Comparison of two automated assays of BTM (CTX and P1NP) and reference intervals in a Danish population

Autor: L. Lylloff, Line Tang Møllehave, Niklas Rye Jørgensen, N. Quardon, Y. B. L. Hansen, Allan Linneberg
Jazyk: angličtina
Rok vydání: 2017
Předmět:
0301 basic medicine
Male
Vitamin D/analogs & derivatives
Procollagen/blood
Pathology
Aging
Peptides/blood
Danish population
Endocrinology
Diabetes and Metabolism
Blood Chemical Analysis/methods
Bone remodeling
Body Mass Index
0302 clinical medicine
Blood Specimen Collection/methods
Reference Values
Glomerular Filtration Rate/physiology
Vitamin D
Blood Specimen Collection
Sex Characteristics
Middle Aged
Bone Remodeling/physiology
Cohort
BTM
Female
Bone Remodeling
Procollagen
Glomerular Filtration Rate
Adult
medicine.medical_specialty
Collagen Type I/blood
030209 endocrinology & metabolism
Aging/blood
Bone resorption
Mean difference
Collagen Type I
03 medical and health sciences
Young Adult
Internal medicine
Osteoporosis treatment
medicine
Humans
Bone formation
P1NP
Life Style
Aged
business.industry
Reference intervals
Reproducibility of Results
Peptide Fragments
030104 developmental biology
CTX
business
Peptides
Peptide Fragments/blood
Biomarkers
Blood Chemical Analysis
Biomarkers/blood
Zdroj: Jørgensen, N R, Møllehave, L T, Hansen, Y B L, Quardon, N, Lylloff, L & Linneberg, A 2017, ' Comparison of two automated assays of BTM (CTX and P1NP) and reference intervals in a Danish population ', Osteoporosis International, vol. 28, no. 7, pp. 2103–2113 . https://doi.org/10.1007/s00198-017-4026-z
DOI: 10.1007/s00198-017-4026-z
Popis: Summary: Bone turnover markers are used for monitoring osteoporosis treatment. Therefore, we evaluated the agreement between different assays for CTX and PINP and established reference intervals in a cohort of 2300 individuals. We found poor agreement between assays and different reference intervals. This highlights the importance of harmonization of the assays. Introduction: Two reference markers for bone turnover have been proposed: CTX bone resorption and P1NP for bone formation. The purpose of the current study was to establish reference intervals for the two markers in a Danish cohort and to determine the agreement on the two platforms. Methods: Fasting sera from 2308 individuals (1250 males and 1058 females, age range 24–76 years) participating in the Health2006 study were analyzed for CTX and P1NP using the automated IDS-iSYS analyzer and the automated Cobas e411 analyzer. Participants in anti-osteoporotic treatment were excluded, while subjects on hormonal contraceptives were included. Results: There was significant disagreement between both the two P1NP assays with a mean difference of −3 μg/L (LoA −19 to 14) (p < 0.001) and the two CTX assays with a mean difference of 13 ng/L (LoA−187 to 214) (p < 0.001). For CTX, there was a systematic bias: at low values, Cobas measured a higher value than iSYS and at higher concentrations, iSYS measured increasingly higher values than Cobas. Based on the results, we propose three reference intervals for each sex: 25–29, 30–39, and 40–80 years for men, and 25–29, >30 (pre-menopausal), and >30 years (post-menopausal) for women. Conclusions: There is significant disagreement between the IDS-iSYS and Roche Cobas assays for both reference markers. Consequently, the reference intervals for an adult, healthy population are different depending on the analysis method used. Therefore, repeated measurements of patient samples used for monitoring of treatment should be done on the same assay. Moreover, assay-specific reference intervals should be used. Harmonization of assays for BTM is highly warranted.
Databáze: OpenAIRE
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