Development and preliminary validation of infrared spectroscopic device for transdermal assessment of elevated cardiac troponin

Titus et al. develop a technological platform for the non-invasive transdermal measurement of cardiac troponin-I, a marker of myocardial injury. Preliminary testing of their device, which works via infrared spectroscopy, indicates that troponin can be detected with reasonable performance, in the absence of a blood draw. Plain language summaryThe number one cause of death in the US is heart disease. With 10 million patients visiting the emergency departments in a year with chest pain, 8 million are unrelated to cardiac issues. This places a burden on hospitals leading to suboptimal patient outcomes. In patients with cardiac issues, the time clinicians take to intervene dictates reversible or irreversible heart damage. However, current markers used to test for cardiac issues require blood sampling, limiting access to and frequency of testing. This study introduces a non-invasive cardiac marker measurement device without any form of blood draw, based on measurements taken by a wearable device through the skin. Preliminary studies show high conformance to the standard of care technologies, indicating that the technology has potential to enable more rapid, frequent, accessible and non-invasive detection of cardiac issues such as heart attacks. BackgroundThe levels of circulating troponin are principally required in addition to electrocardiograms for the effective diagnosis of acute coronary syndrome. Current standard-of-care troponin assays provide a snapshot or momentary view of the levels due to the requirement of a blood draw. This modality further restricts the number of measurements given the clinical context of the patient. In this communication, we present the development and early validation of non-invasive transdermal monitoring of cardiac troponin-I to detect its elevated state.MethodsOur device relies on infrared spectroscopic detection of troponin-I through the dermis and is tested in stepwise laboratory, benchtop, and clinical studies. Patients were recruited with suspected acute coronary syndrome.ResultsWe demonstrate a significant correlation (r = 0.7774, P < 0.001, n = 52 biologically independent samples) between optically-derived data and blood-based immunoassay measurements with and an area under receiver operator characteristics of 0.895, sensitivity of 96.3%, and specificity of 60% for predicting a clinically meaningful threshold for defining elevated Troponin I.ConclusionThis preliminary work introduces the potential of a bloodless transdermal measurement of troponin-I based on molecular spectroscopy. Further, potential pitfalls associated with infrared spectroscopic mode of inquiry are outlined including requisite steps needed for improving the precision and overall diagnostic value of the device in future studies.

Automated summary

The study introduces a non-invasive cardiac marker measurement device that does not require blood draw, based on measurements taken by a wearable device through the skin. Preliminary studies show high conformance to standard of care technologies, indicating the potential for more rapid, frequent, accessible, and non-invasive detection of cardiac issues such as heart attacks.