Establishment of measurement traceability for peptide and protein quantification through rigorous purity assessment—a review

Abstract The health of their populations and efficient health care systems are of critical importance to the economic and social well-being of nations. Accurate and comparable peptide/protein measurements are required in support of diagnosis, prognosis, monitoring and treatment of widespread diseases (e.g. diabetes). The required consistency of measurement results can be achieved by making them traceable to stated references and through the development of Reference Measurement Systems. The review mainly concentrates on the progress made in the Protein Analysis Working Group of the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM-PAWG) in establishing Primary Calibration Reference Services in the emerging area of health markers such as peptides/proteins. Primary Calibration Reference Services are technical capabilities for composition assignment, commonly as the mass fraction content, of pure substances or solutions thereof. It is a core technical competency for National Measurement Institutes (NMIs) . A limited number of key comparisons, foreseen by the CCQM-PAWG strategy, are discussed that enable NMIs providing measurement services in peptide/protein analysis to test and demonstrate their capabilities. In addition, the review examines the development and improvement of analytical methods and metrological models that are required to meet the needs of NMIs and associated clinical stakeholders.