
  6.5 Metrics for Assessing Technical Performance of the
      Expression Platform
7 Recommended Practices/Protocols
  7.1 Overview
  7.2 Protocols for Preparation and Assessment of External
      RNA Controls
  7.3 External RNA Control Protocols for Microarrays
  7.4 External RNA Control Protocols for QRT-PCR
References
The Quality System Approach
Related CLSI/NCCLS Publications

Describes the use of external RNA controls in microarray and QRT-PCR based gene expression experiments, including preparation of control transcripts, design of primers and amplicons, quality control, use in final experimental or clinical test application, and analysis and interpretation of data obtained.