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RESEARCH ARTICLE
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Plant-produced recombinant SARS-CoV-2 receptor-binding domain; an economical, scalable biomaterial source for COVID-19 diagnosis

Kaewta Rattanapisit1 ,  Gorawit Yusakul2 ,  Balamurugan Shanmugaraj1 ,  Kittinop Kittirotruji1 ,  Phassorn Suwatsrisakul1 ,  Eakachai Prompetchara3,4 ,  Suthira Taychakhoonavud5*
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1 Baiya Phytopharm Co., Ltd., Bangkok, Thailand
2 School of Pharmacy, Walailak University, Nakhon Si Thammarat, Thailand
3 Centre of Excellence in Vaccine Research and Development (Chula Vaccine Research Centre, Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
4 Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
5 Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand
6 Research Unit for Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok, Thailand
7 Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand
BMT 2021 , 2(1), 43–49; https://doi.org/10.3877/cma.j.issn.2096-112X.2021.01.006
Submitted: 19 November 2020 | Revised: 12 March 2021 | Accepted: 17 March 2021 | Published: 28 March 2021
Copyright © 2021 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution–NonCommercial–ShareAlike 4.0 License.
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Abstract

The outbreak of the novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread rapidly causing a severe global health burden. The standard COVID-19 diagnosis relies heavily on molecular tests to detect viral RNA in patient samples; however, this method is costly, requires highly-equipped laboratories, multiple reagents, skilled laboratory technicians, and takes 3-6 hours to complete. To overcome these limitations, we developed a plant-based production platform for the SARS-CoV-2 receptor-binding domain as an economical source of detection reagents for a lateral-flow immunoassay strip (LFIA) which is suitable for detection of IgM/IgG antibodies in human samples. Further, we validated the plant-produced SARS-CoV-2 receptor-binding domain-based LFIA as a useful diagnostic tool for COVID-19. A total of 51 confirmed COVID-19 serum samples were tested using the LFIA, and the obtained results were consistent with those from polymerase chain reaction assays, while providing sensitivity and specificity of 94.1% and 98%, respectively. The developed LFIA is rapid, scalable, user-friendly, and relatively inexpensive with a simple test procedure, making it useful for the routine monitoring of COVID-19 in clinical settings. This study was approved on March 19, 2020 by the Ethics Committee of the Faculty of Medicine, Chulalongkorn University (COA No. 354/2020 and IRB No. 236/63).

Keywords
COVID-19
lateral flow immunoassay
Nicotiana benthamiana
point-of-care testing
recombinant protein
SARS-CoV-2
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Conflict of interest
The authors declare they have no competing interests.
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