Glossary Term

Repeatability and Reproducibility

Performance MetricsEN

Definition

Complementary precision measures: repeatability is variation under the same conditions (same operator, equipment, short interval); reproducibility is variation across conditions — different days, operators, lots, or laboratories.

Extended Notes

Assay verification should cover both: within-run precision across a replicate panel, and between-run variation including lot changes. Precision is concentration-dependent, so studies should include concentrations near clinical decision points, not only mid-range samples.