Deep Learning‐Enhanced Chemiluminescence Vertical Flow Assay for High‐Sensitivity Cardiac Troponin I Testing
Gyeo‐Re Han, Artem Goncharov, Merve Eryılmaz, Shun Ye, Hyou‐Arm Joung, Rajesh Ghosh, Emily O. Ngo, Aoi Tomoeda, Yena Lee, Kevin Ngo, Elizabeth Melton, Omai B. Garner, Dino Di Carlo, Aydogan Özcan
Abstract
Abstract Democratizing biomarker testing at the point‐of‐care requires innovations that match laboratory‐grade sensitivity and precision in an accessible format. Here, high‐sensitivity detection of cardiac troponin I (cTnI) is demonstrated through innovations in chemiluminescence‐based sensing, imaging, and deep learning‐driven analysis. This chemiluminescence vertical flow assay (CL‐VFA) enables rapid, low‐cost, and precise quantification of cTnI, a key cardiac protein for assessing heart muscle damage and myocardial infarction. The CL‐VFA integrates a user‐friendly chemiluminescent paper‐based sensor, a polymerized enzyme‐based conjugate, a portable high‐performance CL reader, and a neural network‐based cTnI concentration inference algorithm. The CL‐VFA measures cTnI over a broad dynamic range covering six orders of magnitude and operates with 50 µL of serum per test, delivering results in 25 min. This system achieves a detection limit of 0.16 pg mL −1 with an average coefficient of variation under 15%, surpassing traditional benchtop analyzers in sensitivity by an order of magnitude. In blinded validation, the computational CL‐VFA accurately measures cTnI concentrations in patient samples, demonstrating a robust correlation against a clinical‐grade FDA‐cleared analyzer. These results highlight the potential of CL‐VFA as a robust diagnostic tool for accessible, rapid cardiac biomarker testing that meets the needs of diverse healthcare settings, from emergency care to underserved regions.