Flow cytometric method transfer: Recommendations for best practice.
design control
flow cytometry
method transfer
technology transfer
validation
Journal
Cytometry. Part B, Clinical cytometry
ISSN: 1552-4957
Titre abrégé: Cytometry B Clin Cytom
Pays: United States
ID NLM: 101235690
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
02
03
2020
revised:
09
10
2020
accepted:
06
11
2020
pubmed:
19
11
2020
medline:
27
1
2022
entrez:
18
11
2020
Statut:
ppublish
Résumé
As with many aspects of the validation and monitoring of flow cytometric methods, the method transfer processes and acceptance criteria described for other technologies are not fully applicable. This is due to the complexity of the highly configurable instrumentation, the complexity of cellular measurands, the lack of qualified reference materials for most assays, and limited specimen stability. There are multiple reasons for initiating a method transfer, multiple regulatory settings, and multiple context of use. All of these factors influence the specific requirements for the method transfer. This recommendation paper describes the considerations and best practices for the transfer of flow cytometric methods and provides individual case studies as examples. In addition, the manuscript emphasizes the importance of appropriately conducting a method transfer on data reliability.
Identifiants
pubmed: 33207038
doi: 10.1002/cyto.b.21971
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
52-62Informations de copyright
© 2020 International Clinical Cytometry Society.
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