Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
Clin Chem
; 56(2): 165-71, 2010 Feb.
Article
em En
| MEDLINE
| ID: mdl-20007858
ABSTRACT
As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays.
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
/
Prevencao_e_fatores_de_risco
/
Alimentacao
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Proteômica
/
Testes Diagnósticos de Rotina
Tipo de estudo:
Health_technology_assessment
/
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Clin Chem
Assunto da revista:
QUIMICA CLINICA
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos