Flow cytometry affords outstanding statistical power to detect rare cell populations and quantify cellular phenotypes in biological samples for both pre-clinical and clinical applications. However, flow cytometric methods can be extremely challenging to develop and validate, especially given the complexity of the measurements involved and the lack of standardized cellular reference materials.
What is Assay Validation?
Assay validation is performed to demonstrate that the adopted method displays the required performance characteristics over the designated range of conditions of the study. Since flow cytometry is considered an analytical method, the FDA requires that clinical flow cytometric studies meet specific analytical method validation criteria to confirm that the process is fit for its intended use:
Detection Limits
Limits of quantitation
Robustness
Precision
Specificity
Linearity
Stability requirements
Accuracy
Range
Our scientific and global quality management teams develop and validate studies with a commitment to quality, ensuring that every aspect of the method, analytics and reporting meet the regulatory requirements for intended use.
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