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Vladimirov, Alexander
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article
A Smartphone-Based Platform Assisted by Artificial Intelligence for Reading and Reporting Rapid Diagnostic Tests: Evaluation Study in SARS-CoV-2 Lateral Flow Immunoassays
Abstract
<jats:sec><jats:title>Background</jats:title><jats:p>Rapid diagnostic tests (RDTs) are being widely used to manage COVID-19 pandemic. However, many results remain unreported or unconfirmed, altering a correct epidemiological surveillance.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>Our aim was to evaluate an artificial intelligence–based smartphone app, connected to a cloud web platform, to automatically and objectively read RDT results and assess its impact on COVID-19 pandemic management.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Overall, 252 human sera were used to inoculate a total of 1165 RDTs for training and validation purposes. We then conducted two field studies to assess the performance on real-world scenarios by testing 172 antibody RDTs at two nursing homes and 96 antigen RDTs at one hospital emergency department.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Field studies demonstrated high levels of sensitivity (100%) and specificity (94.4%, CI 92.8%-96.1%) for reading IgG band of COVID-19 antibody RDTs compared to visual readings from health workers. Sensitivity of detecting IgM test bands was 100%, and specificity was 95.8% (CI 94.3%-97.3%). All COVID-19 antigen RDTs were correctly read by the app.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The proposed reading system is automatic, reducing variability and uncertainty associated with RDTs interpretation and can be used to read different RDT brands. The web platform serves as a real-time epidemiological tracking tool and facilitates reporting of positive RDTs to relevant health authorities.</jats:p></jats:sec>