The final study design for assessing reportable range is up to the laboratory director's discretion. Accredited laboratories and laboratories operating in exempt states should contact their appropriate agencies to confirm any additional requirements for assessing reportable range. The types of samples that can be used to assess reportable range include: high and low calibration materials, high and low control materials, or patient samples with known very high or very low results. Reportable range is applicable to multiplex assays, but does not need to be assessed for each target on a multiplex panel. For quantitative assays, reportable range can be verified by testing high and low concentrations just inside the known limits of the reportable range for selected targets (as indicated in the manufacturer's package insert). Reportable range can be validated on quantitative multiplex assays by performing a linearity study for each target.