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安西斯与 VerifyNow 阿司匹林检测的性能比较:评估心脏病患者的治疗性血小板抑制作用。

Performance comparison of aspirin assay between Anysis and VerifyNow: Assessment of therapeutic platelet inhibition in patients with cardiac diseases.

机构信息

Engineering Research Center for Biofluid Biopsy, Korea University, Seoul, Korea.

R&D Center, Rheomeditech. Inc., Seoul, Korea.

出版信息

Clin Hemorheol Microcirc. 2021;79(2):327-334. doi: 10.3233/CH-211171.

Abstract

BACKGROUND

Assessment of platelet inhibition for aspirin therapy is important to manage patients who are at potential risk of developing thrombotic and hemorrhagic complications.

OBJECTIVE

This study aimed to evaluate a new platelet assay (Anysis-aspirin), compare it with VerifyNow-aspirin in patients with cardiac diseases, and analyze the aspirin resistance rates between the two devices.

METHODS

Citrated blood samples were collected from patients with cardiac diseases referred for the aspirin response test. In the Anysis assay, a test result was provided with a blood flow migration distance (MD) until blood flow stoppage, which was comparable to aspirin reaction units (ARUs) obtained using VerifyNow. The measurements were simultaneously conducted using the two devices and compared.

RESULTS

The MD without and with aspirin use was 160±33 and 254±23 mm, respectively (p < 0.0001). Compared with VerifyNow (reference), the sensitivity and specificity of Anysis-200 were 96.3 and 90.3%, respectively (area under the curve, 0.968). Furthermore, the aspirin resistance rate in aspirin-administered patients was 20.9%using VerifyNow and 16.5%for Anysis-200. The Cohen's kappa coefficient between the two devices was 0.81, indicating an almost perfect agreement between the two devices.

CONCLUSIONS

Anysis-aspirin, a novel aspirin assay for assessing platelet inhibition, showed excellent agreement with VerifyNow-aspirin with high accuracy and precision. The Anysis-aspirin assay would be used as a point-of-care test to assess aspirin non-responsiveness and abnormal platelet reactivity.

摘要

背景

评估阿司匹林治疗的血小板抑制情况对于管理有发生血栓和出血并发症风险的患者非常重要。

目的

本研究旨在评估一种新的血小板检测方法(Anysis-aspirin),并将其与心脏病患者的 VerifyNow-aspirin 进行比较,分析两种设备之间的阿司匹林抵抗率。

方法

从心脏病患者中采集枸橼酸盐血液样本,用于阿司匹林反应测试。在 Anysis 检测中,提供了一个血流迁移距离(MD)的检测结果,直到血流停止,这与使用 VerifyNow 获得的阿司匹林反应单位(ARU)相当。同时使用两种设备进行测量并进行比较。

结果

无阿司匹林使用和使用阿司匹林时的 MD 分别为 160±33 和 254±23 mm(p < 0.0001)。与 VerifyNow(参考)相比,Anysis-200 的灵敏度和特异性分别为 96.3%和 90.3%(曲线下面积为 0.968)。此外,在使用阿司匹林的患者中,VerifyNow 检测的阿司匹林抵抗率为 20.9%,而 Anysis-200 检测的阿司匹林抵抗率为 16.5%。两种设备之间的 Cohen's kappa 系数为 0.81,表明两种设备之间具有几乎完美的一致性。

结论

评估血小板抑制的新型阿司匹林检测方法 Anysis-aspirin 与 VerifyNow-aspirin 具有出色的一致性,具有很高的准确性和精密度。Anysis-aspirin 检测将被用作一种即时检测方法,用于评估阿司匹林的无反应性和异常血小板反应性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d184/8673509/942eec23741f/ch-79-ch211171-g001.jpg

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