High-sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events.
Cytometry B Clin Cytom
; 100(1): 42-51, 2021 01.
Article
em En
| MEDLINE
| ID: mdl-32940947
ABSTRACT
The current consensus recommendation papers dealing with the unique requirements for the analytical validation of assays performed by flow cytometry address the validation of sensitivity (both analytical and functional) only in general terms. In this paper, a detailed approach for designing and validating the sensitivity of rare event methods is described. The impact of panel design and optimization on the lower limit of quantification (LLOQ) and suggestions for reporting data near, or below, the LLOQ are addressed. This paper serves to provide best practices for the development, optimization, and analytical validation of flow cytometric assays designed to assess rare events. Note that this paper does not discuss clinical sensitivity validation, which addresses the positive and negative predictive value of the test result.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Citometria de Fluxo
Tipo de estudo:
Diagnostic_studies
/
Guideline
Limite:
Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article