Transforming Antigenic Portable Technologies into Highly Dependable Screening Devices

The emerging field of ionic and electronic devices for biosensing applications, holds promise for advancing the development of innovative diagnostic technologies. The endeavor to screen asymptomatic organisms, encompassing humans, animals, and plants, through the utilization of point-of-care-testing (POCT) technologies boasting high diagnostic accuracy is both visionary and promising. Efficient surveillance necessitates the development of user-friendly, cost-effective, and highly reliable in-vitro diagnostic devices that are ultra-portable and readily deployable as needed. While such devices are not yet commercially available, there are encouraging advancements at readiness-level 5, notably the Clustered-Regularly-Interspaced-Short-Palindromic-Repeats (CRISPR) lateral-flow-strip tests and the Single-Molecule-with-a-large-Transistor (SiMoT) bioelectronic palmar devices.<br/>These technologies embody essential features as stipulated by the World Health Organization for POCT systems, exhibiting a minimal occurrence of false-positive and false-negative errors (&lt;1-5%) and ensuring diagnostic selectivity and sensitivity (&gt; 95 – 99 %). Furthermore, they offer a low limit of detection for various markers. The CRISPR-strip functions as a molecular assay, capable of detecting even a few copies of DNA/RNA markers in blood, while the SiMoT test can identify single oligonucleotides, protein markers, or pathogens in a minute sample of blood, saliva, or olive sap.<br/>SiMoT single-sensor prototype, comprising a palmar electronic-reader and a disposable bioelectronic-cartridge, will reach TRL7 in a couple of years at most through a clinical-trial kicked-off in February 2024 involving 1.500 assays of peripheral-fluids (urine/plasma/serum) from oncological patients. This effort is conducted within the Apulian Regional Innovation-Center for Single-Molecule Digital-Assay (www.singlemolecule.center), chaired by Torsi, at the "Giovanni Paolo II" Scientific Institute for Research, Hospitalization, and Healthcare, the main oncological hospital in Bari.<br/>The SiMoT technological breakthrough hold the potential to enable systematic and dependable surveillance of asymptomatic individuals prior to the aggravation or spread of illnesses, thereby facilitating timely diagnosis and prognosis. This proactive approach could establish a healthcare ecosystem that delivers effective treatments to all living organisms, fostering widespread well-being at manageable costs.<br/><br/>References<br/>- E. Genco et al., <i>A Single-Molecule Bioelectronic Portable Array for Early Diagnosis of Pancreatic Cancer Precursors.</i> Advanced Materials 2023, 202304102; <i>featured in the main cover.</i><br/>- E. Macchia et al., <i>Point-Of-Care Ultra-Portable Single-Molecule Bioassays for One-Health</i>. Advanced Materials 2023, 202309705; <i>featured in the main cover</i>.<br/>- E. Macchia et al<i>.,</i> <i>A handheld intelligent single-molecule binary bioelectronic system for fast and reliable im-munometric point-of-care testing</i>. Science Advances 6 Jul 2022 Vol 8, Issue 27.<br/>- E. Macchia et al., <i>Large-Area Interfaces for Single-Molecule Label-free Bioelectronic Detection</i>, Chemical Reviews, 2022,122, 4, 4636-4699.<br/>- L. Sarcina et al., Fast and Reliable Electronic Assay of a Xylella fastidiosa Single Bacterium in In-fected Plants Sap<br/>Advanced Science 2022, 2203900<br/>- F. Torricelli, et al. <i>Electrolyte-gated transistors for enhanced performance bioelectronics</i>. Nature Reviews Methods Primers 2021 1, Article number: 66.