A Fully Automated Point‐of‐Care Device Using Organic Electrochemical Transistor‐Enhanced CRISPR/Cas12a for Amplification‐Free Nucleic Acid Detection

Abstract Conventional nucleic acid detection methods often involve complex, time‐consuming amplification procedures and rely on sophisticated equipment, rendering them incapable of serving end customers or community hospitals. Here, a miniaturized and automated point‐of‐care (POC) molecular diagnostic device is described that amplification‐free detects, via organic electrochemical transistors (OECTs) enhanced CRISPR/Cas12a system, achieving disease‐associated nucleic acids in real sample at attomolar level within 55 min. The device enables automated sample‐to‐answer analysis via the structural integration of a microfluidic control system, microfluidic chip, and wireless transmission module. Moreover, the device can rapidly distinguish severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) positive and negative patients with an accuracy of 97.4% using 13 pharyngeal swab samples. Besides, it is also shown that the device can detect various nucleic acid including in Staphylococcus aureus ( S. aureu s) and tumor cell by merely redesigning the gRNA regions of the CRISPR/Cas12a. Overall, this work provides an automated and customizable POC device that may facilitate diseases digital surveillance.