Wang Yang, Li Kaiju, Xu Gaolian, Chen Chuan, Song Guiqin, Dong Zaizai, Lin Long, Wang Yu, Xu Zhiyong, Yu Mingxia, Yu Xinge, Ying Binwu, Fan Yubo, Chang Lingqian, Geng Jia
Beijing Advanced Innovation Center for Biomedical Engineering, Key Laboratory for Biomechanics and Mechanobiology, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China.
Department of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu 610041, China.
Research (Wash D C). 2021 Mar 12;2021:2813643. doi: 10.34133/2021/2813643. eCollection 2021.
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.
对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）进行灵敏检测对于抑制当前的新型冠状病毒肺炎（COVID-19）大流行至关重要。在此，我们报告了一个简单而高效的平台，该平台集成了一个便携式低成本定制检测仪和一种新型微孔阵列生物芯片，用于快速准确地检测SARS-CoV-2。该仪器显示出加快的扩增速度，能够在25分钟内实现比色读出。基于逆转录环介导等温扩增（RT-LAMP），开发了一种带有激光雕刻微孔阵列的聚合物芯片，以处理引物与呼吸道拭子RNA提取物之间的反应。为了实现临床可接受的性能，我们合成了一组六种引物，以识别SARS-CoV-2开放阅读框1ab（ORF1ab）基因的保守区域。对87份聚合酶链反应（PCR）阳性和43份PCR阴性患者样本进行了临床试验。该平台显示出高灵敏度（95.40%）和高特异性（95.35%），在许多其他传染性病原体中展现出对COVID-19进行快速且用户友好诊断的潜力。
