Wu Yen-Wen, Yeh Yen-Ting, Wu Chih-Cheng, Huang Chi-Lun, Chang Yi-Yao, Wu Chau-Chung
Cardiology Division of Cardiovascular Medical Center, Far Eastern Memorial Hospital, New Taipei City.
National Yang-Ming University School of Medicine.
Acta Cardiol Sin. 2020 Nov;36(6):649-659. doi: 10.6515/ACS.202011_36(6).20200414A.
The rapid diagnosis of acute myocardial infarction (AMI) is a clinical and operational priority in emergency departments. Serial serum levels of cardiac biomarkers play a crucial role in the evaluation of patients presenting with acute chest pain, so that an accurate and rapidly responsive assay of cardiac biomarkers is vital for emergency departments.
Immunomagnetic reduction (IMR) has been developed for rapid and on-site assays with a small sample volume. IMR kits for three biomarkers [myoglobin, creatine kinase-MB (CK-MB), and troponin-I] have been developed by MagQu Co., Ltd., Taiwan (US patent: US20190072563A1). In this study, we examined correlations between IMR signals and biomarker concentrations. The measurement threshold of the IMR kits, dynamic ranges, interference tests in vitro, and reagent stability were tested. Clinical cases were included with serial IMR measurements to determine the time course and peak of IMR-measured cardiac biomarkers after AMI.
The correlations between IMR signals and biomarker concentrations fitted well to logistic functions. The measurement thresholds of the IMR kits (1.03 × 10 ng/mL for myoglobin, 1.46 × 10 ng/mL for CK-MB, and 0.08 ng/mL for troponin-I) were much lower than the levels detected in the patients with AMI. There was no significant interference in vitro. The peak times of IMR-detected myoglobin, CK-MB, and troponin-I after AMI were 8.2 hours, 24.4 hours, and 24.7 hours, respectively.
IMR is an accurate and sensitive on-site rapid assay for multiple cardiac biomarkers in vitro, and may play a role in the early diagnosis of AMI. Clinical trials are needed.
急性心肌梗死(AMI)的快速诊断是急诊科临床和工作的重点。连续测定血清心脏生物标志物水平在评估急性胸痛患者中起着关键作用,因此,一种准确且反应迅速的心脏生物标志物检测方法对急诊科至关重要。
免疫磁珠法(IMR)已被开发用于小样本量的快速现场检测。台湾麦格昆公司(美国专利:US20190072563A1)已开发出用于检测三种生物标志物[肌红蛋白、肌酸激酶同工酶MB(CK-MB)和肌钙蛋白I]的IMR试剂盒。在本研究中,我们检测了IMR信号与生物标志物浓度之间的相关性。测试了IMR试剂盒的测量阈值、动态范围、体外干扰试验和试剂稳定性。纳入临床病例进行连续IMR测量,以确定AMI后IMR检测的心脏生物标志物的时间进程和峰值。
IMR信号与生物标志物浓度之间的相关性与逻辑函数拟合良好。IMR试剂盒的测量阈值(肌红蛋白为1.03×10 ng/mL,CK-MB为1.46×10 ng/mL,肌钙蛋白I为0.08 ng/mL)远低于AMI患者检测到的水平。体外无明显干扰。AMI后IMR检测到的肌红蛋白、CK-MB和肌钙蛋白I的峰值时间分别为8.2小时、24.4小时和24.7小时。
IMR是一种准确、灵敏的体外多种心脏生物标志物现场快速检测方法,可能在AMI的早期诊断中发挥作用。需要进行临床试验。