Assessing the Performance of a Novel Point-of-Care Qualitative Assay for Early Diagnosis of Acute Coronary Syndrome.

Autor:	Alcalai R; Heart Institute, Hadassah Medical Center, Jerusalem, Israel, ronny@hadassah.org.il., Varshisky B; Heart Institute, Hadassah Medical Center, Jerusalem, Israel., Marhig A; Department of Emergency Medicine, Hadassah Medical Center, Mount Scopus, Jerusalem, Israel., Leibowitz D; Heart Institute, Hadassah Medical Center, Jerusalem, Israel., Kogan-Boguslavsky L; Heart Institute, Hadassah Medical Center, Jerusalem, Israel., Dorfman E; Novamed, Ltd., Jerusalem, Israel., Steiner D; Novamed, Ltd., Jerusalem, Israel., Katz E; Novamed, Ltd., Jerusalem, Israel., Salameh S; Department of Emergency Medicine, Hadassah Medical Center, Mount Scopus, Jerusalem, Israel., Lotan C; Heart Institute, Hadassah Medical Center, Jerusalem, Israel.
Jazyk:	angličtina
Zdroj:	Cardiology [Cardiology] 2021; Vol. 146 (1), pp. 34-41. Date of Electronic Publication: 2020 Nov 30.
DOI:	10.1159/000511435
Abstrakt:	Background: Early and accurate diagnosis of acute coronary syndrome (ACS) is essential for initiating lifesaving interventions. In this article, the diagnostic performance of a novel point-of-care rapid assay (SensAheart©) is analyzed. This assay qualitatively determines the presence of 2 cardiac biomarkers troponin I and heart-type fatty acid-binding protein that are present soon after onset of myocardial injury. Methods: We conducted a prospective observational study of consecutive patients who presented to the emergency department with typical chest pain. Simultaneous high-sensitive cardiac troponin T (hs-cTnT) and SensAheart testing was performed upon hospital admission. Diagnostic accuracy was computed using SensAheart or hs-cTnT levels versus the final diagnosis defined as positive/negative. Results: Of 225 patients analyzed, a final diagnosis of ACS was established in 138 patients, 87 individuals diagnosed with nonischemic chest pain. In the overall population, as compared to hs-cTnT, the sensitivity of the initial SensAheart assay was significantly higher (80.4 vs. 63.8%, p = 0.002) whereas specificity was lower (78.6 vs. 95.4%, p = 0.036). The overall diagnostic accuracy of SensAheart assay was similar to the hs-cTnT (82.7% compared to 76.0%, p = 0.08). Conclusions: Upon first medical contact, the novel point-of-care rapid SensAheart assay shows a diagnostic performance similar to hs-cTnT. The combination of 2 cardiac biomarkers in the same kit allows for very early detection of myocardial damage. The SensAheart assay is a reliable and practical tool for ruling-in the diagnosis of ACS. (© 2020 S. Karger AG, Basel.)
Databáze:	MEDLINE
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