TY - JOUR
T1 - A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing
AU - Macchia, Eleonora
AU - Kovács-Vajna, Zsolt M.
AU - Loconsole, Daniela
AU - Sarcina, Lucia
AU - Redolfi, Massimiliano
AU - Chironna, Maria
AU - Torricelli, Fabrizio
AU - Torsi, Luisa
N1 - Publisher Copyright:
© 2022 The Authors.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85133865564&partnerID=8YFLogxK
U2 - 10.1126/sciadv.abo0881
DO - 10.1126/sciadv.abo0881
M3 - Article
C2 - 35857467
AN - SCOPUS:85133865564
SN - 2375-2548
VL - 8
JO - Science Advances
JF - Science Advances
IS - 27
M1 - abo0881
ER -