Martin-Toutain Isabelle, Jobic Lionel, Mancic Tessy, Brissard Alexandre, Ankri Annick
UF d'hémostase, Service d'hématologie biologique, Hôpital de la Pitié-Salpêtrière-CFX, Paris, France.
Ann Biol Clin (Paris). 2015 Jul-Aug;73(4):413-9. doi: 10.1684/abc.2015.1054.
The Sysmex® CS-5100 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 coagulometric, chromogenic and immunologic assays. The aim of the present study was to evaluate its performance. The intra-assay and inter-assay coefficients of variation (CV) were below 6% for most parameters both in the normal and in the pathological range (exceptions: intra-assay for severe factor VIII deficiency (CV = 7.4%) and for vWFRco (CV = 7.3% and 7.7%); and inter-assay for anti-Xa activity (CV = 8.8%) and vWFRco (9.3% and 11.1%). 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 Sysmex® CS-5100 analyzer, routine coagulation testing can be performed with satisfactory precision. This automate has the advantage of being connectable to an automation chain.
希森美康®CS - 5100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、帽穿刺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凝固法、发色底物法和免疫测定。本研究的目的是评估其性能。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6%(例外情况:严重因子VIII缺乏时的批内变异系数(CV = 7.4%)以及vWFRco的批内变异系数(CV = 7.3%和7.7%);抗Xa活性的批间变异系数(CV = 8.8%)以及vWFRco的批间变异系数(9.3%和11.1%))。因子VIII和因子V的测量线性下限令人满意。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,使用希森美康®CS - 5100分析仪可以以令人满意的精密度进行常规凝血检测。这款自动化仪器具有可连接到自动化流水线的优势。