Assay Validation Test Sheet

1
FlowMetrics Available Valida4on Tests

• All Valida4on plans are created
  ?t--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

• Precision of the assay

• Inter--assay Precision
• Accuracy
• Curve Suitability
• Repeatability (Intra--assay Precision)
• Robustness of the assay
• Limits of Detec4on
• Dynamic Range/Limits of Quan4?ca4on
• Dilu4onal Linearity

Singlets Live Cells Lymphocytes CD3CD4 Cells
Cyno 1
Cyno 2
Cyno 3

• Sample stability
• Processed Stability
• Freeze/Thaw Stability
• Long--Term Stability

ltAPCgt CD25
ltAPCgt CD25
ltAPCgt CD25

• Assay speci?city
• Inter--sample variability

Number in dot plot represents percentage 1