Lai Shiue-Wei, Chang Chia-Yau, Cheng Shin-Nan, Hu Shu-Hsia, Lai Chung-Yu, Chen Yeu-Chin
Hemophilia Care and Research Center, Tri-Service General Hospital, Taipei, Taiwan.
Division of Hematology/Oncology, Department of Internal Medicine, Tri-service General Hospital, National Defense Medical Center, Taipei, Taiwan.
Int J Gen Med. 2021 Sep 2;14:5167-5174. doi: 10.2147/IJGM.S321605. eCollection 2021.
von Willebrand factor ristocetin cofactor activity (VWF:RCo) is the standard functional assay used for von Willebrand disease (VWD) diagnosis. However, it has some drawbacks including being time consuming and labor intensive and having high inter-laboratory variability. The HemosIL VWF activity assay has the advantages of both high speed and automation. The purpose of this study was to prospectively compare these two functional assays for type 1 VWD detection.
Plasma samples from 108 subjects were assessed in this study. HemosIL VWF activity was measured with the HemosIL latex immunoturbidimetric commercial kits by the ACL TOP coagulation analyzer. VWF:RCo was measured by platelet aggregation method. Pearson correlation analyses were performed to estimate the correlation of HemosIL VWF activity with VWF:RCo. Receiver-operator characteristic (ROC) curve analysis was used to evaluate the performance of the two diagnostic tests.
The correlation coefficient between VWF:RCo and HemosIL VWF activity was 0.874 overall and was 0.761 and 0.811 in the cohorts of type 1 VWD and non-VWD, respectively. The sensitivity and specificity of HemosIL VWF activity assay for type 1 VWD identification were 94.7% and 80.0%, respectively, and the ROC curve of HemosIL VWF activity was larger than that of VWF:RCo (0.928 vs 0.863, p=0.0138). Finally, the positive and negative predictive values of the HemosIL VWF activity assay for type 1 VWD detection were 72.0% and 96.6%, respectively.
Our results demonstrate that the HemosIL VWF activity assay was an effective method for type 1 VWD screening and diagnosis. It carried good sensitivity and specificity and had a higher ROC curve than VWF:RCo besides showing good correlation with VWF:RCo. With its advantages of greater speed and automated performance, these results suggest that the HemosIL VWF activity assay was reliable and precise in the clinical setting.
血管性血友病因子瑞斯托霉素辅因子活性（VWF:RCo）是用于血管性血友病（VWD）诊断的标准功能检测方法。然而，它存在一些缺点，包括耗时、劳动强度大以及实验室间变异性高。HemosIL VWF活性检测具有高速和自动化的优点。本研究的目的是前瞻性地比较这两种用于1型VWD检测的功能检测方法。
本研究评估了108名受试者的血浆样本。使用ACL TOP凝血分析仪通过HemosIL乳胶免疫比浊商业试剂盒测量HemosIL VWF活性。通过血小板聚集法测量VWF:RCo。进行Pearson相关性分析以估计HemosIL VWF活性与VWF:RCo的相关性。采用受试者操作特征（ROC）曲线分析来评估这两种诊断测试的性能。
VWF:RCo与HemosIL VWF活性之间的总体相关系数为0.874，在1型VWD和非VWD队列中分别为0.761和0.811。HemosIL VWF活性检测用于1型VWD识别的敏感性和特异性分别为94.7%和80.0%，HemosIL VWF活性的ROC曲线大于VWF:RCo的ROC曲线（0.928对0.863，p = 0.0138）。最后，HemosIL VWF活性检测用于1型VWD检测的阳性和阴性预测值分别为72.0%和96.6%。
我们的结果表明，HemosIL VWF活性检测是1型VWD筛查和诊断的有效方法。它具有良好的敏感性和特异性，与VWF:RCo具有良好的相关性，并且ROC曲线高于VWF:RCo。凭借其更高的速度和自动化性能优势，这些结果表明HemosIL VWF活性检测在临床环境中可靠且精确。
