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

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

16 Citations (Scopus)
82 Downloads (Pure)

Abstract

Molecular tests are highly reliable and sensitive but lack portability and are not simple to use; conversely, easy-touse 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.

Original languageEnglish
Article numberabo0881
JournalScience Advances
Volume8
Issue number27
DOIs
Publication statusPublished - Jul 2022
MoE publication typeA1 Journal article-refereed

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