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用于分析血管性血友病因子瑞斯托霉素辅因子活性的快速自动化检测方法的评估。

Evaluation of a rapid automated assay for analysis of von Willebrand ristocetin cofactor activity.

作者信息

Strandberg Karin, Lethagen Stefan, Andersson Kerstin, Carlson Margareta, Hillarp Andreas

机构信息

Department of Coagulation Disorders, Lund University, Malmö University Hospital, Sweden.

出版信息

Clin Appl Thromb Hemost. 2006 Jan;12(1):61-7. doi: 10.1177/107602960601200110.

Abstract

A commercially available turbidometric assay has been evaluated for the measurement of von Willebrand factor ristocetin cofactor activity (VWF:RCo). The assay is simple, rapid, and can be cost-effectively performed on automated coagulation analyzers. This study's aim is to illustrate the performance of the automated VWF:RCo assay and its capacity to identify patients with von Willebrand disease (VWD). By direct comparison with a conventional VWF:RCo assay, performed on an aggregometer, the concordance between the two assays was 96%. With minor modifications, the automated assay showed a detection level of 0.03 kIU/L with linearity to 2.00 kIU/L. The imprecision of the automated assay was reduced compared to the conventional assay procedure with CV of 6.8% at the 1.00 kIU/L level and 8.6% at the 0.30 kIU/L level. The automated VWF:RCo assay was also suitable as a screening test to detect VWD in patients investigated for the cause of an increased bleeding tendency. In this situation the automated VWF:RCo assay was tested simultaneously with an automated immunoassay for von Willebrand antigen. Receiver operating curves for the diagnosis of VWD showed a greater area under the curve for the automated VWF:RCo assay compared to the immunoassay, 0.98 vs. 0.94, although the difference did not reach significance. In conclusion, the modified automated VWF:RCo assay shows better precision, lower detection limit, is faster to perform with a lower cost per test compared to the conventional aggregometer based VWF:RCo activity method and is an alternative to an antigen immunoassay as a screening test for VWD.

摘要

已对一种市售的比浊法测定血管性血友病因子瑞斯托霉素辅因子活性(VWF:RCo)进行了评估。该测定方法简单、快速,且能在自动凝血分析仪上经济高效地进行。本研究的目的是阐述自动VWF:RCo测定的性能及其识别血管性血友病(VWD)患者的能力。通过与在凝集仪上进行的传统VWF:RCo测定直接比较,两种测定方法的一致性为96%。经过微小修改后,自动测定法的检测水平为0.03 kIU/L,线性范围达2.00 kIU/L。与传统测定方法相比,自动测定法的不精密度有所降低,在1.00 kIU/L水平时变异系数为6.8%,在0.30 kIU/L水平时为8.6%。自动VWF:RCo测定也适用于对有出血倾向增加原因而接受检查的患者进行VWD筛查。在这种情况下,自动VWF:RCo测定与血管性血友病抗原的自动免疫测定同时进行检测。VWD诊断的受试者工作特征曲线显示,自动VWF:RCo测定的曲线下面积大于免疫测定,分别为0.98和0.94,尽管差异未达到显著水平。总之,与基于传统凝集仪的VWF:RCo活性方法相比,改良后的自动VWF:RCo测定具有更高的精密度、更低的检测限,检测速度更快且每次检测成本更低,并且可作为VWD筛查试验替代抗原免疫测定。

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