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Table 1 Assay performance parameters

From: Advances in rare cell isolation: an optimization and evaluation study

Parameter Optimization goal Definition Dependencies
Limit of detection (LOD) 0.24 cells/mL peripheral blood Detection of at least one cell of interest in 4.2 mL blood or 2.5e7 total cells Test sensitivity, recovery, Ltotal
Enrichment factor >500 Ratio between the cell-of-interest frequency before and after enrichment Depletion factor and recovery
Depletion factor >625 Ratio between the leukocyte amount before and after enrichment Bead amount high
Recovery 80% Measure of target cell loss Bead amount low
Initial leukocyte amount, Ltotal 2.5 × 107 Assay start with leukocyte cell count Blood volume 3–7 mL, enrichment factor, cell of interest frequency,
Residual leukocytes, Lfinal 2 × 104 to 4 × 104 cells Leftover leukocytes after depletion Depletion factor
Assay time 2 h Complete assay time including isolation and analysis RBC lysis quality and enrichment factor