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. This guideline emphasizes particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry technology.
CLSI C62
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Liquid Chromatography-Mass Spectrometry Methods, 2nd Edition
Clinical and Laboratory Standards Institute , 06/21/2022