Performance evaluation of the Ortho VITROS SARS-CoV-2 Spike-Specific Quantitative IgG test by comparison with the surrogate virus neutralizing antibody test and clinical assessment
Despite the worldwide campaigns of COVID-19 vaccinations, the pandemic is still a major medical and social problem. The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodie...
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| Veröffentlicht in: | PloS one 2023-01, Vol.18 (1), p.e0279779-e0279779 |
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| creator | Takahashi, Maika Saito, Kaori Ai, Tomohiko Nojiri, Shuko Khasawneh, Abdullah Paran, Faith Jessica Horiuchi, Yuki Takei, Satomi Yamamoto, Takamasa Wakita, Mitsuru Hiki, Makoto Miida, Takashi Naito, Toshio Takahashi, Kazuhisa Tabe, Yoko |
| description | Despite the worldwide campaigns of COVID-19 vaccinations, the pandemic is still a major medical and social problem. The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodies. However, it has not been evaluated in Japan, where the total cases and death toll are lower than the rest of the world.
The clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine.
VITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19.
Although the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results. |
| doi_str_mv | 10.1371/journal.pone.0279779 |
| format | Article |
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The clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine.
VITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19.
Although the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0279779</identifier><identifier>PMID: 36693058</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Antibodies ; Antibodies, Blocking ; Antibodies, Neutralizing ; Antibodies, Viral ; Antigens ; Biology and Life Sciences ; Blood Group Antigens ; BNT162 Vaccine ; Coronaviruses ; Correlation ; COVID-19 ; COVID-19 Testing ; COVID-19 vaccines ; Enzymes ; Fatalities ; Health aspects ; Herd immunity ; Humans ; Immune response (humoral) ; Immunization ; Immunoassay ; Immunoglobulin G ; Infections ; Kruskal-Wallis test ; Medical personnel ; Medicine and Health Sciences ; Neutralizing ; Nucleocapsids ; Pandemics ; People and Places ; Performance evaluation ; Pneumonia ; Proteins ; Reagents ; Research and Analysis Methods ; SARS-CoV-2 ; Serology ; Severe acute respiratory syndrome coronavirus 2 ; Vaccines ; Variance analysis ; Viral antibodies ; Viral diseases ; Viruses</subject><ispartof>PloS one, 2023-01, Vol.18 (1), p.e0279779-e0279779</ispartof><rights>Copyright: © 2023 Takahashi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2023 Public Library of Science</rights><rights>2023 Takahashi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 Takahashi et al 2023 Takahashi et al</rights><rights>2023 Takahashi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodies. However, it has not been evaluated in Japan, where the total cases and death toll are lower than the rest of the world.
The clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine.
VITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19.
Although the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results.</description><subject>Antibodies</subject><subject>Antibodies, Blocking</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>Antigens</subject><subject>Biology and Life Sciences</subject><subject>Blood Group Antigens</subject><subject>BNT162 Vaccine</subject><subject>Coronaviruses</subject><subject>Correlation</subject><subject>COVID-19</subject><subject>COVID-19 Testing</subject><subject>COVID-19 vaccines</subject><subject>Enzymes</subject><subject>Fatalities</subject><subject>Health aspects</subject><subject>Herd immunity</subject><subject>Humans</subject><subject>Immune response (humoral)</subject><subject>Immunization</subject><subject>Immunoassay</subject><subject>Immunoglobulin G</subject><subject>Infections</subject><subject>Kruskal-Wallis test</subject><subject>Medical personnel</subject><subject>Medicine and Health 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Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Takahashi, Maika</au><au>Saito, Kaori</au><au>Ai, Tomohiko</au><au>Nojiri, Shuko</au><au>Khasawneh, Abdullah</au><au>Paran, Faith Jessica</au><au>Horiuchi, Yuki</au><au>Takei, Satomi</au><au>Yamamoto, Takamasa</au><au>Wakita, Mitsuru</au><au>Hiki, Makoto</au><au>Miida, Takashi</au><au>Naito, Toshio</au><au>Takahashi, Kazuhisa</au><au>Tabe, Yoko</au><au>Ito, Etsuro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Performance evaluation of the Ortho VITROS SARS-CoV-2 Spike-Specific Quantitative IgG test by comparison with the surrogate virus neutralizing antibody test and clinical assessment</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2023-01-24</date><risdate>2023</risdate><volume>18</volume><issue>1</issue><spage>e0279779</spage><epage>e0279779</epage><pages>e0279779-e0279779</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Despite the worldwide campaigns of COVID-19 vaccinations, the pandemic is still a major medical and social problem. The Ortho VITROS SARS-CoV-2 spike-specific quantitative IgG (VITROS S-IgG) assay has been developed to assess neutralizing antibody (NT antibody) against SARS-CoV-2 spike (S) antibodies. However, it has not been evaluated in Japan, where the total cases and death toll are lower than the rest of the world.
The clinical performance of VITROS S-IgG was evaluated by comparing with the NT antibody levels measured by the surrogate virus neutralizing antibody test (sVNT). A total of 332 serum samples from 188 individuals were used. Of these, 219 samples were from 75 COVID-19 patients: 96 samples from 20 severe/critical cases (Group S), and 123 samples from 55 mild/moderate cases (Group M). The remaining 113 samples were from 113 healthcare workers who had received 2 doses of the BNT162b2 vaccine.
VITROS S-IgG showed good correlation with the cPass sVNT assay (Spearman rho = 0.91). Both VITROS S-IgG and cPass sVNT showed significantly higher plateau levels of antibodies in Group S compared to Group M. Regarding the humoral immune responses after BNT162b2 vaccination, individuals who were negative for SARS-CoV-2 nucleocapsid (N)-specific antibodies had statistically lower titers of both S-IgG and sVNT compared to individuals with a history of COVID-19 and individuals who were positive for N-specific antibodies without history of COVID-19. In individuals who were positive for N-specific antibodies, S-IgG and sVNT titers were similar to individuals with a history of COVID-19.
Although the automated quantitative immunoassay VITROS S-IgG showed a reasonable correlation with sVNT antibodies, there is some discrepancy between Vitros S-IgG and cPass sVNT in milder cases. Thus, VITROS S-IgG can be a useful diagnostic tool in assessing the immune responses to vaccination and herd immunity. However, careful analysis is necessary to interpret the results.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>36693058</pmid><doi>10.1371/journal.pone.0279779</doi><tpages>e0279779</tpages><orcidid>https://orcid.org/0000-0003-1646-9930</orcidid><orcidid>https://orcid.org/0000-0003-1149-5048</orcidid><orcidid>https://orcid.org/0000-0002-4294-8030</orcidid><orcidid>https://orcid.org/0000-0002-8324-4048</orcidid><orcidid>https://orcid.org/0000-0002-3734-0346</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2023-01, Vol.18 (1), p.e0279779-e0279779 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2769175430 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Antibodies Antibodies, Blocking Antibodies, Neutralizing Antibodies, Viral Antigens Biology and Life Sciences Blood Group Antigens BNT162 Vaccine Coronaviruses Correlation COVID-19 COVID-19 Testing COVID-19 vaccines Enzymes Fatalities Health aspects Herd immunity Humans Immune response (humoral) Immunization Immunoassay Immunoglobulin G Infections Kruskal-Wallis test Medical personnel Medicine and Health Sciences Neutralizing Nucleocapsids Pandemics People and Places Performance evaluation Pneumonia Proteins Reagents Research and Analysis Methods SARS-CoV-2 Serology Severe acute respiratory syndrome coronavirus 2 Vaccines Variance analysis Viral antibodies Viral diseases Viruses |
| title | Performance evaluation of the Ortho VITROS SARS-CoV-2 Spike-Specific Quantitative IgG test by comparison with the surrogate virus neutralizing antibody test and clinical assessment |
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