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[希森美康(®)CS-2100i全自动凝血分析仪(西门子)的评估]

[Evaluation of the automated coagulation analyzer Sysmex(®) CS-2100i (Siemens)].

作者信息

Martin-Toutain Isabelle, Jobic Lionel, Mancic Tessy, Ankri Annick

机构信息

Groupe hospitalier Pitié-Salpêtrière, service d'hématologie biologique, Paris, France.

出版信息

Ann Biol Clin (Paris). 2011 Nov-Dec;69(6):699-704. doi: 10.1684/abc.2011.0624.

Abstract

The Sysmex(®) CS-2100i is a fully automated multiparameter hemostasis analyzer equipped with a photo-optical clot detection unit, a cap-piercing system and a pre-analytical check screens for interfering substances such as bilirubin, lipids and haemolysis (HIL system). It is designed to perform coagulation tests as well as chromogenic and immunologic assays. The aim of the present study was to evaluate its performance. The tests performed were routine coagulation (prothrombin time, activated partial thromboplastin time, fibrinogen, factor VIII and factor V), chromogenic (antithrombin) and immunologic assays (D-Dimer). The intra-assay and inter-assay coefficients of variation (CV) were below 5% for most parameters both in the normal and in the pathological range (exceptions: intra-assay CV = 5.65% for the fibrinogen in the low range of concentrations; and inter-assay CV = 6% for clotting factor). The measured lower limits of linearity for factor VIII and factor V were satisfactory. No sample or reagent carryover was detected in the conditions of the study. Our results demonstrated that using the CS-2100i analyzer, routine coagulation testing can be performed with satisfactory precision.

摘要

希森美康(®)CS - 2100i是一款全自动多参数止血分析仪,配备了光电凝血检测单元、穿刺帽系统以及针对胆红素、脂质和溶血等干扰物质的分析前检查屏幕(HIL系统)。它旨在进行凝血试验以及发色底物法和免疫分析。本研究的目的是评估其性能。所进行的测试包括常规凝血(凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原、因子VIII和因子V)、发色底物法(抗凝血酶)和免疫分析(D - 二聚体)。在正常和病理范围内,大多数参数的批内和批间变异系数(CV)均低于5%(例外情况:纤维蛋白原在低浓度范围内批内CV = 5.65%;凝血因子批间CV = 6%)。因子VIII和因子V的线性测量下限令人满意。在本研究条件下未检测到样本或试剂残留。我们的结果表明,使用CS - 2100i分析仪可以以令人满意的精密度进行常规凝血检测。

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