Journal Article

Low-Cost and Scalable Platform with Multiplexed Microwell Array Biochip for Rapid Diagnosis of COVID-19

Yu, Xinge, Wang, Yu, Li, Kaiju, Xu, Zhiyong, Xu, Gaolian, Fan, Yubo, Geng, Jia, Chang, Lingqian, Yu, Mingxia, Wang, Yang, Dong, Zaizai, Song, Guiqin, Chen, Chuan, Long, Lin, Binwu Ying

2021

Overview

Sensitive detection of SARS-CoV-2 is of great importance for inhibiting the current pandemic of COVID-19. Here, we report a simple yet efficient platform integrating a portable and low-cost custom-made detector and a novel microwell array biochip for rapid and accurate detection of SARS-CoV-2. The instrument exhibits expedited amplification speed that enables colorimetric read-out within 25 minutes. A polymeric chip with a laser-engraved microwell array was developed to process the reaction between the primers and the respiratory swab RNA extracts, based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP). To achieve clinically acceptable performance, we synthesized a group of six primers to identify the conserved regions of the ORF1ab gene of SARS-CoV-2. Clinical trials were conducted with 87 PCR-positive and 43 PCR-negative patient samples. The platform demonstrated both high sensitivity (95.40%) and high specificity (95.35%), showing potentials for rapid and user-friendly diagnosis of COVID-19 among many other infectious pathogens.

• Subject: Biochips / Clinical trials / Colorimetry / COVID-19 / Diagnosis / Engraving / Gene amplification / Laser arrays / Low cost / Polymerase chain reaction / RNA-directed DNA polymerase / Severe acute respiratory syndrome coronavirus 2 / Viral diseases