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 re...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).展开更多
基金This study was funded by Baiya Phytopharm Co.,Ltd.
文摘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).
