Evaluation of the automated coagulation analyzer Sysmex® CA-7000
Evaluation of the automated coagulation analyzer Sysmex® CA-7000
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DOI：
10.1016/j.thromres.2005.06.012
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发表时间：
2006-01-01
影响因子：
7.5
通讯作者：
Toulon, P
中科院分区：
文献类型：
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作者：
Fischer, F;Appert-Flory, A;Toulon, P
Sysmex (R) CA-7000是一款全自动多参数止血分析仪，配备光学血块检测单元和穿帽系统。它的目的是执行凝血试验以及显色和免疫分析。在一所大学医院的凝血实验室对其在常规凝血（凝血酶原时间、活化的部分凝血活酶时间、纤维蛋白原和单一凝血因子）、显色（抗凝血酶和抗fxa活性）和免疫测定（冯氏血友病因子）方面的技术特征进行了评估。在正常和病理范围内，大多数参数的测定内和测定间变异系数（CV）都低于5%（例外：纤维蛋白原和抗凝血酶在两个浓度范围内的测定内CV=5.2%，抗凝血酶在两个浓度范围内的测定内CV= 5.1%；凝血因子V和VII在正常范围内的测定间CV= 5.7%和7.2%，抗fxa活性在6.1%至7.8%的范围内）。与使用基于机械血块检测的分析仪（STAR）获得的结果相似，溶血和黄疸样品没有明显的干扰。在肝素化（1.0 IU/mL未分离肝素）和正常血浆样品交替测量中未检测到携带。CA-7000分析仪的不同凝血、显色和免疫测定结果与STAR分析仪的结果具有良好的相关性（r在0.885 ~ 0.990范围内）。我们的研究结果表明，使用CA-7000分析仪，常规凝血检测可以以令人满意的精度进行，同样适用于更专业和特定的测试，如单因素活性或抗原浓度。(c) 2005 Elsevier Ltd版权所有。
The Sysmex (R) CA-7000 is a fully automated multiparameter hemostasis analyzer equipped with a photo-optical clot detection unit and a cap-piercing system. It is designed to perform coagulation tests as well as chromogenic and immunologic assays. It was evaluated in a coagulation laboratory of a university hospital with respect to its technical characteristics in the determination of routine coagulation (prothrombin time, activated partial thromboplastin time, fibrinogen and single coagulation factors), chromogenic (antithrombin, and anti-FXa activity) and immunologic assays (von Wittebrand factor). 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=5.2% for the fibrinogen and 5.1% for antithrombin in the tow range of concentrations; and inter-assay CV = 5.7% and 7.2% for clotting factors V and VII levels in the normal ranges, and in the range from 6.1% to 7.8% for anti-FXa activity). No significant interference could be demonstrated with hemolytic and icteric samples as demonstrated by results similar to those obtained using a mechanical clot detection-based analyzer (STAR). No carryover was detected in alternating measurements of heparinized (1.0 IU/mL unfractionated heparin) and normal plasma samples. The results of the different coagulation, chromogenic and immunologic assays obtained with the CA-7000 analyzer were well correlated with those obtained on the STAR analyzer (r in the range from 0.885 to 0.990). Our results demonstrated that using the CA-7000 analyzer, routine coagulation testing can be performed with satisfactory precision and the same applied to more specialized and specific tests such as single factor activity or antigen concentration. (c) 2005 Elsevier Ltd. All rights reserved.