Comparative evaluation of 15-minute rapid diagnosis of ischemic heart disease by high-sensitivity quantification of cardiac biomarkers.

Abstract

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.