What is the significance of 'reportable range' in assay results?

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The concept being tested is what “reportable range” means for assay results. This is the concentration window over which an assay can report results with trusted accuracy and precision. Within this range, the test’s calibration and validation ensure that the reported numbers are reliable for clinical interpretation. If a result falls below the lower end, it may be below the assay’s reliable detection/quantitation, so it’s typically reported as below range or not detectable. If a result is above the upper end, the value can’t be trusted in its current form, and the sample is usually diluted and re-tested or a reflex test is performed to bring the measurement into range. Therefore, the reportable range defines the concentration range that can be accurately reported; results outside may require dilution or reflex testing.

Other options describe things unrelated to how results are interpreted or reported, such as temperature ranges or maximum volumes, which do not govern the accuracy and reporting of assay concentrations.