CLSI publishes new document C64 – Quantitative Measurement of Proteins and Peptides by Mass Spectrometry, 1st edition
The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of C64 – Quantitative Measurement of Proteins and Peptides by Mass Spectrometry. C64 provides a framework for developing clinical protein and peptide assays from conception to validation and 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.
This guideline also discusses:
• Effective use of internal standards.
• Quality control and proficiency testing
• Feasibility determination and planning.
• Approaches to calibration.