Accuracy & Precision (LBA)

Fit your standard curve, enter QC replicate data across runs at LLOQ/Low/Mid/High/ULOQ, and get FDA Bioanalytical Guidance (2018) Table 1 accuracy, precision, Total Error, and run-acceptance verdicts for ligand-binding assays.

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.

Weighting

2. QC data

Enter each level’s nominal concentration, then paste OD replicates per run (rows = runs, columns = replicates). FDA Table 1 A&P validation wants ≥6 independent runs and ≥3 replicates per level per run — fewer is allowed here for testing, but the report will flag it.

3. Accuracy & precision results

By QC level

Level	Nominal	n	Grand mean	% Recovery	Intra-run CV%	Inter-run CV%	Total Error%	Accuracy limit	CV limit	TE limit	Pass

Run acceptance

This 67%/50% rule is FDA’s in-study sample-analysis acceptance criterion (Table 1, In-Study Analysis Recommendations), not a formal pass/fail requirement on the six A&P validation runs themselves. It’s shown here per validation run as a reference cross-check alongside the accuracy/precision/Total Error verdicts above.