LLOQ (Lower Limit of Quantitation)
Fit your standard curve, enter replicate data at the proposed LLOQ concentration across runs, and get FDA Bioanalytical Guidance (2018) Table 1 sensitivity verdicts for ligand-binding assays — every replicate must pass ±25% of nominal, ±25% CV, and ≤40% Total Error for the LLOQ to be confirmed.
1. Standard curve
Paste calibrator concentration + OD pairs, one per line (tab/comma/space separated). Extra columns are treated as OD replicates and averaged for the fit, e.g. 1.25, 0.44, 0.43, 0.46. The concentration column doubles as each calibrator’s nominal value for the back-calculation check below.
2. LLOQ data
Enter the proposed LLOQ’s nominal concentration, then paste OD replicates per run (rows = runs, columns = replicates). FDA Table 1 sensitivity validation wants ≥6 independent runs and ≥3 replicates per run — fewer is allowed here for testing, but the report will flag it.
| Run | Rep 1 | Rep 2 | Rep 3 |
|---|
Blank signal (optional)
Paste blank/zero-calibrator OD replicates (comma/tab/space separated) to check FDA Table 1’s requirement that the LLOQ response be ≥5× the mean blank response. Leave empty to skip this check.