希森美康CA 6000全自动凝血分析仪的评估

Evaluation of the automated coagulation analyzer SYSMEX CA 6000.

作者信息

Quehenberger P, Kapiotis S, Handler S, Ruzicka K, Speiser W

机构信息

Clinical Institute of Medical and Chemical Laboratory Diagnostics, University of Vienna, Austria.

出版信息

Thromb Res. 1999 Oct 1;96(1):65-71. doi: 10.1016/s0049-3848(99)00069-9.

DOI:10.1016/s0049-3848(99)00069-9

PMID:10554086

Abstract

In the present study the coagulation analyzer SYSMEX CA 6000 (TOA Medical Electronics Co., Kobe, Japan), an analyzer equipped with a photooptical clot detection unit and a cap-piercing system, was evaluated with respect to its technical characteristics in the determination of standard coagulation tests (prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, and antithrombin) and in the determination of coagulation single factor activities. In the normal and in the pathological range the intraassay coefficients of variation (CV) and interassay CV for most parameters were below 5% (exceptions: intraassay CV 5.4% for prolonged thrombin time; intraassay CV 9.26% and interassay CV 10.7% for decreased antithrombin; interassay CV 5.62% for fibrinogen in the normal range, intraassay CV 10.1% for fibrinogen greater than 7.0 g/L; intraassay CV 6.36% and interassay CV 11.7% for decreased fibrinogen; interassay CV 11.6% for prolonged activated partial thromboplastin time; interassay CV 6.12% for decreased factor VII). Interference studies with lipemic, icteric, and hemolytic samples showed just minor influences of these abnormal sample characteristics on prothrombin time, activated partial thromboplastin time, fibrinogen, and antithrombin measurements when compared to the results obtained by using mechanical clot detection (STA, Stago Diagnostica, Asnieres-Sur-Seine, France). No carryover was detected in alternating measurements of heparinized (3 U/mL unfractionated heparin) and normal plasma samples. Measurement of the activities of clotting factors V, VII, VIII, and IX showed a good correlation (r=0.993 to r=0.977) between SYSMEX CA 6000 and STA. Our results demonstrate that using SYSMEX CA 6000 analyzer basal routine coagulation testing as well as specialized tests for single factor activities can be performed with satisfactory precision; in particular, the cap-piercing system has no negative effect on the performance of the analyzer.

摘要

在本研究中，对配备光电凝血检测单元和穿刺帽系统的凝血分析仪SYSMEX CA 6000（日本神户东亚医用电子株式会社）在标准凝血试验（凝血酶原时间、活化部分凝血活酶时间、凝血酶时间、纤维蛋白原和抗凝血酶）测定以及凝血单因子活性测定方面的技术特性进行了评估。在正常范围和病理范围内，大多数参数的批内变异系数（CV）和批间CV均低于5%（例外情况：延长的凝血酶时间批内CV为5.4%；抗凝血酶降低时批内CV为9.26%，批间CV为10.7%；正常范围内纤维蛋白原批间CV为5.62%，纤维蛋白原大于7.0 g/L时批内CV为10.1%；纤维蛋白原降低时批内CV为6.36%，批间CV为11.7%；活化部分凝血活酶时间延长时批间CV为11.6%；因子Ⅶ降低时批间CV为6.12%）。与使用机械凝血检测（法国阿斯尼埃 - 塞纳河畔斯塔戈诊断公司的STA）获得的结果相比，对脂血、黄疸和溶血样本的干扰研究表明，这些异常样本特性对凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原和抗凝血酶测量的影响较小。在肝素化（3 U/mL普通肝素）和正常血浆样本的交替测量中未检测到残留。凝血因子Ⅴ、Ⅶ、Ⅷ和Ⅸ活性的测量显示，SYSMEX CA 6000与STA之间具有良好的相关性（r = 0.993至r = 0.977）。我们的结果表明，使用SYSMEX CA 6000分析仪可以以令人满意的精密度进行基础常规凝血检测以及单因子活性的专门检测；特别是，穿刺帽系统对分析仪的性能没有负面影响。