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Development of standards for laboratory automation

CLINICAL CHEMISTRY 2000年第5期46卷 746-750页

作者： Hawker, CD Schlank, MR ARUP Labs Inc Salt Lake City UT 84108 USA NCCLS Wayne PA 19087 USA

In clinical laboratories, the installation of total laboratory automation systems and/or modular systems has grown dramatically in the 1990s, particularly in the US, Japan, and Europe. As the number of installations and level of interest grew, several individuals and corporations active in the automation field recognized that the development of prospective standards might enable customers of such systems or equipment to purchase analyzers, automation systems or devices, and software from different vendors and retain interconnectivity of such equipment. These individuals also believed that the total market for automation systems and equipment would be significantly greater with standards than without standards, especially if customers were not forced to purchase everything from one vendor, and that there might be competitive pricing and new technology fostered via the standards. This early interest in standards development led to the initiation of a program by NCCLS in 1996 to develop prospective standards for laboratory automation. Part of the NCCLS effort has involved interaction and cooperation with other standards organizations in the US and other countries. This report describes the current status of the development of prospective standards for laboratory automation by NCCLS and the relationship of those standards to those of other standards organizations. (C) 2000 American Association for Clinical Chemistry.

关键词：自动化/仪器和设备自动化/标准血样采集/仪器和设备血样采集/标准临床实验室技术/仪器和设备临床实验室技术/标准实验室/标准人类

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Newer portable glucose meters - Analytical improvement compared with previous generation devices?

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CLINICAL CHEMISTRY 1999年第10期45卷 1821-1825页

作者： Weitgasser, R Gappmayer, B Pichler, M St Johanns Spital Gen Hosp Dept Med 2 A-5020 Salzburg Austria

Background: Newer glucose meters are easier to use, but direct comparisons with older instruments are lacking. We wished to compare analytical performances of four new and four previous generation meters. Methods: On average, 248 glucose measurements were performed With two Of each brand of meter on capillary blood samples from diabetic patients attending our outpatient clinic. Two to three different lots of strips were used. All measurements were performed by one experienced technician, using blood from the same sample for the meters and the comparison method (Beckman Analyzer 2). Results were evaluated by analysis of clinical relevance using the percentage of values within a maximum deviation of 5% from the reference value, by the method of residuals, by error grid analysis, and by the CVs for measurements in series. Results: Altogether, 1987 blood glucose values were obtained with meters compared with the reference values. By error grid analysis, the newer devices gave more accurate results without significant differences within the group (zone A, 98-98.5%). Except for the One Touch II (zone A, 98.5%), the other older devices were less exact (zone A, 87-92.5%), which was also true for all other evaluation procedures. Conclusions: New generation blood glucose meters are not only smaller and more aesthetically appealing but are more accurate compared with previous generation devices except the One Touch II. The performance of the newer meters improved but did not meet the goals of the latest American Diabetes Association recommendations in the hands of an experienced operator. (C) 1999 American Association for Clinical Chemistry.

关键词：门诊医疗血糖/分析临床实验室技术/仪器和设备糖尿病/血液参考值人类

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