"A range of expected measurements for a laboratory test. Findings outside the range may be abnormal or worth noting. Reference ranges may be determined or set in a number of ways: statistically, e.g., all values within two standard deviations of a mean data point; by consensus (all values thought by a panel of specialists to be acceptable or healthy); or pathologically (all values within the range are to be associated with good health; those outside the range are associated with the presence of a disease)."
Cut off value
The classical method to determine the cut off value between normal and disease group is to calculate two standard deviations of the difference between mean values of two groups under the independence assumption.
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The definition of a reference range (as a pure descriptive feature) originates in what is most prevalent in a reference group taken from the general population.
Values within the reference range are those within the normal distribution (not statistically) of the chosen physiologic attribute and are thus often described as within normal limits. The limits of this normal distribution of a reference range are called the "upper reference limit" (URL) and the "lower reference limit" (LRL). Attention: We prefer the word "reference" over the word "normal" to prevent the nontechnical senses of normal from being conflated with the statistical sense ("normal distribution").
Reference values per se are exclusively for descriptive purposes. Values outside the reference range are not necessarily pathologic, and they are not necessarily abnormal in any sense other than statistically. The reference range does not allow interpretation of single test results other than "is inside/outside of the range".
In health-related fields or in medicine, a reference range or reference interval is the range of values for a physiologic measurement in healthy persons respectively in the general population. It is a basis for comparison (a frame of reference) for a physician or other health care professional to interpret a set of test results for a particular patient. Laboratory tests are also used to detect diseases or disease risks. Thus, the cut-off value in the laboratory diagnostics is a fixed value, which allows separating sick people from healthy individuals and therefore allows an interpretation of the test result.