CLSI releases new edition of standard on quality control of microbiological transport systems

July 18, 2014

The Clinical and Laboratory Standards Institute (CLSI) has released a new edition of its document, Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition (M40-A2). This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.

The transport of clinical specimens is a critical component for accurate diagnosis. Preservation of inherent, interpretive attributes of microorganisms and/or nucleic acids can be quickly compromised when transport conditions or transport devices are suboptimal. M40 was updated because new data were generated from multiple studies that followed the recommendations provided in the previous edition, so the document now includes new and revised information, provides better definitions, and expands the sections on quality control (QC) of transport devices used for viruses, urine, and fecal specimens.

“This revised standard is critical to accurate diagnosis and facilitates that products meet the highest standards of laboratory practices,” notes M40-A2 Document Development Committee co-chairholders Paul Bourbeau, PhD, D(ABMM), BD Diagnostic Systems, and Paul L. Cerwinka, MSc, RM(AAM).

This edition of the document provides criteria to manufacturers and end users of transport devices to assist in providing and choosing dependable products for the transport of microbiological clinical specimens. It includes updated testing protocols that accommodate new types of swab collection devices, and better defines temperatures under which QC testing and specimen transport are conducted. The definitions section has been updated to contain additional information pertaining to swab types and transport and storage temperatures, and notes the difference between collection (sampling) devices and specimen collection and transport systems.

M40-A2 provides assurance to a device's user that manufacturer claims are met following standardized testing and acceptance criteria, and provides guidance to the manufacturer in addressing critical issues related to specimen integrity specific to the type of testing to be performed. The standard presents step-by-step directions for manufacturers’ QC and can be used for comparison and evaluation testing. Read sample pages.

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