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Table 3 Analytical validation requirements for biomarker assays

From: Validation of biomarkers to predict response to immunotherapy in cancer: Volume I — pre-analytical and analytical validation

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