2013
DOI: 10.1002/cyto.b.21108
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Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part V – assay performance criteria

Abstract: (Table 1). Definitive quantitative assays include calibrators fit to a regression model to calculate absolute values and reference standards that are well characterized and fully representative of the endogenous measurand. Definitive quantitative assays can be both accurate and precise. Relative quantitative assays utilize responseconcentration calibration, however in this scenario the reference standards are not fully characterized or truly representative of the endogenous measurand. As such, imprecision can … Show more

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Cited by 165 publications
(243 citation statements)
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“…Specific antibodies must be used in fully validated combinations since the information they provide when measured simultaneously in such combinations is clearly superior than when they are used in other less informative antibody combinations, even when only the fluorochrome positions are modified (1,2). Panel design is a key but difficult process and results of a given antibody-fluorochrome reagent combination must be objectively validated in sequential and numerous rounds of testing using approaches such as those previously described (1,(3)(4)(5)(6). Also, distinct sample preparation protocols may impact differently on the performance of combinations of different antibodies and fluorochrome conjugates (4,7,8).…”
mentioning
confidence: 99%
See 1 more Smart Citation
“…Specific antibodies must be used in fully validated combinations since the information they provide when measured simultaneously in such combinations is clearly superior than when they are used in other less informative antibody combinations, even when only the fluorochrome positions are modified (1,2). Panel design is a key but difficult process and results of a given antibody-fluorochrome reagent combination must be objectively validated in sequential and numerous rounds of testing using approaches such as those previously described (1,(3)(4)(5)(6). Also, distinct sample preparation protocols may impact differently on the performance of combinations of different antibodies and fluorochrome conjugates (4,7,8).…”
mentioning
confidence: 99%
“…Panel design is a key but difficult process and results of a given antibody-fluorochrome reagent combination must be objectively validated in sequential and numerous rounds of testing using approaches such as those previously described (1,(3)(4)(5)(6). Also, distinct sample preparation protocols may impact differently on the performance of combinations of different antibodies and fluorochrome conjugates (4,7,8). Consequently, the panels should be evaluated with the predicated sample preparation technique they will be used with.…”
mentioning
confidence: 99%
“…Formal well-defined guidance for the validation of flow cytometric assays is not currently available; however, various advisory documents can serve as practical guidelines (16)(17)(18)22).…”
Section: Discussionmentioning
confidence: 99%
“…Validation parameters were evaluated using fit-forpurpose acceptance criteria (15)(16)(17)(18). Twenty-four reportable results were evaluated in total and are depicted in Table 2; frequency (%), MFI, and MESF values were obtained for CD451CD161 neutrophils and CD451 CD141 monocytes.…”
Section: Figmentioning
confidence: 99%
“…Similar to all methods utilized in drug development, validation plans for RO must consider the intended use of the data and follow a fit-for-purpose approach specific to flow cytometric methods (37)(38)(39). By utilizing an iterative approach, the validation activities can build upon one another in order to provide comprehensive evidence of the integrity of the data as the assay follows the compound throughout the drug development lifecycle.…”
Section: Ro Assay Validationmentioning
confidence: 99%