Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges.
Clin Chem Lab Med
; 62(1): 67-76, 2024 01 26.
Article
em En
| MEDLINE
| ID: mdl-37470745
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 LCâMS/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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Renina
/
Espectrometria de Massas em Tandem
Limite:
Humans
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article