한빛사논문
Seong Jun Park1,12, Seungmin Lee1,2,12, Dongtak Lee2,12, Na Eun Lee1,3, Jeong Soo Park1, Ji Hye Hong1,2, Jae Won Jang2,4, Hyunji Kim2,4, Seokbeom Roh5,6, Gyudo Lee5,6, Dongho Lee7, Sung-Yeon Cho8,9, Chulmin Park8, Dong-Gun Lee8,9, Raeseok Lee8,9, Dukhee Nho8,9, Dae Sung Yoon2,4,10,13, Yong Kyoung Yoo11,13 & Jeong Hoon Lee1,13
1Department of Electrical Engineering, Kwangwoon University, 20 Kwangwoon-ro, Nowon, Seoul 01897, Republic of Korea.
2School of Biomedical Engineering, Korea University, 145 Anam-ro, Seongbuk, Seoul 02841, Republic of Korea.
3Department of Biotechnology, College of Life Sciences and Biotechnology, Korea University, Seoul 02841, Republic of Korea.
4Interdisciplinary Program in Precision Public Health, Korea University, Seoul 02841, Republic of Korea.
5Department of Biotechnology and Bioinformatics, Korea University, Sejong 30019, Republic of Korea.
6Interdisciplinary Graduate Program for Artificial Intelligence Smart Convergence Technology, Korea University, Sejong 30019, Korea.
7CALTH Inc., Changeop-ro 54, Seongnam, Gyeonggi 13449, Republic of Korea.
8Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
9Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
10Astrion Inc, Seoul 02841, Republic of Korea.
11Department of Electronic Engineering, Catholic Kwandong University, 24, Beomil-ro 579 beon-gil, Gangneung-si, Gangwon-do 25601, Republic of Korea.
12These authors contributed equally: Seong Jun Park, Seungmin Lee, Dongtak Lee.
13These authors jointly supervised this work: Dae Sung Yoon, Yong Kyoung Yoo, Jeong Hoon Lee.
Corresponding authors : Correspondence to Dae Sung Yoon, Yong Kyoung Yoo or Jeong Hoon Lee.
Abstract
Highly sensitive rapid testing for COVID-19 is essential for minimizing virus transmission, especially before the onset of symptoms and in asymptomatic cases. Here, we report bioengineered enrichment tools for lateral flow assays (LFAs) with enhanced sensitivity and specificity (BEETLES2), achieving enrichment of SARS-CoV-2 viruses, nucleocapsid (N) proteins and immunoglobulin G (IgG) with 3-minute operation. The limit of detection is improved up to 20-fold. We apply this method to clinical samples, including 83% with either intermediate (35%) or low viral loads (48%), collected from 62 individuals (n = 42 for positive and n = 20 for healthy controls). We observe diagnostic sensitivity, specificity, and accuracy of 88.1%, 100%, and 91.9%, respectively, compared with commercial LFAs alone achieving 14.29%, 100%, and 41.94%, respectively. BEETLES2, with permselectivity and tunability, can enrich the SARS-CoV-2 virus, N proteins, and IgG in the nasopharyngeal/oropharyngeal swab, saliva, and blood serum, enabling reliable and sensitive point-of-care testing, facilitating fast early diagnosis.
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