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首页> 外文期刊>Clinical chemistry and laboratory medicine: CCLM >Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation.
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Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation.

机译：根据质量规格对贝克曼库尔特AU680自动化分析系统的分析性能进行评估，以评估源自生物学变异的允许性能。

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摘要

The Beckman Coulter AU68O (Beckman Coulter, Cassina De' Pecchi, Italy) is a new analytical system, consolidating assays of various analytes. This random-access, fully automated, analyzer offers an on-board capacity of 60 photometric and three ion-selective electrode (ISE) different tests in parallel; its throughput is 800 photometric tests/hour and up to 1200 tests/hour with the ISE module. The AU680 system represents an upgrade of the AU640 system (Olympus Italia, Segrate, Italy), differing mainly by its (i) capacity to use reduced reagent and sample volumes, (ii) possibility to perform analytical methods requiring up to three reagents and (iii) priority lane performing re-runs quickly. This study was aimed to evaluate the AU680 system for precision and correlation in comparison with the AU640 for some routine assays. Furthermore, the IFCC-traceable claimed 3-part-re-agent methods for alanine aminotransferase (ALT) and aspar-tate aminotransferase (AST), dealing a solution of pyridoxal-5'-phosphate (P5P) as a separate reagent directly in the reaction cuvette, were compared to the relevant 2-part-reagent IFCC methods. On the whole, 29 analytical methods for 21 assays were evaluated, including zero and first order rate reaction, end point, immunoturbidimetry and ISE methods. Adequacy of analytical performance to clinical employment was assessed with reference to quality specifications derived from biological variation (1-3).
机译：Beckman Coulter AU68O（Beckman Coulter，意大利卡西纳德佩奇）是一种新的分析系统，用于合并各种分析物的分析方法。这款随机存取的全自动分析仪可并行提供60个光度测量和三个不同离子选择电极（ISE）测试功能。它的吞吐量是每小时800个光度测试，而使用ISE模块则可以达到每小时1200个测试。 AU680系统是AU640系统的升级版（奥林巴斯意大利，Segrate，意大利），主要区别在于（i）使用减少试剂和样品量的能力，（ii）执行最多需要三种试剂的分析方法的可能性，以及（ iii）优先车道迅速重新运行。这项研究旨在评估AU680系统的精度和相关性，与一些常规测定的AU640系统相比。此外，IFCC可追溯的要求保护的用于丙氨酸转氨酶（ALT）和天冬氨酸转氨酶（AST）的三部分试剂方法，将吡ido醛5'-磷酸（P5P）的溶液直接作为单独的试剂处理。将反应比色杯与相关的两部分试剂IFCC方法进行比较。总体上，评估了21种测定的29种分析方法，包括零和一级反应，终点，免疫比浊法和ISE方法。参照源自生物学变异的质量指标评估了临床工作的分析性能是否适当（1-3）。

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