Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges
Author:
Liu Zhenni12ORCID, Jin Lizi12ORCID, Ma Zijia12, Nizhamuding Xiaerbanu12, Zeng Jie1, Zhang Tianjiao12, Zhang Jiangtao1, Zhou Weiyan1, Zhang Chuanbao12
Affiliation:
1. National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology , Beijing , P.R. China 2. Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing , P.R. China
Abstract
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.
Funder
National High Level Hospital Clinical Research Funding Beijing Natural Science Foundation
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
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