A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing
Eleonora Macchia, Zsolt M. Kovács‐Vajna, Daniela Loconsole, Lucia Sarcina, Massimiliano Redolfi, Maria Chironna, Fabrizio Torricelli, Luisa Torsi
Abstract
Molecular tests are highly reliable and sensitive but lack portability and are not simple to use; conversely, easy-to-use antigenic tests still lack high performance. BioScreen combines single-molecule sensitivity and outstanding reliability with ultraportability and simplicity of use. This digital platform is capable of artificial intelligence-based binary classification at the limit of identification of a single marker/virus in 0.1 ml. The diagnostic sensitivity, specificity, and accuracy reach 99.2% as validated through 240 assays, including a pilot clinical trial. The versatile immunometric system can detect the SARS-CoV-2 virus, spike S1, and immunoglobulin G antigen proteins in saliva, blood serum, and swab. BioScreen has a small footprint comprising a disposable cartridge and a handheld electronic reader connected to a smart device. The sample handling is minimal, and the assay time to result is 21 min. Reliable and sensitive self-testing with an ultraportable and easy-to-use diagnostic system operated directly by a patient holds the potential to revolutionize point-of-care testing and early diagnosis.