CLSI MM13 A : 1ED 2006

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Specimen Collection
  5.1 Analyte/Specimen Matrix
  5.2 Specimen Labeling and Collection
6 Specimen Transport and Storage
  6.1 General Recommendations for Transport
  6.2 General Recommendations for Storage of
      Purified DNA
  6.3 General Recommendations for RNA Studies
  6.4 Recommendations for Collection, Transport, and
      Storage of Specific Specimen Types
7 Sample Preparation
  7.1 Cell Enrichment/Selection
  7.2 Pathogen Enrichment and Concentration Methods
  7.3 Nucleic Acid Preparation
8 Sample Storage
  8.1 Storage Requirements - DNA
  8.2 Sample Storage Requirements - RNA
  8.3 Peripheral Blood Mononuclear Cell (PBMC)
      Cryopreservation
References
Additional References
Appendix A - Disruption of Tissue Samples Using Mortar
             and Pestle
Appendix B - PBMC Cryopreservation and Thawing Procedure
Summary of Consensus/Delegate Comments and Subcommittee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Defines general principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods.

This guideline describes general principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods. It is intended for all healthcare professionals responsible for obtaining and transporting specimens from patients or preparing samples for subsequent molecular tests. It is also intended for manufacturers of specimen collection devices and sample preparation reagents, kits, and instrumentation.In addition, this document describes specimen collection and transport devices, and sample preparation methods. Optimal storage conditions and special precautions for molecular methods are described. While this document is intended for diagnostic testing, it is possible that the principles described here may apply to other areas.NOTE: Measurand quality assessment should be undertaken at the level of the test method during method validation and is beyond the scope of this guideline. For information related to measurand (purified DNA or RNA) quality assessment, refer to the most current editions of the following CLSI/NCCLS documents: MM3—Molecular Diagnostic Methods for Infectious Diseases; MM5—Nucleic Acid Amplification Assays for Molecular Hematopathology; and/or MM9—Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine.