Two‐dimensional electrophoresis in the development of clinical laboratory tests

Before any new test should be introduced into clinical laboratory practice the need for the test should be carefully assessed. Generally, new tests should only be made available when they have distinct advantages over other tests to assess the same organ function or disease process. The appropriateness of the test must be considered in relation to its intended application and it must be examined in the proper clinical context when it is advocated as a diagnostic test. The potential applications of two‐dimensional electrophoresis in the clinical laboratory have been examined. These include its actual use as a diagnostic test with serum and urine specimens, if the simultaneous examination of several proteins can be justified, and if an important role in the identification of disease related changes in protein concentrations can be established which could subsequently be exploited to develop specific diagnostic tests; then the method has a valid application in the search for new clinical procedures.