Explanation : Interference studies involve adding the potential interferent to the sample and determining any bias of the test parameter relative to the control sample to which no interferent has been added. Explanation : Interference studies involve adding the potential interferent to the sample and determining any bias of the test parameter relative to the control sample to which no interferent has been added. 13.0 Measuring range of the assay: This section should include a summary of studies which define the measuring range (linear and non-linear measuring systems) including the limit of detection and describe information on how these were established. This summary should include a description of specimen type, number of samples, number of replicates, and preparation including information on matrix, analyte (measurand) levels and how levels were established. If applicable, add a description of high dose hook effect and the data supporting the mitigation (e.g. dilution) steps.