Engineering Research Center for Biofluid Biopsy, Korea University, Seoul, Korea.
R&D Center, Rheomeditech. Inc., Seoul, Korea.
Clin Hemorheol Microcirc. 2021;78(4):439-448. doi: 10.3233/CH-211104.
Analyzing responsiveness to P2Y12 therapy is vital to preventing thrombotic and hemorrhagic complications in patients with cardiovascular diseases.
This study evaluates a new Anysis-P2Y12 assay system against VerifyNow-P2Y12 in cardiac patients and analyzes the P2Y12 low-response rates of the two devices with various cutoff values.
In total, 125 citrated blood samples were collected from cardiac patients referred for a P2Y12 antiplatelet response test. In the Anysis assay, the test result was the migration distance (MD) until the blood flow stops, which is comparable to both P2Y12 reaction units and percent inhibition obtained using VerifyNow.
The MDs without and with P2Y12 were 182±30 and 264±12 mm, respectively (p < 0.0001). Compared to VerifyNow-P2Y12, the sensitivity and specificity of Anysis-200 were 96.8% and 88.7%, respectively. Cohen's kappa coefficient between the two devices was 0.761, indicating a high agreement. However, there was an apparent difference in the low-response rate to P2Y12, which was 36.5% for VerifyNow and 5.9% for Anysis.
The performance of the newly developed platelet function assay, Anysis-P2Y12 was equivalent to that of VerifyNow-P2Y12 in terms of sensitivity and specificity. The Anysis-P2Y12 assay may help screen patients with abnormal P2Y12 non-responsiveness.
分析对 P2Y12 治疗的反应对于预防心血管疾病患者的血栓和出血并发症至关重要。
本研究评估了一种新的 Anysis-P2Y12 检测系统与 VerifyNow-P2Y12 在心脏患者中的对比，并分析了两种设备在不同截值下的 P2Y12 低反应率。
共收集了 125 份来自心脏患者的枸橼酸盐血液样本，这些患者被转介进行 P2Y12 抗血小板反应测试。在 Anysis 检测中，测试结果是血流停止时的迁移距离（MD），与使用 VerifyNow 获得的 P2Y12 反应单位和抑制百分比相当。
无 P2Y12 和有 P2Y12 的 MD 分别为 182±30 和 264±12 mm（p < 0.0001）。与 VerifyNow-P2Y12 相比，Anysis-200 的灵敏度和特异性分别为 96.8%和 88.7%。两种设备之间的 Cohen's kappa 系数为 0.761，表明高度一致。然而，P2Y12 低反应率存在明显差异，VerifyNow 为 36.5%，Anysis 为 5.9%。
新开发的血小板功能检测分析系统在灵敏度和特异性方面与 VerifyNow-P2Y12 相当。Anysis-P2Y12 检测可能有助于筛选出 P2Y12 反应异常的患者。
