2023-10-04T04:42:51
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.
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