(K-419) Developing and Validating a Portable Troponin Testing Device to Advance Cardiac Care

Introduction:: The goal of this research was to create a troponin testing device that measured troponin levels in blood samples using a small and simple handheld device. The significance of this work stems from its ability to provide objective evidence of cardiac muscle injury, assisting in the appropriate diagnosis of a heart attack or other cardiac-related disorders, as troponin levels in the blood may indicate if a patient is having or has recently had a heart attack. Assessing troponin levels on-site remains a need as quantitative, portable techniques are not available. The purpose of this work was to overcome this issue by developing a device that could quickly deliver a quantitative assay of troponin levels using a disposable test strip for collecting blood from droplets created by pin prick using capillary action and assessment by anti-troponin antibodies binding. The precise goals of this project were to properly identify increasing troponin levels which would make rapid application of appropriate medication possible, and support healthcare practitioners in patient management by assisting in risk classification and evaluating the severity of cardiac events. By delivering fast and reliable troponin level readings, we hope to improve decision-making and early responsiveness in treating cardiac muscle damage, such as a heart attack. The purpose of this project was to create a novel handheld gadget for monitoring troponin levels that would benefit both healthcare professionals and patients while improving patient outcomes.

Materials and Methods::

The device is designed to be handheld and for blood samples to be generated by a fingertip pinprick similar to that seen for monitoring glucose. Our system optimization involved assuring that sample volume, which ranged from 50 to 200 microliters, could be adequate for accurate troponin-level assessments. The blood samples are collected using the small, disposable cartridges within the device, allowing quantitative assessment in only a few minutes. The data is displayed on a clear and readable screen to reveal the troponin levels in the blood. The device is to provide precise findings within the specified troponin concentration range in blood, from 0.01 ng/ml to 1 ng/ml. We classify samples as healthy when troponin levels are from 0.01 to 0.04 ng/ml, having mild heart issues from 0.04 to 0.39 ng/ml, or likely experiencing cardiac arrest when above 0.40 ng/ml. The samples are to be provided within 5-10 minutes after sample processing, stabilization, and presentation on the device's screen.

Results, Conclusions, and Discussions::

We anticipate that from our tests using known troponin amounts of varying concentrations in blood samples we may assess the device’s accuracy and precision. Due to the high selectivity of the antibodies, we expect the device will have no cross-reactivity with compounds other than troponin to avoid false-positive results. For estimating sensitivity, mock blood samples with serially diluted troponin concentrations are expected to yield device detection limits below the 0.01 ng/mL concentration needed. The device is expected to be user-friendly with an overall positive user experience of greater than 90% and the speed of providing an accurate troponin level testing will be within 5 minutes. The success of this project could provide a technology that could improve stratification of patients in need of cardiac care.

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Research reported in this publication was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number R25EB032766. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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