Interlaboratory evaluation of LC-MS-based biomarker assays.
Bioanalysis
; 16(6): 389-402, 2024 Mar.
Article
em En
| MEDLINE
| ID: mdl-38334082
ABSTRACT
Validation of biomarker assays is crucial for effective drug development and clinical applications. Interlaboratory reproducibility is vital for reliable comparison and combination of data from different centers. This review summarizes interlaboratory studies of quantitative LC-MS-based biomarker assays using reference standards for calibration curves. The following points are discussed trends in reports, reference and internal standards, evaluation of analytical validation parameters, study sample analysis and normalization of biomarker assay data. Full evaluation of these parameters in interlaboratory studies is limited, necessitating further research. Some reports suggest methods to address variations in biomarker assay data among laboratories, facilitating organized studies and data combination. Method validation across laboratories is crucial for reducing interlaboratory differences and reflecting target biomarker responses.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Espectrometria de Massas em Tandem
/
Espectrometria de Massa com Cromatografia Líquida
Tipo de estudo:
Guideline
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Japão