Analytical considerations and plans to standardize or harmonize assays for the reference bone turnover markers PINP and β-CTX in blood

Procollagen type I N-propeptide (PINP) and the C-terminal telopeptide of type I collagen (beta-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 beta-CTX in serum and plasma. The results of these studies will inform our work towards the harmonization of PINP assays and the standardization of beta-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 beta-CTX.

Automated summary

The International Osteoporosis Foundation and International Federation of Clinical Chemistry and Laboratory Medicine have designated PINP and beta-CTX as reference bone turnover markers. Efforts are being made to harmonize and standardize these markers, with the development of common calibrators and reference measurement procedures, in order to establish universally acceptable practice guidelines for the management of osteoporosis.