tetano
Editor, Senior Moderator
J Virol Methods
. 2021 May 10;114183.
doi: 10.1016/j.jviromet.2021.114183. Online ahead of print.
Development of an immunochromatographic kit to detect severe acute respiratory syndrome coronavirus 2
Satoshi Oshiro[SUP] 1 [/SUP], Yoko Tabe[SUP] 2 [/SUP], Keiji Funatogawa[SUP] 3 [/SUP], Kaori Saito[SUP] 2 [/SUP], Tatsuya Tada[SUP] 1 [/SUP], Tomomi Hishinuma[SUP] 1 [/SUP], Naeko Mizutani[SUP] 1 [/SUP], Makoto Akiwa[SUP] 4 [/SUP], Jun-Ichiro Sekiguchi[SUP] 4 [/SUP], Takashi Miida[SUP] 2 [/SUP], Teruo Kirikae[SUP] 5 [/SUP]
Affiliations
Abstract
Background: The novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for the worldwide coronavirus disease-19 (COVID-19) pandemic, starting in late 2019. The standard diagnostic methods to detect SARS-CoV-2 are PCR-based genetic assays. Antigen-antibody-based immunochromatographic assays are alternative methods of detecting this virus. Rapid diagnosis kits to detect SARS-CoV-2 are urgently needed.
Study design: Three monoclonal antibodies against SARS-CoV-2 nucleocapsid (N) protein were used to develop an antigen-antibody-based immunochromatographic kit to detect SARS-CoV-2. These assays were evaluated using nasopharyngeal swab specimens collected from patients suspected of having COVID-19.
Results: These assays detected recombinant SARS-CoV-2 N protein at concentrations >0.2 ng/ml within 10 minutes after protein loading, but did not detect the N proteins of Middle East respiratory syndrome coronavirus (MERS-CoV), human coronaviruses OC43 (HCoV-OC43) and 299E (HCoV-229E) and other pathogens causing respiratory infections. Nasopharyngeal swab specimens obtained 1?3, 4?9, and ? 10 days after symptom onset from COVID-19 patients diagnosed by RT-PCR showed positivity rates of 100%, >80%, and <30%, respectively.
Conclusions: Kits using this immunochromatographic assay may be a rapid and useful tool for point-of-care diagnosis of COVID-19 when samples are obtained from patients 1?9 days after symptom onset.
Keywords: Immunochromatographic kit; coronavirus disease-19 (COVID-19); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
. 2021 May 10;114183.
doi: 10.1016/j.jviromet.2021.114183. Online ahead of print.
Development of an immunochromatographic kit to detect severe acute respiratory syndrome coronavirus 2
Satoshi Oshiro[SUP] 1 [/SUP], Yoko Tabe[SUP] 2 [/SUP], Keiji Funatogawa[SUP] 3 [/SUP], Kaori Saito[SUP] 2 [/SUP], Tatsuya Tada[SUP] 1 [/SUP], Tomomi Hishinuma[SUP] 1 [/SUP], Naeko Mizutani[SUP] 1 [/SUP], Makoto Akiwa[SUP] 4 [/SUP], Jun-Ichiro Sekiguchi[SUP] 4 [/SUP], Takashi Miida[SUP] 2 [/SUP], Teruo Kirikae[SUP] 5 [/SUP]
Affiliations
- PMID: 33984393
- PMCID: PMC8110331
- DOI: 10.1016/j.jviromet.2021.114183
Abstract
Background: The novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for the worldwide coronavirus disease-19 (COVID-19) pandemic, starting in late 2019. The standard diagnostic methods to detect SARS-CoV-2 are PCR-based genetic assays. Antigen-antibody-based immunochromatographic assays are alternative methods of detecting this virus. Rapid diagnosis kits to detect SARS-CoV-2 are urgently needed.
Study design: Three monoclonal antibodies against SARS-CoV-2 nucleocapsid (N) protein were used to develop an antigen-antibody-based immunochromatographic kit to detect SARS-CoV-2. These assays were evaluated using nasopharyngeal swab specimens collected from patients suspected of having COVID-19.
Results: These assays detected recombinant SARS-CoV-2 N protein at concentrations >0.2 ng/ml within 10 minutes after protein loading, but did not detect the N proteins of Middle East respiratory syndrome coronavirus (MERS-CoV), human coronaviruses OC43 (HCoV-OC43) and 299E (HCoV-229E) and other pathogens causing respiratory infections. Nasopharyngeal swab specimens obtained 1?3, 4?9, and ? 10 days after symptom onset from COVID-19 patients diagnosed by RT-PCR showed positivity rates of 100%, >80%, and <30%, respectively.
Conclusions: Kits using this immunochromatographic assay may be a rapid and useful tool for point-of-care diagnosis of COVID-19 when samples are obtained from patients 1?9 days after symptom onset.
Keywords: Immunochromatographic kit; coronavirus disease-19 (COVID-19); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).