Table 1.
Quality control samples | ||||
---|---|---|---|---|
Parameters | LLOQ (5.00 ng/mL) | Low (15.0 ng/mL) | Medium (900 ng/mL) | High (12,000 ng/mL) |
Accuracy and Precision | ||||
Intra-assay (%RE, %CV) | 1.9~8.3, 3.3~6.2 | −4.4~4.7, 2.6~3.9 | −9.9~7.2, 1.1~2.8 | −7.6~7.6, 1.3~5.7 |
Inter-assay (%RE, %CV) | 5.8, 5.4 | 3.2, 3.2 | −8.0, 2.7 | −6.7, 2.0 |
Recovery (%) | / | 119.0 | 106.2 | 110.1 |
%CV | / | 2.0 | 2.3 | 1.4 |
Stability with accuracy | ||||
−20 °C 29 days (%RE, %CV) | / | −1.6, 4.4 | / | −8.3, 2.2 |
−70 °C 88 days (%RE, %CV) | / | 5.4, 5.5 | / | 0.6, 2.4 |
room temperature 6 hrs (%RE, %CV) | / | −3.9, 3.0 | / | −8.6, 2.0 |
3 FT (−70 °C) (%RE, %CV) | / | 6.2, 4.8 | / | −4.3, 1.9 |
Recovery of IS (%RE, %CV) | 105, 1.8 |
Abbreviations: LLOQ, lower limit of quantification; RE, relative error; CV, coefficient of variations; FT, freeze-thaw cycle; IS, internal standard.