Abstract
Objectives
This study aims to evaluate the commutability of external quality assessment (EQA) materials and candidate reference materials (RMs) for plasma renin activity (PRA) assay.
Methods
Commutabilities of 16 candidate RMs were measured along with 40 clinical samples by the four different routine PRA assays, including three LC‒MS/MS assays and one chemiluminescence immunoassay. Sixteen candidate RMs included native/spiked human plasma pools (small-scale pools with <50 individuals) and current EQA materials (large-scale pools with >1,000 individuals). Difference in bias approach and linear regression with prediction interval approach were adopted to determine the commutability. Two-way variance analysis was used to estimate the effects of spiked and pool size on the commutability. Stability and homogeneity studies were performed.
Results
Precision and correlation performance of all assays was acceptable. In the difference in bias approach, the commutability results were not satisfactory (noncommutability: 14/16) and significant sample-specific effects were detected in assay pairs using different incubation buffers. For the prediction interval approach, no commutability was observed in the spiked small-scale pools; EQA materials (4/9) had more satisfactory commutability among all assays than the small-scale pools (2/7); RMs of large-scale pools tend to have better commutability no matter spiked or not.
Conclusions
Commutable RMs were obtainable but challenging. Current EQA materials with relatively good commutability, stability, and homogeneity were appropriate RMs. Large-scale pools are tending to be commutable. Spiking in small-scale pools was not suggested to prepare RMs. MPs adopting a uniform incubation buffer would be preferable for further commutability research.
Funding source: National High Level Hospital Clinical Research Funding
Award Identifier / Grant number: BJ-2023-094
Funding source: Beijing Natural Science Foundation
Award Identifier / Grant number: 7212087
Acknowledgments
We would like to thank our colleagues in Beijing Hospital for their kind help in sample collection. We sincerely thank the Zhejiang Disigns Diagnostics Technology Co., Ltd., Shanghai Biotree Biomedical Technology Co., Ltd, (Shanghai, China), and Shenzhen New Industries Biomedical Engineering Co., Ltd, (Shenzhen, China) for the sample testing and technical support.
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Research ethics: The collection of plasma was approved by the Ethics Committee of Beijing Hospital.
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Informed consent: This study was approved an exemption from informed consent.
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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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Competing interests: The authors state no conflict of interest.
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Research funding: This work was supported by the Beijing Natural Science Foundation (grant no. 7212087) and the National High Level Hospital Clinical Research Funding (grant no. BJ-2023-094).
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0698).
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