Table 3.
Accuracy and precision testing for the DPS and DBS samples.
| Accuracy And Precision Testing | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Within-run accuracy and precision | Dried Plasma Samples (DPS) | Dried Blood Samples (DBS) | ||||||||
| Analytical run |
LLOQ
0.250 µg/mL |
Low QC1
0.750 µg/mL |
Medium QC2
7.5 µg/mL |
High QC3 38 µg/mL |
LLOQ
0.125 µg/mL |
Low QC1
0.375 µg/mL |
Medium QC2
3.75 µg/mL |
High QC3
19 µg/mL |
||
| I | <Cdet.>, µg/mL | 0.242 | 0.693 | 6.67 | 33.45 | 0.134 | 0.411 | 4.08 | 19.71 | |
| <bias>,% | −3.21 | −7.55 | −11.11 | −11.98 | 6.90 | 9.60 | 8.74 | 3.76 | ||
| SD,µg/mL | 0.021 | 0.051 | 0.17 | 0.42 | 0.011 | 0.021 | 0.158 | 1.85 | ||
| RSD,% | 8.64 | 7.40 | 2.62 | 1.26 | 8.41 | 5.18 | 3.87 | 9.39 | ||
| II | <Cdet.>, µg/mL | 0.248 | 0.707 | 7.11 | 33.72 | 0.127 | 0.361 | 3.77 | 19.76 | |
| <bias>,% | −0.86 | −5.76 | −5.19 | −11.26 | 1.87 | 3.76 | 0.60 | 3.98 | ||
| SD,µg/mL | 0.039 | 0.065 | 0.46 | 0.62 | 0.020 | 0.032 | 0.461 | 1.5034 | ||
| RSD,% | 15.85 | 9.25 | 6.45 | 1.85 | 15.37 | 8.82 | 12.23 | 7.61 | ||
| III | <Cdet.>, µg/mL | 0.246 | 0.779 | 7.64 | 35.14 | 0.117 | 0.391 | 4.12 | 19.92 | |
| <bias>,% | −1.62 | 3.92 | 1.85 | 0.40 | −6.67 | 4.34 | 9.82 | 4.85 | ||
| SD,µg/mL | 0.037 | 0.040 | 0.36 | 1.67 | 0.012 | 0.045 | 0.212 | 2.014 | ||
| RSD,% | 14.98 | 5.15 | 4.75 | 4.75 | 9.92 | 11.53 | 5.15 | 10.11 | ||
| Between-run accuracy and precision |
LLOQ
0.250 µg/mL |
Low QC1
0.750 µg/mL |
Medium QC2
7.5 µg/mL |
High QC3
38 µg/mL |
LLOQ
0.125 µg/mL |
Low QC1
0.375 µg/mL |
Medium QC2
3.75 µg/mL |
High QC3
19 µg/mL |
||
| <Cdet.>, µg/mL | 0.245 | 0.727 | 7.14 | 34.10 | 0.126 | 0.388 | 3.99 | 19.80 | ||
| <bias>,% | −1.90 | −3.13 | −4.81 | −10.26 | 0.70 | 3.39 | 6.39 | 4.20 | ||
| SD,µg/mL | 0.031 | 0.063 | 0.52 | 1.24 | 0.015 | 0.038 | 0.326 | 1.671 | ||
| RSD,% | 12.63 | 8.67 | 7.35 | 3.65 | 12.21 | 9.84 | 8.17 | 8.44 | ||
| n | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | ||
<Cdet.>—average determined ZNS concentration calculated by taking into account 5 replications per each concentration level for within-run accuracy and precision evaluation, i.e., 15 replications per each concentration level for between-run accuracy and precision evaluation; <bias>—average percentage bias represents the deviation of average ZNS concentration determined at certain concentration level form certain nominal concentration—((<Cdet.>-nominal concentration)/nominal concentration) × 100; SD—standard deviation calculated for ZNS concentration determined at certain concentration level; RSD—percentage coefficient of variation for ZNS concentrations determined at certain concentration levels.