Wayne, Pennsylvania, USA—November 2014—The Clinical and Laboratory Standards Institute (CLSI) has released a new document, Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline (C62-A). This document provides guidance to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. C62-A emphasizes particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry (MS) technology.
This document provides guidance for the development and verification of liquid chromatography-mass spectrometry (LC-MS) methods in the clinical laboratory.
C62-A is intended to serve not only as a companion to CLSI document Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline (C50-A), which serves as excellent general guidance for MS in the clinical laboratory, but also to provide an enhanced focus on methods, best practices, and instrumentation related to LC-MS, which is emerging as the most common approach to clinical analyses. This document is also intended to be a resource for instrument manufacturers, manufacturers of LC-MS reagents, regulatory agencies, and educators, as well as individuals responsible for developing laboratory standards and policy.
“This document will be useful as a guide for best practices in LC-MS method development and will provide a template for robust verification of LC-MS methods before implementation. Hopefully, the widespread implementation of this guideline will move the field toward harmonization of clinical LC-MS assays for various analytes,” notes William Clarke, PhD, MBA, DABCC, C62-A Document Development Committee Chairholder, and Associate Professor of Pathology and Director of Clinical Toxicology and Point-of-Care Testing at Johns Hopkins University of Medicine, Baltimore, Maryland, USA.
CLSI is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.