Recommendations for quality assurance in multiparametric flow cytometry: first consensus of the Brazilian Group of Flow Cytometry (GBCFLUX)

Correia, Rodolfo Patussi; Bortolucci, Ana Carolina Apelle; Lopes, Annelise Correa Wengerkievicz; Sandes, Alex Freire; Azambuja, Ana Paula de; Viana, Marta A.; Sales, Marcelo Augusto Oliveira de; Yamamoto, Masahiro; Bacal, Nydia Strachman

doi:10.5935/1676-2444.20150061

Cited by 5 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In contrast, manpower, material, machine, and method require serious consideration in the field of FCM for which consensual resolution is needed. Various national activities have been published to support laboratories in the validation process, for instance in Brazil ( 16 ) or Germany ( 17 , 18 ).…”

Section: Legal and Regulatory Obligationsmentioning

confidence: 99%

“…A simple tool is the control of the quality of the sample in FSC/SSC plots and each single labeling vs. SSC that gives information on the quality and specificity of the immunostaining (85)(86)(87)(88). 16. As accreditation is a continuous process, we propose method validation should be repeated periodically.…”

Section: Our Proposal For the Introduction Of Laboratory Developed Tementioning

confidence: 99%

See 1 more Smart Citation

Flow Cytometric Analyses of Lymphocyte Markers in Immune Oncology: A Comprehensive Guidance for Validation Practice According to Laws and Standards

et al. 2020

View full text Add to dashboard Cite

Many anticancer therapies such as antibody-based therapies, cellular therapeutics (e.g., genetically modified cells, regulators of cytokine signaling, and signal transduction), and other biologically tailored interventions strongly influence the immune system and require tools for research, diagnosis, and monitoring. In flow cytometry, in vitro diagnostic (IVD) test kits that have been compiled and validated by the manufacturer are not available for all requirements. Laboratories are therefore usually dependent on modifying commercially available assays or, most often, developing them to meet clinical needs. However, both variants must then undergo full validation to fulfill the IVD regulatory requirements. Flow cytometric immunophenotyping is a multiparametric analysis of parameters, some of which have to be repeatedly adjusted; that must be considered when developing specific antibody panels. Careful adjustments of general rules are required to meet legal and regulatory requirements in the analysis of these assays. Here, we describe the relevant regulatory framework for flow cytometry-based assays and describe methods for the introduction of new antibody combinations into routine work including development of performance specifications, validation, and statistical methodology for design and analysis of the experiments. The aim is to increase reliability, efficiency, and auditability after the introduction of in-house-developed flow cytometry assays.

show abstract

Section: Legal and Regulatory Obligationsmentioning

confidence: 99%