Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests
We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nada...
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| Veröffentlicht in: | PloS one 2021-02, Vol.16 (2), p.e0246536-e0246536 |
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| creator | Wakita, Mitsuru Idei, Mayumi Saito, Kaori Horiuchi, Yuki Yamatani, Kotoko Ishikawa, Suzuka Yamamoto, Takamasa Igawa, Gene Hinata, Masanobu Kadota, Katsuhiko Kurosawa, Taro Takahashi, Sho Saito, Takumi Misawa, Shigeki Akazawa, Chihiro Naito, Toshio Miida, Takashi Takahashi, Kazuhisa Ai, Tomohiko Tabe, Yoko |
| description | We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies. |
| doi_str_mv | 10.1371/journal.pone.0246536 |
| format | Article |
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We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0246536</identifier><identifier>PMID: 33556086</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Aged ; Antibodies ; Antibodies, Viral - immunology ; Antigens ; Biology and life sciences ; Coronaviridae ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 - immunology ; COVID-19 - virology ; COVID-19 Serological Testing - methods ; Data analysis ; Disease ; Editing ; Electrochemiluminescence ; Emergency medical services ; FDA approval ; Female ; Gastroenterology ; Glycoproteins ; Graduate schools ; Graduate studies ; Hematology ; Hospitals ; Humans ; Immune system ; Immunoassay ; Male ; Medical equipment ; Medical innovations ; Medical laboratories ; Medical technology ; Medicine ; Medicine and Health Sciences ; Membrane proteins ; Middle Aged ; Mutation ; Nucleocapsids ; Nucleotides ; Pandemics ; Physical Sciences ; Polymerase chain reaction ; Proteins ; Reagent Kits, Diagnostic ; Regulatory agencies ; Research and Analysis Methods ; Research facilities ; Respiratory diseases ; RNA viruses ; SARS-CoV-2 - physiology ; Sensitivity and Specificity ; Serology ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Spike glycoprotein ; Structural proteins ; Testing ; University faculty ; Viral diseases ; Viral envelope proteins ; Viruses</subject><ispartof>PloS one, 2021-02, Vol.16 (2), p.e0246536-e0246536</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Wakita 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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We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies</subject><subject>Antibodies, Viral - immunology</subject><subject>Antigens</subject><subject>Biology and life sciences</subject><subject>Coronaviridae</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - diagnosis</subject><subject>COVID-19 - immunology</subject><subject>COVID-19 - virology</subject><subject>COVID-19 Serological Testing - methods</subject><subject>Data analysis</subject><subject>Disease</subject><subject>Editing</subject><subject>Electrochemiluminescence</subject><subject>Emergency medical services</subject><subject>FDA approval</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Glycoproteins</subject><subject>Graduate schools</subject><subject>Graduate studies</subject><subject>Hematology</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Immune system</subject><subject>Immunoassay</subject><subject>Male</subject><subject>Medical equipment</subject><subject>Medical innovations</subject><subject>Medical laboratories</subject><subject>Medical technology</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Membrane proteins</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Nucleocapsids</subject><subject>Nucleotides</subject><subject>Pandemics</subject><subject>Physical Sciences</subject><subject>Polymerase chain reaction</subject><subject>Proteins</subject><subject>Reagent Kits, Diagnostic</subject><subject>Regulatory agencies</subject><subject>Research and Analysis Methods</subject><subject>Research facilities</subject><subject>Respiratory diseases</subject><subject>RNA viruses</subject><subject>SARS-CoV-2 - 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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>Wakita, Mitsuru</au><au>Idei, Mayumi</au><au>Saito, Kaori</au><au>Horiuchi, Yuki</au><au>Yamatani, Kotoko</au><au>Ishikawa, Suzuka</au><au>Yamamoto, Takamasa</au><au>Igawa, Gene</au><au>Hinata, Masanobu</au><au>Kadota, Katsuhiko</au><au>Kurosawa, Taro</au><au>Takahashi, Sho</au><au>Saito, Takumi</au><au>Misawa, Shigeki</au><au>Akazawa, Chihiro</au><au>Naito, Toshio</au><au>Miida, Takashi</au><au>Takahashi, Kazuhisa</au><au>Ai, Tomohiko</au><au>Tabe, Yoko</au><au>Roques, Pierre</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-02-08</date><risdate>2021</risdate><volume>16</volume><issue>2</issue><spage>e0246536</spage><epage>e0246536</epage><pages>e0246536-e0246536</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33556086</pmid><doi>10.1371/journal.pone.0246536</doi><tpages>e0246536</tpages><orcidid>https://orcid.org/0000-0003-0376-0227</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2021-02, Vol.16 (2), p.e0246536-e0246536 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2487424759 |
| 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 | Adult Aged Antibodies Antibodies, Viral - immunology Antigens Biology and life sciences Coronaviridae Coronaviruses COVID-19 COVID-19 - diagnosis COVID-19 - immunology COVID-19 - virology COVID-19 Serological Testing - methods Data analysis Disease Editing Electrochemiluminescence Emergency medical services FDA approval Female Gastroenterology Glycoproteins Graduate schools Graduate studies Hematology Hospitals Humans Immune system Immunoassay Male Medical equipment Medical innovations Medical laboratories Medical technology Medicine Medicine and Health Sciences Membrane proteins Middle Aged Mutation Nucleocapsids Nucleotides Pandemics Physical Sciences Polymerase chain reaction Proteins Reagent Kits, Diagnostic Regulatory agencies Research and Analysis Methods Research facilities Respiratory diseases RNA viruses SARS-CoV-2 - physiology Sensitivity and Specificity Serology Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Spike glycoprotein Structural proteins Testing University faculty Viral diseases Viral envelope proteins Viruses |
| title | Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests |
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