It is important to understand the difference between reportable range, analytical measurement range (AMR), and linearity.
AMR is the range where results are proportional to the true concentration of the analyte in the sample. It is also the range over which the test can be performed without any modifications which are not a part of the analytical process, such as sample dilution. AMR is the same as 'reportable range' in CLIA terminology. Reportable range is defined as the span of test result values over which the accuracy can be verified or test system response can be established.
Linearity is the method employed to determine the AMR. Linearity does not appear in CLIA terminology.
