Comparison of results from commercial assays for plasma CTX: The need for harmonization

Clinical Biochemistry
Sa Paul ChubbSamuel D Vasikaran

Abstract

Plasma C-terminal telopeptide of type I collagen (CTX) is the nominated reference bone resorption marker. We set out to test the agreement of patients' results between the available plasma CTX assays. Samples were collected from patients attending tertiary hospitals and clinics for investigation and management of metabolic bone disease. Plasma (EDTA) samples were collected from fasted patients between 7.00 am and 11.00 am, divided into three portions and stored at -20°C until analysis. Plasma CTX was measured by enzyme-linked immunosorbent assay (ELISA) (Immunodiagnostic Systems plc), E170 (Roche Diagnostics) and IDS-iSYS (Immunodiagnostic Systems plc) methods. Agreement of patient sample results was assessed by Passing and Bablok regression. Commutability of the calibrators in each kit was assessed by assaying each calibrator in the alternate methods and comparing the observed results with those expected based on the relevant patients' samples method comparison; ±8.1% was set as the criterion for commutablity. 161 specimens were analysed. Regression parameters (slope, intercept) were 0.788, 0.2 ng/L for Roche vs ELISA, 1.266 and -109 ng/L for iSYS vs ELISA and 1.605 and -109 ng/L for iSYS vs Roche. Only the ELISA calibrator as...Continue Reading

References

Jan 6, 2006·Current Medical Research and Opinion·Richard EastellJean-Yves Reginster
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Dec 25, 2010·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·S VasikaranUNKNOWN IOF-IFCC Bone Marker Standards Working Group
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Mar 5, 2014·Calcified Tissue International·Helena JohanssonUNKNOWN IFCC-IOF Joint Working Group on Standardisation of Biochemical Markers of Bone Turnover

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Citations

Jul 5, 2016·Clinica Chimica Acta; International Journal of Clinical Chemistry·H A MorrisUNKNOWN IFCC-IOF Working Group for Standardisation of Bone Marker Assays (WG-BMA)
Jul 20, 2019·European Journal of Sport Science·W EvansM Ditroilo
Apr 30, 2017·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·N R JørgensenA Linneberg
Jan 27, 2019·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·G L ChristensenN R Jørgensen
Jan 1, 2021·Clinica Chimica Acta; International Journal of Clinical Chemistry·Harjit P BhattoaUNKNOWN IFCC-IOF Committee for Bone Metabolism

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