Using Sigma metrics to establish analytical product performance requirements and optimize analytical performance of an in vitro diagnostic assay using a theoretical total PSA assay as an example

INTRODUCTION: Establishing analytical performance requirements for in vitro diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize analytical performance by choosing amongst many combinations of different product performance characteristics. Sigma metrics and method decision...

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Detalles Bibliográficos
Autores principales: Petrides, Victoria, Schneider, Sharon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Croatian Society of Medical Biochemistry and Laboratory Medicine 2018
Materias:
Short Communications
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039165/
https://www.ncbi.nlm.nih.gov/pubmed/30022889
http://dx.doi.org/10.11613/BM.2018.020903

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039165/
https://www.ncbi.nlm.nih.gov/pubmed/30022889
http://dx.doi.org/10.11613/BM.2018.020903

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