scope:

This guideline describes general technical principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods. It is intended for all health care professionals responsible for obtaining and transporting specimens from patients or preparing samples for molecular tests. It is also intended for manufacturers of specimen collection devices and sample preparation reagents, kits, and instrumentation.

This guideline also describes specimen collection and transport devices, sample preparation methods and optimal storage conditions, and special precautions for molecular methods. Although this guideline is intended for diagnostic testing, the principles described here may apply to other areas.

MM13 also discusses QMS principles that should be implemented to meet regulatory and accreditation requirements. CLSI documents QMS01¹ and MM19² also provide thorough QMS implementation guidance.

For guidelines and best practices covering specimen collection, transport, handling, and storage safety, refer to CLSI document GP17³ and other available resources (eg, regulatory agencies,⁴ World Health Organization). International guidance is also available.⁵

For specimen handling information unique to specific technologies or subspecialties, consult CLSI documents MM03,⁶ MM05,⁷ MM09,⁸ and I/LA28.⁹

¹ CLSI. A Quality Management System Model for Laboratory Services. 5th ed. CLSI guideline QMS01. Clinical and Laboratory Standards Institute; 2019.

² CLSI. Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline. CLSI document MM19-A. Clinical and Laboratory Standards Institute; 2011.

³ CLSI. Clinical Laboratory Safety; Approved Guideline-Third Edition. CLSI document GP17-A3. Clinical and Laboratory Standards Institute; 2012.

⁴ US Department of Health and Human Services, Public Health Service, CDC, and National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 5th ed. HHS Publication No. (CDC) 21-1112. Washington, DC: US Department of Health and Human Services; 2009. Accessed 5 August 2020.

⁵ ISO. Medical laboratories - Requirements for safety. ISO 15190. Geneva, Switzerland: International Organization for Standardization; 2020.

⁶ CLSI. Molecular Diagnostic Methods for Infectious Diseases. 3rd ed. CLSI report MM03. Clinical and Laboratory Standards Institute; 2015.

⁷ CLSI. Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline-Second Edition. CLSI document MM05-A2. Clinical and Laboratory Standards Institute; 2012.

⁸ CLSI. Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline-Second Edition. CLSI document MM09-A2. Clinical and Laboratory Standards Institute; 2014.

⁹ CLSI. Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Edition. CLSI document I/LA28-A2. Clinical and Laboratory Standards Institute; 2011.