Abstract
The evaluation of new reagents and instruments in clinical chemistry leads to complex studies with large volumes of data, which are difficult to handle. This paper presents the design and development of a program that supports an evaluator in the definition of a study, the generation of data structures, communication with the instrument (analyser), online and offline data capture and in the processing of the results. The program is called CAEv, and it runs on a standard PC under MS-DOS. Version 1 of the program was tested in a multicentre instrument evaluation. The concept and the necessary hardware and software are discussed. In addition, requirements for instrument/host communication are given. The application of the laboratory part of CAEv is described from the user's point of view. The design of the program allows users a high degree of flexibility in defining their own standards with regard to study protocol, and/or experiments, without loss of performance. CAEv's main advantages are a pre-programmed study protocol, easy handling of large volumes of data, an immediate validation of the experimental results and the statistical evaluation of the data.