A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins.
J Pharm Biomed Anal
; 53(3): 729-34, 2010 Nov 02.
Article
em En
| MEDLINE
| ID: mdl-20457502
ABSTRACT
Outsourcing and multi-site testing has increased for ligand binding assays supporting protein therapeutic measurement. It is common to combine and compare data across studies with data from multiple bioanalytical sites. We designed a prospective study to determine the benefits of increasing control over the transfer process to improve ruggedness. The experiment involved the testing of 30 incurred samples at 3 stages with incremental laboratory harmonization in standard/quality controls and assay components Stage I represented a transfer of a detailed protocol and critical reagents. Stage II, a single source of standards and quality controls were provided to each site. Stage III, standards and quality controls plus a ready-to-use kit were provided. The results indicated that all testing facilities failed agreement testing using the stage I procedure. The introduction of standards from a single source improved the agreement. The modification reduced variation by 33% compared to the stage I approach. There was no additional benefit when a packaged kit was provided. In conclusion, introduction of a single source of standards and quality controls reduced the inter-site component of variation and should allow for combinability of data.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ensaio de Imunoadsorção Enzimática
/
Proteínas
Tipo de estudo:
Guideline
/
Observational_studies
Limite:
Humans
Idioma:
En
Revista:
J Pharm Biomed Anal
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos