He Shengnan, Qu Long, He Xi, Zhang Dan, Xie Ni
Institute of Translational Medicine, Health Science Center, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong 518035, P.R. China.
Exp Ther Med. 2020 Aug;20(2):1702-1708. doi: 10.3892/etm.2020.8853. Epub 2020 Jun 10.
A rapid clinical diagnosis may efficiently improve the survival rate and prognosis of patients with ischemic heart disease (IHD). Therefore, a one-step, rapid and inexpensive analysis for the quick diagnosis of IHD was investigated in the present study. Consecutive patients who were subjected to myoglobin, cardiac troponin I and creatine kinase-MB isoenzyme assessment at the Emergency Department of Shenzhen Second People's Hospital (Shenzhen, China) between December 2017 and March 2018 prior to treatment were screened. Clinically applicable disposable strips were employed for quantification of the cardiac biomarkers. The analytical performance of the strips was evaluated by receiver operating characteristic (ROC) curves and compared with the traditional chemiluminescence immunoassay (CLIA) method. The data of 391 participants were collected. At the baseline, 57 patients were diagnosed with IHD and 334 patients were diagnosed with other diseases. The area under the ROC curve (AUC) of the CLIA model was 0.787 (95% CI, 0.709-0.865) with a specificity of 76.7% and a sensitivity of 71.9%. At the optimal cutoff value of -1.867, the negative and the positive predictive value were 94.1 and 34.5%, respectively. The AUC of the disposable strip model was 0.792 (95% CI, 0.729-0.855). At the cutoff value of -1.820 or below, the negative predictive value was 94.9%, the positive predictive value was 28.9%, the specificity was 66.8% and the sensitivity was 79.0%. The P-value of the ROCs was 0.858, indicating no statistically significant difference between the two assay methods. The cost of the disposable strip was 50% of that of the CLIA method and it took only 25% of the time that was required for the quantification of the three cardiac markers by CLIA. In conclusion, the disposable strip provides a platform for point-of-care testing and may be an easy, rapid, reliable and cost-saving method for the diagnosis of IHD.
快速的临床诊断可有效提高缺血性心脏病（IHD）患者的生存率和预后。因此，本研究探索了一种用于IHD快速诊断的一步法、快速且低成本的分析方法。对2017年12月至2018年3月期间在深圳市第二人民医院急诊科（中国深圳）接受治疗前进行肌红蛋白、心肌肌钙蛋白I和肌酸激酶-MB同工酶评估的连续患者进行筛选。使用临床适用的一次性试纸条对心脏生物标志物进行定量。通过受试者工作特征（ROC）曲线评估试纸条的分析性能，并与传统化学发光免疫分析（CLIA）方法进行比较。收集了391名参与者的数据。基线时，57名患者被诊断为IHD，334名患者被诊断为其他疾病。CLIA模型的ROC曲线下面积（AUC）为0.787（95%CI，0.709-0.865），特异性为76.7%，敏感性为71.9%。在最佳临界值-1.867时，阴性预测值和阳性预测值分别为94.1%和34.5%。一次性试纸条模型的AUC为0.792（95%CI，0.729-0.855）。在临界值为-1.820或更低时，阴性预测值为94.9%，阳性预测值为28.9%，特异性为66.8%，敏感性为79.0%。ROC曲线的P值为0.858，表明两种检测方法之间无统计学显著差异。一次性试纸条的成本是CLIA方法的50%，且其定量三种心脏标志物所需时间仅为CLIA方法的25%。总之，一次性试纸条为即时检测提供了一个平台，可能是一种用于IHD诊断的简便、快速、可靠且节省成本的方法。
