Self-Directed Molecular Diagnostics (SdMDx) System for COVID-19 via One-Pot Processing

35 Pages Posted: 26 Sep 2022

See all articles by Yoon Ok Jang

Yoon Ok Jang

Yonsei University

Nam Hun Kim

INFUSIONTECH

Yeonjeong Roh

Yonsei University

Bonhan Koo

University of Ulsan - Asan Medical Center

Ji Yeun Kim

University of Ulsan

Sung-Han Kim

University of Ulsan

Yong Shin

Yonsei University - Department of Biotechnology; University of Ulsan - Department of Convergence Medicine

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Abstract

Rapid, sensitive, and specific detection of the severe acute respiratory syndrome coronavirus (SARS-CoV)-2 during early infection is pivotal in controlling the spread and pathological progression of Coronavirus Disease 2019 (COVID-19). Thus, highly accurate, affordable, and scalable point-of-care (POC) diagnostic technologies are necessary. Herein, we developed a rapid and efficient self-directed molecular diagnostic (SdMDx) system for SARS-CoV-2. This system combines the sample preparation step, including virus enrichment and extraction processes, which involve dimethyl suberimidate dihydrochloride and diatomaceous earth functionalized with 3-aminopropyl(diethoxy)methylsilane, and the detection step using loop-mediated isothermal amplification-lateral flow assay (LAMP-LFA). Using the SdMDx system, SARS-CoV-2 could be detected within 47 min by hand without the need for any larger instruments. The SdMDx system enabled detection as low as 0.05 PFU in the culture fluid of SARS-CoV-2-infected VeroE6 cells. We validated the accuracy of the SdMDx system on 38 clinical nasopharyngeal specimens. The clinical utility of the SdMDx system for targeting the S gene of SARS-CoV-2 showed 94.4% sensitivity and 100% specificity. This system is more sensitive than antigen and antibody assays, and it minimizes the use of complicated processes and reduces contamination risks. Accordingly, we demonstrated that the SdMDx system enables a rapid, accurate, simple, efficient, and inexpensive detection of SARS-CoV-2 at home, in emergency facilities, and in low-resource sites as a pre-screening platform and POC testing through self-operation and self-diagnosis.

Note:

Funding Information: This study was supported by the Korea Medical Device Development Fund grant funded by the Korea government (Project Number: HW20C2062), and also supported by the Ministry of Science, ICT and Future Planning (MSIP) through the National Research Foundation of Korea (NRF) (2020R1A2C2007148), and also supported by the National Research Council of Science & Technology (NST) grant by the Korea government (MSIT) (CRC-20-02-KIST).

Declaration of Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Ethics Approval Statement: This study was reviewed and approved by the ethics committee of the institutional review board of the Asan Medical Center, and all the participants provided written informed consent. All the experimental procedures were performed following the guidelines approved by the Institutional Review Board of the AMC (IRB No. 2020-0297)

Keywords: COVID-19, SARS-CoV-2, Self-operating molecular diagnostics, Rapid diagnostics, Sample preparation, Virus enrichment

Suggested Citation

Jang, Yoon Ok and Kim, Nam Hun and Roh, Yeonjeong and Koo, Bonhan and Kim, Ji Yeun and Kim, Sung-Han and Shin, Yong, Self-Directed Molecular Diagnostics (SdMDx) System for COVID-19 via One-Pot Processing. Available at SSRN: https://ssrn.com/abstract=4213462 or http://dx.doi.org/10.2139/ssrn.4213462

Yoon Ok Jang

Yonsei University ( email )

Seoul
Korea, Republic of (South Korea)

Nam Hun Kim

INFUSIONTECH ( email )

Yeonjeong Roh

Yonsei University ( email )

Seoul
Korea, Republic of (South Korea)

Bonhan Koo

University of Ulsan - Asan Medical Center ( email )

Seoul
Korea, Republic of (South Korea)

Ji Yeun Kim

University of Ulsan ( email )

Sung-Han Kim

University of Ulsan ( email )

Yong Shin (Contact Author)

Yonsei University - Department of Biotechnology ( email )

50 Yonsei-ro
Seodaemun-gu
Seoul, 03722
Korea, Republic of (South Korea)
+82-2-3010-4193 (Phone)

University of Ulsan - Department of Convergence Medicine

Seoul
Korea, Republic of (South Korea)

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