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 |
Source: Jennings et al., 2009 [179]