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血气分析仪Gem PREMIER 3000的评估

Evaluation of the blood gas analyzer Gem PREMIER 3000.

作者信息

Bénéteau-Burnat Bénédicte, Bocque Marie-Chantal, Lorin Anne, Martin Catherine, Vaubourdolle Michel

机构信息

Service de Biochimie A, Hôpital Saint-Antoine, AP-HP, Paris, France.

出版信息

Clin Chem Lab Med. 2004 Jan;42(1):96-101. doi: 10.1515/CCLM.2004.018.

Abstract

During the past few decades, new technologies have allowed the fabrication of miniaturized sensors and the development of analyzers well designed for point-of-care testing (POCT). They combined the ease-of-use and portability required for POC with the accuracy and the reliability of traditional systems. Instrumentation Laboratory introduced the GEM Premier 3000, a compact and portable system to rapidly analyze pH, pCO2, PO2, Ca2+, Na2+, K+, lactate, glucose and hematocrit, from 135 microl of whole blood with a simple component: a cartridge, the GEM Premier Pak. The analytical performance was compared with the Radiometer ABL 725 instrument for blood gas/ electrolytes/metabolites, and for hematocrit with the centrifuged microhematocrit method. Aqueous quality control materials (Instrumentation Laboratory) were used for precision and recovery studies. The evaluation was performed according to the Valtec protocol, designed by the French Society of Clinical Biology, for imprecision, linearity and accuracy. With-in-run and between-run imprecisions for all the parameters gave good CV values. Linearity was good and results comparison showed close agreement with correlation coefficients between 0.91 and 0.99. The analyzer is very easy to use; the simplicity and the convenience of only one consumable make the GEM Premier 3000 very suitable for a STAT laboratory or for POCT.

摘要

在过去几十年中,新技术使得小型化传感器得以制造,并且开发出了专为即时检验(POCT)精心设计的分析仪。它们将即时检验所需的易用性和便携性与传统系统的准确性和可靠性结合在了一起。Instrumentation Laboratory公司推出了GEM Premier 3000,这是一款紧凑且便携的系统,可通过一个简单组件——GEM Premier Pak试剂盒,从135微升全血中快速分析pH值、pCO2、PO2、Ca2+、Na2+、K+、乳酸、葡萄糖和血细胞比容。将该分析仪的分析性能与用于血气/电解质/代谢物分析的Radiometer ABL 725仪器进行了比较,并采用离心微量血细胞比容法对血细胞比容进行了比较。使用水性质量控制材料(Instrumentation Laboratory公司)进行精密度和回收率研究。根据法国临床生物学协会设计的Valtec方案进行不精密度、线性和准确性评估。所有参数的批内和批间不精密度均给出了良好的CV值。线性良好,结果比较显示相关性系数在0.91至0.99之间,二者吻合度较高。该分析仪使用非常简便;仅需一种耗材的简单性和便利性使得GEM Premier 3000非常适合急诊实验室或即时检验。

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