Analytical validation requirements for biomarker assays

Analytical sensitivityThe ability of the assay to distinguish the analyte of interest from structurally similar substance
Analytical specificityThe degree of interference by compounds that may resemble but differ from the analyte to be quantified
LinearityThe ability of an assay to give concentrations that are directly proportional to the levels of the analyte following sample dilution
PrecisionThe agreement between replicate measurements
Limit of detectionThe lowest concentration of analyte significantly different from zero, also called the analytical sensitivity
AccuracyAgreement between the best estimate of a quantity and its true value
RepeatabilityDescribes measurements made under the same conditions
ReproducibilityDescribes measurements done under different conditions
RobustnessPrecision of an assay following changes in assay conditions, e.g., variation in ambient temperature, storage condition of reagents

Source: Jennings et al., 2009 [179]