FlowMetric’s Available Valida4on Tests • All Valida4on plans are created fit-‐for-‐purpose for each client • Valida4on plans evaluate assay reliability and overall performance and may include but are not limited to: Example of Inter-‐sample variability of Regulatory T cells in Cynomolgus macaque Singlets Live Cells Lymphocytes CD3+CD4+ Cells
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Sample stability • Processed Stability • Freeze/Thaw Stability • Long-‐Term Stability Assay specificity Inter-‐sample variability
<APC> CD25
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Cyno 1
Cyno 2
Cyno 3 <APC> CD25
• Robustness of the assay • Limits of Detec4on • Dynamic Range/Limits of Quan4fica4on • Dilu4onal Linearity
<APC> CD25
• Precision of the assay • Inter-‐assay Precision • Accuracy • Curve Suitability • Repeatability (Intra-‐assay Precision)
Number in dot plot represents percentage 1