Table 2.
Accuracy and Precision in Plasma (A) or Plasma Pre-Stabilized with 0.1% HCl (B)
| A | ||||||
|---|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | WRP (%) | BRP (%) | n |
| 1.0 (LLOQ) | 1.10 | 0.12 | 10.0011.95 | 10.5010.29 | 4.296.61 | 1820 |
| 3.0 (LQC) | 2.79 | 0.26 | −7.506.84 | 6.126.06 | 7.638.43 | 2019 |
| 200 (MQC) | 194.96 | 12.26 | −2.52 | 2.97 | 6.24 | 20 |
| 400 (HQC) | 374.50 | 27.67 | −6.38 | 4.82 | 6.31 | 20 |
| 5,000 (DQC) | 4930.44 | 471.27 | −1.39 | 2.20 | 10.47 | 20 |
| B | ||||||
|---|---|---|---|---|---|---|
| Nominal (ng/mL) | GM (ng/mL) | SD (ng/mL) | DEV (%) | WRP (%) | BRP (%) | n |
| 1.0 (LLOQ) | 1.07 | 0.10 | 10.807.33 | 10.0311.53 | −6.82 | 1820 |
| 3.0 (LQC) | 2.79 | 0.25 | −6.91–7.83 | 7.707.93 | 5.406.92 | 2019 |
| 200 (MQC) | 183.14 | 11.56 | −8.43 | 5.63 | 3.21 | 20 |
| 400 (HQC) | 406.26 | 60.43 | 1.56 | 13.95 | 5.80 | 20 |
| 5,000 (DQC) | 4538.70 | 407.55 | −9.23 | 5.73 | 7.78 | 20 |
Abbreviations: GM, grand mean; SD, standard deviation; DEV (%) relative deviation from nominal value; WRP, within-run precision; n, number of replicate observations within each validation run; BRP, between-run precision (A hyphen indicates MSwit>MSbet, thus BRP cannot be calculated and it was concluded that no additional variation was observed as a result of performing the assay in different runs)