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Liquid Chromatography-Mass Spectrometry Methods, 2nd Edition

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CLSI C62

Liquid Chromatography-Mass Spectrometry Methods, 2nd Edition

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. 

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Details

Chairholder: William Clarke, PhD, MBA, DABCC

Date of Publication: June 21, 2022

Order Code PDF: CLSI C62Ed2E
ISBN Number: 978-1-68440-155-0

Order Code Print: CLSI C62Ed2
ISBN Number: 978-1-68440-154-3

Edition: Second

Pages: 104

CLSI C62 Abstract

Clinical and Laboratory Standards Institute guideline C62—Liquid Chromatography-Mass Spectrometry Methods provides guidance for the development and verification of liquid chromatography-mass spectrometry (LC-MS) methods in the clinical laboratory. The document is intended to reduce interlaboratory variance for clinical assays through guidance for evaluating interferences, assay performance, and other pertinent characteristics. It 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 is intended for laboratorians responsible for development and verification of MS-based assays, physicians who may use these assays for patient care decisions, external quality assessment programs, and manufacturers of MS instrumentation and reagent kits designed to be paired with a particular mass spectrometer. This document is limited to discussion of LC-MS and is focused on the steps for development of a method, eg, whether the analyte is a drug, hormone, protein, or peptide.

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