Affiliations: [a]
Engineering Research Center for Biofluid Biopsy, Korea University, Seoul, Korea
| [b]
R&D Center, Rheomeditech. Inc., Seoul, Korea
| [c]
Division of Cardiology, Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea
| [d]
School of Mechanical Engineering, Korea University, Seoul, Korea
Correspondence:
[*]
Corresponding authors: Cheol Ung Choi, MD, Ph.D., Division of Cardiology, Department of Internal Medicine, Guro Hospital, Korea University College of Medicine, Seoul 06273, South Korea. E-mail: wmagpie@korea.ac.kr; Sehyun Shin, Ph.D., School of Mechanical Engineering, Korea University, Seoul 02841, South Korea. Tel.: +82 2 3290 3377; Fax: +82 2 928 5825; E-mail: lexerdshin@korea.ac.kr.
Abstract: BACKGROUND:Analyzing responsiveness to P2Y12 therapy is vital to preventing thrombotic and hemorrhagic complications in patients with cardiovascular diseases. OBJECTIVE: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.
