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Table 6 Recommended analytical criteria for biomarker development

From: Clinical proteomics for prostate cancer: understanding prostate cancer pathology and protein biomarkers for improved disease management

Validation factor Definition [277]
Accuracy Level of agreement between biomarker and standard measure of disease presence/outcome
Bias Repeated biomarker measurements do not result in under/overestimation of disease activity
Repeatability Precision of biomarker under standard "unchanged" conditions e.g. between batches
Intermediate precision Precision of biomarker test in spite of laboratory variations e.g. time analysed, operator, equipment, calibration
Reproducibility Precision of biomarker test between laboratories with potential variability in operators and measuring systems
LoD The smallest amount of analyte that can be detected with a specified probability
LoQ The smallest amount of analyte that can be quantitatively determined with acceptable precision
Linearity Measured quantity values are directly proportional to the amount of biomarker in the experimental matrix
  1. Table adapted from Yee et al. [277]