A LABORATORIANS PERSPECTIVE ON EVALUATION AND IMPLEMENTATION OF NEW LABORATORY TESTS

New assay development should be directed toward answering fundamental clinical questions. Caveats that must be considered before initiating assay development projects are: New assays should allow the clinician to interact with and treat a patient more effectively, thereby improvi ng medical outcome; and new assays should facilitate recapture of syst em resources, enabling cost savings or reinvestment of resources. Defi ning the clinical questions and consideration of the caveats permit a means of prioritizing assay development activities. Laboratorians are faced with evaluating several types of development activities that lea d to assay implementation in routine clinical testing. Assays can be p rioritized for up-grading to newer cost-effective technologies, provid ed the changes maintain or improve analytical and clinical performance . Predicting which research assay will have future value is difficult when clinical performance is not fully validated. However, such assay development has the greatest potential for changing the delivery of he althcare by a clinician.