![]() Nevertheless, it is important to fully characterise the analytical performance of every clinical laboratory test in order to understand its capability and limitations, and to ensure that it is “fit for purpose.” Moreover, defining the limits of an assay at low concentration is directly related to its dynamic range, or analytical measurement range. ![]() For example, the medical decision levels for glucose and cholesterol are so far above the lower analytical limits of these tests that it is highly unlikely that clinical action will depend on measurements of these analytes at such low concentration. ![]() Clinical laboratorians have perhaps been lax in dealing with this analytical issue because, in many cases, the ability of a laboratory test to detect a very small amount of measurand is not clinically significant. Likewise, there have been various methods for estimating it. There has often been a lack of agreement within the clinical laboratory field as to the terminology best suited to describe this parameter.
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