IOF-IFCC international survey of global laboratory practices for bone status indices
Etienne Cavalier, Georgia Kapoula, Harjit P. Bhattoa, Giovanni Lombardi, Konstantinos Makris, Niklas Rye Jørgensen, Michael S. Reid, Aylin Sepici Dincel, Richard Pikner, Samuel D. VasikaranAbstract
Objectives
Bone status indices (BSIs) are increasingly used in metabolic bone disease, yet global laboratory practices remain poorly characterized. Building on recent IOF-IFCC nomenclature and ESCEO-IOF-IFCC recommendations, we conducted an international descriptive survey of BSI practices.
Methods
A cross-sectional web-based questionnaire was distributed to laboratory professionals through IFCC and IOF networks, email invitations, and professional networks. It covered assay availability, specimen type, analytical platforms, external quality assessment (EQA), reference intervals or clinical decision thresholds, reporting units, interpretation, and reimbursement. Data were analyzed descriptively after duplicate screening, consistency review, and unit standardization.
Results
We received 231 responses, including 225 with geographic information from 41 countries across six continents. Marked heterogeneity was observed in analytical platforms, specimen types, reporting units, reference intervals or decision thresholds, EQA participation, and reimbursement. Reference intervals varied considerably, even among laboratories using the same manufacturer and instrument. EQA participation was high for total alkaline phosphatase (ALP) and parathyroid hormone (PTH), but lower for β-isomerized C-terminal telopeptide of type I collagen (β-CTX-I) and procollagen type I N-propeptide (PINP). Adoption of β-CTX-I and PINP was incomplete, although higher among laboratories following osteoporosis patients. Access to bone-specific ALP and tartrate-resistant acid phosphatase 5b remained limited. PTH testing was poorly harmonized because second- and third-generation assays were used in parallel. Vitamin D decision thresholds varied widely, and misordering of 1,25(OH) 2 D instead of 25(OH)D was frequently perceived.
Conclusions
Global BSI laboratory practice remains highly heterogeneous. Harmonized units, intervals or decision thresholds, interpretative practices, EQA participation, assay access, and clinician education are needed.