Table 5. Lower limit of detection* of the artus QS-RGQ assay.
| Intended concentration (IU/mL) | Replicate N | Detected N | % Detected | Probability (%) |
|---|---|---|---|---|
| 20.0 | 12 | 12 | 100.0 | 100.0 |
| 10.0 | 12 | 12 | 100.0 | 100.0 |
| 5.0 | 12 | 12 | 100.0 | 100.0 |
| 2.5 | 12 | 11 | 91.7 | 91.8 |
| 1.0 | 12 | 7 | 58.3 | 58.5 |
*The concentration with 95% probability of detection was 2.95 IU/mL according to probit analysis.