A Multicentre European Evaluation of the Kodak EKTACHEM GLU/BUN Analyzer Using NCCLS Guidelines and Other Approaches

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Abstract
This paper describes the field performance of the Kodak EKTACHEM GLU/BUN [glucose/blood urea nitrogen] Analyzer for glucose and urea. NCCLS [National Committee for clinical Laboratory standards] protocols PSEP-2, 3 and 4 were used which enable manufacturers to establish performance claims concerning the precision and accuracy of an analytical system. This multicenter trial used 4 analysers in 4 European countries, United Kingdom, France, West Germany and Italy to assess within and between laboratory performances. Freeze dried control materials were used for the performance check experiment PSEP-2 and for the replication experiment PSEP-3. The replication study, although very time consuming, was straight forward to undertake and the results were comparable between centres. Compliance with the protocol for comparison of methods experiment PSEP-4 in which laboratories used their own hospital patient samples was more difficult. The problems with obtaining suitable samples and the performance of comparative methods are discussed in detail.

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