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. The 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 the CLSI document Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline (C50-A), which serves as 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. 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. Read sample pages.Read more