Abstract
Objectives
To validate urine as a suitable matrix for copeptin measurements, derive a urinary copeptin/creatinine ratio in an apparently healthy sample of the population, and assess pre-analytical conditions such as collection type and storage temperatures that affect stability and recovery.
Methods
Matrix effect was determined by spiking the manufacturer’s calibrator F simultaneously into pooled serum and aliquots of spot urine sample donated by a single volunteer. Stability was assessed without preservatives as well as 0.0032×g of thymol or 1 mL of 5 M hydrochloric acid. The urinary copeptin-to-creatinine ratio reference limit was derived from random spot urines collected from 120 apparently healthy volunteers who met the selection criteria.
Results
Our in-house derived urinary copeptin-to-creatinine ratio was<2.5 pmol/mmol creatinine, and there was a statistically significant difference in urinary copeptin concentration between males and females, but this was eliminated when corrected for urine creatinine. 24-h and spot urine with and without preservatives were stable for 7 days at 4–8 °C, 23–25 °C, and −20 °C. Limits of blank, limits of detection, and limit of quantitation were 1.1 pmol/L, and 1.81 pmol/L, respectively.
Conclusions
Urine matrix does not distort the kinetics of the BRAHMS Thermo Fisher Copeptin assay and therefore could be measured with high accuracy. The clinical utility of urinary copeptin is still unknown, however, there is growing interest in this area in patient with autosomal polycystic kidney disease.
Acknowledgments
We’d like to acknowledge A/Prof Tony Badrick from the Royal College of Pathologist of Australasia Quality Assurance Program (RCPA QAP) for his valuable input in reviewing the manuscript and providing constructive feedback.
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Research ethics: The study was approved by the Sydney Local Health District Ethics Committee at Royal Prince Alfred Hospital (X18-0127 & HREC/18/RPAH/174).
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Informed consent: Informed consent was obtained from all individuals included in this study, or their legal guardians or wards.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: ProWriting Aid used to correct grammatical errors.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
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