CLSI C64

Quantitative Measurement of Proteins and Peptides by Mass Spectrometry, 1st Edition

This guideline describes the design, development, and validation of quantitative assays for proteins and peptides by mass spectrometry.

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Chairholder: Cory Bystrom, PhD

Date of Publication: May 5, 2021

Order Code PDF: CLSI C64Ed1E
ISBN Number: 978-1-68440-111-6

Order Code Print: CLSI C64Ed1
ISBN Number: 978-1-68440-110-9

Edition: First

Pages: 118

CLSI C64 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI C64 Abstract

Clinical and Laboratory Standards Institute guideline C64—Quantitative Measurement of Proteins and Peptides by Mass Spectrometry provides a framework for developing clinical protein and peptide assays from conception to validation. This guideline is intended for those who have experience with traditional small-molecule liquid chromatography–mass spectrometry (LC-MS) but not with protein and peptide analysis. Although closely related to traditional small-molecule analysis by LC-MS, protein and peptide analysis involves unique challenges and necessitates complex workflows, which are covered in detail. To enhance translation of assays to clinical use, this guideline focuses on method development aligned with clinically appropriate analytical validation.