TY - JOUR
T1 - Analytical considerations and plans to standardize or harmonize assays for the reference bone turnover markers PINP and β-CTX in blood
AU - Bhattoa, Harjit P.
AU - Cavalier, Etienne
AU - Eastell, Richard
AU - Heijboer, Annemieke C.
AU - Jørgensen, Niklas R.
AU - Makris, Konstantinos
AU - Ulmer, Candice Z.
AU - Kanis, John A.
AU - Cooper, Cyrus
AU - Silverman, Stuart L.
AU - Vasikaran, Samuel D.
N1 - Funding Information: EC is a consultant for Diasorin, IDS, Fujirebio, bioMerieux, Menarini and Nittobo. RE receives consultancy funding from IDS, Roche Diagnostics, GSK Nutrition, FNIH, Mereo, Lilly, Sandoz, Nittobo, Abbvie, Samsung, Haoma Medica, CL Bio, and Viking and grant funding from Nittobo, IDS, Roche, Amgen and Alexion. NRJ has received free reagents for research use from Roche Diagnostics and IDS. JAK reports grant support from Amgen, Lilly and Radius Health. CC has received lecture fees and honoraria from Amgen, Danone, Eli Lilly, GSK, Kyowa Kirin, Medtronic, Merck, Nestlé, Novartis, Pfizer, Roche, Servier, Shire, Takeda and UCB outside of the submitted work. SLS has received grant support from Roche, consulting funding from Amgen, Pfizer, Lilly, Radius and is a speaker for Amgen and Radius. Publisher Copyright: © 2020 Elsevier B.V.
PY - 2021/4/1
Y1 - 2021/4/1
N2 - 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.
AB - 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.
KW - Bone formation
KW - Bone resorption
KW - Bone turnover markers
KW - C-terminal telopeptide of type I collagen
KW - Harmonization
KW - PINP
KW - Procollagen type I N-propeptide
KW - Standardization
KW - β-CTX
UR - http://www.scopus.com/inward/record.url?scp=85099205225&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cca.2020.12.023
DO - https://doi.org/10.1016/j.cca.2020.12.023
M3 - Article
C2 - 33382995
SN - 0009-8981
VL - 515
SP - 16
EP - 20
JO - Clinica chimica acta; international journal of clinical chemistry
JF - Clinica chimica acta; international journal of clinical chemistry
ER -