Table III.
Assay Accuracy and Precision of QC Samples in Human Sera
| LLOQ | LQC | MQC | HQC | |
|---|---|---|---|---|
| Nominal concentration (ng/mL) | n/a | 500 | 1500 | 5000 |
| Mean observed concentration (ng/mL) | 101.0 | 526.8 | 1583.2 | 5482.5 |
| %Deviation | n/a | 5.3 | 5.5 | 9.7 |
| Inter-assay imprecision (%CV) | 14.8 | 5.1 | 1.6 | 5.2 |
| Intra-assay imprecision (%CV) | 22.0 | 4.2 | 2.7 | 5.4 |
| Total variation (%CV) | 26.5 | 12.9 | 6.9 | 7.5 |
| Total error (%) | n/a | 18.3 | 12.5 | 17.1 |
| n | 51 | 24 | 24 | 24 |
| Number of runs | 7 | 7 | 7 | 7 |
See Materials and Methods section for calculations of %CV, total variance, and total error
n/a not applicable