A Scheme for the Evaluation of Diagnostic Kits

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Abstract
Recent years have seen a big increase in the number and variety of diagnostic kits available commercially to the clinical laboratory. The increasing number of tests that are infrequently required makes these kits attractive to laboratories of all sizes who are able, thereby, to offer a wide range of determinations to the clinician with a minimum of effort. A further advantage of the kit is that if a number of laboratories use the same product, their results are likely to be more nearly in agreement than might otherwise be the case. However, the very fact that kits are most useful for the less common tests, and also in the emergency situation, means that the quality of the laboratory''s service is very dependent upon the quality and consistency of the kit itself. Although analysts do frequently carry out evaluations of the kits they intend to use, these evaluations are done in their own individual way so that it becomes very difficult to compare results on different products evaluated by different analysts. A standard procedure is suggested, which will result in evaluation reports that would enable comparisons to be made.

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