scope:

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.