The test design No amount of quality control, supervision, or resources will compensate for bad test design. The critical activities that are needed for a good test design must establish a clear understanding of what laboratory personnel and the client can expect from the test. The selection of an appro-priate test method must be based on this and on the factors listed below. Once the method has been selected, it must be set up at the laboratory. Optimisation establishes performance standards for the test process and for use in monitoring the correct performance of the test.
Optimisation is a series of experiments and their subsequent data analysis.
The purpose of the analysis is to ensure that a method is brought under statistical control, and that it is performing optimally. Validation further evaluates the test for its fitness for a given use. Depending on logistical and risk factors, validation may involve any number of activities and amount of data, with subsequent data analysis using appropriate statistics. No matter how well designed, a test must be well controlled to produce reliable results. There must be procedures, including security procedures, for protecting the integrity of results and data, including access, entry, storage, transmission, processing, and retrieval.