LOS ANGELES - eTradeWire -- Cardiovascular diseases (CVDs) remain the leading cause of death worldwide, accounting for over 19 million fatalities annually. Early detection of acute myocardial infarction (AMI), commonly known as a heart attack, is essential for improving patient outcomes and reducing mortality rates. However, the high costs and infrastructure requirements associated with traditional laboratory-based diagnostic equipment often limit access to high-quality care, particularly in low- and middle-income regions.

To address this challenge, UCLA researchers developed a high-sensitivity vertical flow assay (hs-VFA) that combines the precision of traditional laboratory testing with the convenience and affordability of point-of-care technologies. Their findings demonstrate that this innovative platform can accurately quantify cTnI levels in just 15 minutes using a small sample of serum, making it ideal for rapid diagnostics in emergency settings or remote locations.

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The core of this platform lies in the integration of deep learning algorithms with cutting-edge nanoparticle amplification chemistry. The hs-VFA system uses time-lapse imaging and computational analysis to enhance the detection of cTnI—a key biomarker for cardiac damage—achieving a detection limit as low as 0.2 picograms per milliliter (pg/mL). This level of sensitivity surpasses current point-of-care devices by a significant margin and meets the clinical requirements for high-sensitivity troponin testing, which is essential for the early diagnosis of AMI.

In rigorous testing using both spiked and clinical serum samples, the hs-VFA demonstrated high precision with a coefficient of variation (CV) of less than 7%. It also exhibited a strong correlation with gold-standard laboratory analyzers. Importantly, the hs-VFA also demonstrated an extensive dynamic range, covering cTnI concentrations from 0.2 pg/mL to 100 nanograms per milliliter (ng/mL). This range makes it suitable not only for diagnosing heart attacks but also for monitoring at-risk patients over time.

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The paper-based assay costs less than $4 per test, while the portable reader, designed using a Raspberry Pi computer and off-the-shelf components, costs approximately $170 per unit. This affordability is crucial for expanding access to high-quality diagnostics in low-resource settings, where traditional laboratory infrastructure may be unavailable.

Beyond cardiac diagnostics, the researchers believe the hs-VFA platform could be adapted for other critical low-abundance biomarkers, broadening its potential applications to various areas of medical diagnostics. The portability, simplicity, and affordability of the platform position it as a viable alternative to centralized laboratory testing for many conditions, offering hope for improved health outcomes on a global scale.

This research was supported by the US National Science Foundation (NSF) PATHS-UP Engineering Research Center.

Publication: https://pubs.acs.org/doi/10.1021/acsnano.4c05153