Table 3 Analytical validation requirements for biomarker assays
Requirement | Definition |
|---|---|
Analytical sensitivity | The ability of the assay to distinguish the analyte of interest from structurally similar substance |
Analytical specificity | The degree of interference by compounds that may resemble but differ from the analyte to be quantified |
Linearity | The ability of an assay to give concentrations that are directly proportional to the levels of the analyte following sample dilution |
Precision | The agreement between replicate measurements |
Limit of detection | The lowest concentration of analyte significantly different from zero, also called the analytical sensitivity |
Accuracy | Agreement between the best estimate of a quantity and its true value |
Repeatability | Describes measurements made under the same conditions |
Reproducibility | Describes measurements done under different conditions |
Robustness | Precision of an assay following changes in assay conditions, e.g., variation in ambient temperature, storage condition of reagents |