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The primary role ofthe clinical chemist is to ensure the provision of diagnostic laboratory services that provide optimal patient care and are as excellent as available technology and local economic factors will allow. However, an acceptable service is provided only if high standards of analytical performance are achieved and maintained. To monitor analytical performance, most laboratories use comprehensive internal and external quality control and assurance programmes. It should be realized, however, that the strategy of these schemes is to compare present performance with previous performance and not to provide data on whether the method itself is capable of fulfilling the analytical and clinical performance standards required. Thus, before a method is brought into routine service in any laboratory, even the smallest, it is necessary to objectively assess the method itself, not only in terms of its analytical characteristics and ability to fulfill clinical needs, but also its impact on the laboratory, staff and budget. To obtain the data that allow a method to be so fully defined means that a proper and full evaluation must be carried out. It is preferable to do such an evaluation before a method (whether an instrument or reagent kit set) is purchased, but methods that are already purchased, even if in use for some time, should also be subjected to the same close scrutiny ofevaluation. Once the evaluation has been made, the method is fully characterized. The data generated can then be retained in the laboratory; only then can quality control and assurance programmes be instituted and used to ensure that the well-defined and acceptable analytical performance of the method is being maintained. The total evaluation process should be a logical progression through the steps of pre-purchase or pre-service assessment, familiarization, evaluation and objective assessment of acceptability. None of these steps should be omitted before a candidate method is brought into routine service. Many evaluation protocols have been published in the literature of clinical chemistry. Most of these are well thought-

The evaluation kit for clinical chemistry: a practical guide for the evaluation of methods, instruments and reagent kits