TY - JOUR AU - Bermejo-Peláez, David AU - Marcos-Mencía, Daniel AU - Álamo, Elisa AU - Pérez-Panizo, Nuria AU - Mousa, Adriana AU - Dacal, Elena AU - Lin, Lin AU - Vladimirov, Alexander AU - Cuadrado, Daniel AU - Mateos-Nozal, Jesús AU - Galán, Juan Carlos AU - Romero-Hernandez, Beatriz AU - Cantón, Rafael AU - Luengo-Oroz, Miguel AU - Rodriguez-Dominguez, Mario PY - 2022 DA - 2022/12/30 TI - A Smartphone-Based Platform Assisted by Artificial Intelligence for Reading and Reporting Rapid Diagnostic Tests: Evaluation Study in SARS-CoV-2 Lateral Flow Immunoassays JO - JMIR Public Health Surveill SP - e38533 VL - 8 IS - 12 KW - rapid diagnostic test KW - artificial intelligence KW - AI KW - telemedicine platform KW - COVID-19 KW - rapid test KW - diagnostics KW - epidemiology KW - surveillance KW - automatic KW - automated KW - tracking AB - Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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. SN - 2369-2960 UR - https://publichealth.jmir.org/2022/12/e38533 UR - https://doi.org/10.2196/38533 UR - http://www.ncbi.nlm.nih.gov/pubmed/36265136 DO - 10.2196/38533 ID - info:doi/10.2196/38533 ER -