Measuring range of the assay: This section should ...

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.