Laboratory-Related Outcomes in Healthcare (Beckman Conference) (Clinical Report‪)‬

Medical tests are central to modern medicine and require better characterization than has been the norm in the past. Tests must be characterized in several important ways (Table 1). Conceptually, the first step is to determine the analytical features of a new test. Clinical chemists have focused on (and are the traditional experts on) analytical features: precision, accuracy (or "trueness"), detection limits, linearity, interferences, and so forth. This focus is clearly evident from the "Information for Authors" of Clinical Chemistry (1), and articles in this Journal and elsewhere have exemplified the high standards of clinical chemists in defining the analytical performance of tests. Clinical chemists have also been active in other areas of test evaluation. They are among the foremost pioneers in the characterization of nonanalytical factors related to tests, including within- and between-person biological variation. In recent years, clinical chemists and clinical epidemiologists have stressed the need to improve the characterization of the diagnostic accuracies of tests (2,3). Indeed, the "Information for Authors" of Clinical Chemistry (1) now contains a checklist (3) of items to include in studies of diagnostic accuracy. By contrast, neither clinical chemists nor others have focused as intently on studies of the clinical usefulness of tests.