Table 1.
Calibration Linearity in Plasma (A) or Plasma Pre-Stabilized with 0.1% HCl (B)
| A | |||||
|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | CV (%) | n |
| 1 | 1.00 | 0.06 | −0.09 | 5.97 | 8 |
| 5 | 4.88 | 0.23 | −2.40 | 4.71 | 8 |
| 10 | 10.18 | 0.40 | 1.76 | 3.96 | 8 |
| 50 | 50.57 | 1.99 | 1.14 | 3.94 | 8 |
| 100 | 102.90 | 3.69 | 2.90 | 3.58 | 8 |
| 250 | 249.33 | 12.61 | −0.27 | 5.06 | 8 |
| 500 | 479.79 | 34.27 | −4.04 | 7.14 | 8 |
| B | |||||
|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | CV (%) | n |
| 1 | 0.99 | 0.07 | −0.63 | 7.28 | 8 |
| 5 | 5.01 | 0.64 | 0.23 | 12.74 | 8 |
| 10 | 10.40 | 1.35 | 4.04 | 12.98 | 8 |
| 50 | 50.27 | 3.66 | 0.55 | 7.27 | 8 |
| 100 | 99.64 | 7.42 | −0.36 | 7.45 | 8 |
| 250 | 249.02 | 23.76 | −0.39 | 9.54 | 8 |
| 500 | 481.33 | 37.44 | −3.73 | 7.78 | 8 |
Abbreviations: GM, grand mean; SD, standard deviation; DEV (%), relative deviation from nominal value; CV (%), coefficient of variation; n, number of replicate observations within each validation run, i.e. two samples at each concentration were run on four separate occasions, for a total (n) of eight samples at each concentration.