TY - JOUR TI - Analytical considerations and plans to standardize or harmonize assays for the reference bone turnover markers PINP and β-CTX in blood AU - Bhattoa, H.P. AU - Cavalier, E. AU - Eastell, R. AU - Heijboer, A.C. AU - Jørgensen, N.R. AU - Makris, K. AU - Ulmer, C.Z. AU - Kanis, J.A. AU - Cooper, C. AU - Silverman, S.L. AU - Vasikaran, S.D. JO - Clinica Chimica Acta PY - 2021 VL - 515 TODO - null SP - 16-20 PB - Elsevier B.V. SN - 0009-8981 TODO - 10.1016/j.cca.2020.12.023 TODO - C terminal telopeptide of type I collagen; peptides and proteins; procollagen type I N propeptide; unclassified drug; biological marker; collagen type 1; peptide; peptide fragment; procollagen, analytic method; Article; bone turnover; chemiluminescence immunoassay; electrochemiluminescence immunoassay; enzyme linked immunosorbent assay; immunoassay; manufacturing industry; practice guideline; priority journal; protein blood level; radioimmunoassay; standardization; bone remodeling; clinical trial; human; multicenter study, Biomarkers; Bone Remodeling; Collagen Type I; Humans; Peptide Fragments; Peptides; Procollagen TODO - Procollagen type I N-propeptide (PINP) and the C-terminal telopeptide of type I collagen (β-CTX) in blood have been designated as reference bone turnover markers in osteoporosis by the International Osteoporosis Foundation (IOF) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The IFCC Committee on Bone Metabolism (C-BM) has examined current commercial assays and performed a multicentre study to examine the agreement between assays for PINP and β-CTX in serum and plasma. The results of these studies will inform our work towards the harmonization of PINP assays and the standardization of β-CTX assays in blood, with the development of common calibrators and reference measurement procedures in collaboration with the reagent manufacturing industry. Successful achievement of these goals will help develop universally acceptable practice guidelines for the management of osteoporosis with the inclusion of common reference intervals and treatment targets for PINP and β-CTX. © 2020 Elsevier B.V. ER -