The results of investigations in laboratory medicine are used for many purposes. Most are performed for monitoring individuals in acute situations and following the improvement or deterioration of chronic disease. In diagnosis, case-finding, and screening, conventional population-based reference intervals are relevant, and they are partitioned if necessary according to age, sex, or other important characteristics. In spite of the advantages of fixed decision limits, these intervals remain the mainstay of interpreting numerical results. Such tools are of very limited use, however, in evaluating serial results obtained for an individual. Within-individual biological variation is well known to be much smaller than between-individual variation for nearly all substances assayed in laboratory medicine (1). Each individual has a range of values that span only a part of the reference interval. In consequence, individuals can have important changes in results when they all lie within the reference interval. Such changes will usually be considered unremarkable by both laboratory professionals and clinicians, and thus ignored. In addition, results can change from inside to outside the interval (and vice versa) without having clinical importance. Laboratories conventionally flag results outside the reference limits, probably provoking some unnecessary follow-up activity, if only a repetition of the investigation (2). Katzmann and coworkers in the current issue of the Journal have tackled the difficult problem of establishing criteria for monitoring changes in monoclonal protein concentrations (3). For some laboratory investigations, expert groups have recommended numerical criteria for interpreting changes. For the abnormal proteins in serum and urine investigated by Katzmann and colleagues (3), the guidelines from such expert groups state that reductions in the monoclonal protein in serum of at least 25% and 50% are considered minimal and partial responses, respectively, and the corresponding responses for urine monoclonal protein require at least . . .
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Improved Monitoring of Differences in Serial Laboratory Results
Fraser, Callum G.
Follow Clinical Chemistry
, Volume 57 (12): 1635
American Association for Clinical Chemistry – Dec 1, 2011
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