Prozone (Hook Effect)
Enter mean signal readings across a concentration series spanning well above the ULOQ (e.g. 10×, 100×, 1000×), and check for the prozone (hook) effect — FDA Bioanalytical Guidance (2018) requires demonstrating that increasing analyte concentration does not result in decreased signal at the high end of the range.
1. Concentration series
Enter each tested concentration (spanning well above the ULOQ — e.g. 10×, 100×, 1000×) with its replicate signal (OD) readings. No standard curve is needed here — this check works directly on raw signal vs. concentration.
| Concentration | Signal 1 | Signal 2 | Signal 3 |
|---|