Bone metabolism markers (BTM) in blood and urine are useful tools for monitoring the therapeutic effect of osteoporosis and may help improve patient adherence.
In 2011, the Joint Committee on Bone Metabolism of the International Osteoporosis Foundation (IOF) and the International Institute of Clinical Chemistry (IFCC) designated procollagen type I N-propeptide (PINP) and type I collagen C-terminal telopeptide. did. Blood (β-CTX) as a reference bone turnover marker for bone formation and bone resorption in osteoporosis, respectively. However, effective clinical implementation of these recommendations requires standardization / harmonization of commercially available assays.
A newly published review, “Analytical considerations and plans for standardizing or harmonizing the assay for reference bone turnover markers PINP and β-CTX in blood,” is a review of the assay for PINP and β-CTX in blood. Current status, and continued progress towards achieving harmonization or standardization of commercial assays for these reference markers.
In addition to reviewing the structure of PINP and β-CTX molecules, the authors provide current commercially available assays, their descriptions, and a concise reference summary of performance characteristics. Key characteristics and performance specifications of the four and three commercial β-CTX assays for serum PINP and the regression equations for the Roche and IDSiSYS automated assays for PINP and β-CTX are provided.
In their recommendations, the author found the following:
- Universal harmonization of PINP assays is a realistic goal that needs to be achieved, with international multicenter clinical trials conducted using commercially available assays, and clinical practice with uniform reference ranges and therapeutic goals. Requirements for developing guidelines.
- Harmonization of commercial assays (if not standardized) should be possible by developing a method of referencing PINP for subjects with a GFR greater than 60 mL / min / 1.73 m2 using a common calibrator. New commercial assays developed in the future need to be traceable to newly developed calibrators and reference methods.
Although there is a large bias between the two automated assays for β-CTX in blood, as opposed to PINP, the synthesis of reference standards and the standardization of β-CTX assays are possible and for IFCC / IOF. It will be a goal. Joint Committee on Bone Metabolism. “
Professor Samuel Vashikaran, Corresponding Author
Professor Etienne Cavalier, chair of the IFCC-IOF Bone Markers Committee (C-BM), added:
“IFCC-C-BM looks forward to working with commercially available reagent manufacturers to prepare commutative international standards and develop general procedures for measuring PINP and β-CTX in blood. Regulatory approval is required for one of these modified assays once harmonization or standardization is achieved as needed. “
Professor Nicholas Harvey, chair of the IOF Committee of Scientific Advisors, added:
“Along with IFCC, the International Osteoporosis Foundation looks forward to important next steps leading to a reliable reference range throughout the assay, thus increasing the ability of these measurements to inform both clinical care and research. This project demonstrates the great value of such international cooperation in setting up cutting-edge technologies to improve bone health globally. “
International Osteoporosis Foundation
Bhattoa, HP, et al. (2020) A plan to standardize or harmonize analytical considerations with assays for reference bone turnover markers PINP and β-CTX in blood. Clinica Chimika Actor. doi.org/10.1016/j.cca.2020.12.023.
The IOF and IFCC reviews describe the current state of the assay for reference bone metabolism markers.
Source link The IOF and IFCC reviews describe the current state of the assay for reference bone metabolism markers.