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FP - 900分析系统的多中心评估

A multi-centre evaluation of the FP-900 analyzing system.

作者信息

Saris N E, Kansanen M, Hekali R, Huurrekorpi L, Kivistö H, Lahikainen T

出版信息

J Clin Chem Clin Biochem. 1983 Nov;21(11):683-93. doi: 10.1515/cclm.1983.21.11.683.

Abstract

The performance of the FP-900 Analyzing system manufactured by Labsystems Oy, Helsinki, Finland, was evaluated in a multi-centre study according to the principle outlined in the 1st Draft of the Standard for Instrument Testing produced by the European Committee for Clinical Laboratory Standards (ECCLS). The FP-900 System comprises a photometer for simultaneous measurement of the absorbance in a nine-compartment cuvette block, and the accessories for handling samples (sampler, simultaneous dispensing of 9 reagent charges, incubator with thermostat and shaker, and centrifuge); the photometer function, printout of results and data processing are programmable with a microprocessor. The performance specifications given by the manufacturer were checked when appropriate. As examples of typical methodologies cholesterol was selected as an end-point absorbance method, creatinine as a fixed-time (two-point) kinetic and aspartate aminotransferase as multi-point, continuous method. The within- and between-laboratory imprecision, deviation from assigned values of commercial control sera, and carry-over were determined. The performance was compared with other analytical systems: Mark I Autoanalyzer and Hitachi 705. The cost, speed and capacity was estimated from the results of the present study. The performance of the analyser and results of applying the ECCLS Draft to actual instrument testing are discussed.

摘要

根据欧洲临床实验室标准委员会(ECCLS)制定的仪器测试标准初稿中概述的原则,在一项多中心研究中对芬兰赫尔辛基的Labsystems Oy公司生产的FP - 900分析系统的性能进行了评估。FP - 900系统包括一台用于同时测量九格比色皿模块中吸光度的光度计,以及用于处理样品的附件(采样器、同时分配9种试剂、带恒温器和振荡器的孵育器以及离心机);光度计功能、结果打印输出和数据处理可通过微处理器进行编程。在适当的时候检查了制造商给出的性能规格。作为典型方法的示例,选择胆固醇作为终点吸光度法,肌酐作为固定时间(两点)动力学法,天冬氨酸转氨酶作为多点连续法。测定了实验室内和实验室间的不精密度、与商业对照血清指定值的偏差以及携带污染。将该系统的性能与其他分析系统进行了比较:Mark I自动分析仪和日立705。根据本研究结果估算了成本、速度和容量。讨论了分析仪的性能以及将ECCLS草案应用于实际仪器测试的结果。

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