Table 1.
20-day assay precision evaluation summary.
| Lot | N | Mean DPP-4 concentration (ng/mL) | %CV (SD) |
|||
|---|---|---|---|---|---|---|
| Within run | Between run | Between day | Totala | |||
| Low concentration control (Target: 125 ng/mL) | ||||||
| 1 | 240 | 121.7 | 3.7 (4.5) | 0 (0) | 1.7 (2.0) | 4.1 (4.9) |
| 2 | 240 | 119.6 | 4.2 (5.1) | 1.1 (1.3) | 1.9 (2.2) | 4.8 (5.7) |
| 3 | 240 | 120.0 | 3.5 (4.1) | 1.6 (2.0) | 1.8 (2.1) | 4.2 (5.1) |
| High concentration control (Target: 500 ng/mL) | ||||||
| 1 | 240 | 477.5 | 3.3 (15.9) | 1.5 (7.1) | 1.6 (7.6) | 4.0 (19.0) |
| 2 | 240 | 488.7 | 3.5 (16.9) | 0 (0) | 1.4 (7.0) | 3.7 (18.3) |
| 3 | 240 | 489.1 | 3.5 (17.0) | 0.9 (4.3) | 1.8 (8.9) | 4.0 (19.7) |
| Human serum panel | ||||||
| 1 | 240 | 285.1 | 3.5 (9.9) | 1.2 (3.4) | 1.6 (4.7) | 4.0 (11.5) |
| 2 | 240 | 296.7 | 3.4 (10.1) | 1.4 (4.1) | 1.2 (3.7) | 3.9 (11.5) |
| 3 | 240 | 289.8 | 3.3 (9.6) | 1.0 (3.0) | 1.7 (4.8) | 3.9 (11.2) |
CV: coefficient of variation; DPP-4: dipeptidyl peptidase-4; SD: standard deviation.
a
Total %CV (SD) contains within run, between run and between day variance components.