14.0 Definition of Assay Cut-off: This section should provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, including: (a) the population(s) studied (demographics/selection/inclusion and exclusion criteria / number of individuals included); (b) method or mode of characterization of specimens; and (c) statistical methods e.g. Receiver Operator Characteristic (ROC) to generate results and if applicable, define gray-zone/equivocal zone. 15.0 Stability (excluding specimen stability): This section should describe claimed shelf life, in use stability and shipping studies.