Accurate point-of-care serology tests for COVID-19
As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if...
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| Veröffentlicht in: | PloS one 2021-03, Vol.16 (3), p.e0248729-e0248729 |
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| creator | Schuler, 4th, Charles F Gherasim, Carmen O'Shea, Kelly Manthei, David M Chen, Jesse Giacherio, Don Troost, Jonathan P Baldwin, James L Baker, Jr, James R |
| description | As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection.
Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated.
512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity.
Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response. |
| doi_str_mv | 10.1371/journal.pone.0248729 |
| format | Article |
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Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated.
512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity.
Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0248729</identifier><identifier>PMID: 33725025</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Aged ; Antibodies ; Antibodies, Viral - blood ; Biology and Life Sciences ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 - virology ; COVID-19 diagnostic tests ; COVID-19 Serological Testing ; Data analysis ; Diagnosis ; Drafting software ; Editing ; Engineering and Technology ; Epidemics ; Female ; Food allergies ; Food hypersensitivity ; Funding ; Genetic aspects ; Humans ; Immunoassay ; Immunoglobulin G - blood ; Immunoglobulin M - blood ; Immunology ; Infections ; Internal medicine ; Laboratories ; Male ; Medical personnel ; Medicine ; Medicine and Health Sciences ; Methodology ; Middle Aged ; Nanotechnology ; Nucleocapsid - immunology ; Pandemics ; Pathology ; Point-of-Care Systems ; Polymerase chain reaction ; Reagent Kits, Diagnostic ; Research and Analysis Methods ; SARS-CoV-2 - immunology ; SARS-CoV-2 - isolation & purification ; Sensitivity and Specificity ; Serodiagnosis ; Serology ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Software ; Supervision ; United States ; Vaccines ; Viral diseases ; Visualization ; Young Adult</subject><ispartof>PloS one, 2021-03, Vol.16 (3), p.e0248729-e0248729</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Schuler 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>2021 Schuler et al 2021 Schuler et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-4e71c694feff9380681d21055e9e7b0a839a62d2c40206cb61f0e5dbd92895ba3</citedby><cites>FETCH-LOGICAL-c692t-4e71c694feff9380681d21055e9e7b0a839a62d2c40206cb61f0e5dbd92895ba3</cites><orcidid>0000-0001-5656-7418 ; 0000-0002-1183-8330</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7963097/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7963097/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33725025$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Ley, Benedikt</contributor><creatorcontrib>Schuler, 4th, Charles F</creatorcontrib><creatorcontrib>Gherasim, Carmen</creatorcontrib><creatorcontrib>O'Shea, Kelly</creatorcontrib><creatorcontrib>Manthei, David M</creatorcontrib><creatorcontrib>Chen, Jesse</creatorcontrib><creatorcontrib>Giacherio, Don</creatorcontrib><creatorcontrib>Troost, Jonathan P</creatorcontrib><creatorcontrib>Baldwin, James L</creatorcontrib><creatorcontrib>Baker, Jr, James R</creatorcontrib><title>Accurate point-of-care serology tests for COVID-19</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection.
Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated.
512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity.
Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. 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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>Schuler, 4th, Charles F</au><au>Gherasim, Carmen</au><au>O'Shea, Kelly</au><au>Manthei, David M</au><au>Chen, Jesse</au><au>Giacherio, Don</au><au>Troost, Jonathan P</au><au>Baldwin, James L</au><au>Baker, Jr, James R</au><au>Ley, Benedikt</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Accurate point-of-care serology tests for COVID-19</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-03-16</date><risdate>2021</risdate><volume>16</volume><issue>3</issue><spage>e0248729</spage><epage>e0248729</epage><pages>e0248729-e0248729</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection.
Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated.
512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity.
Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33725025</pmid><doi>10.1371/journal.pone.0248729</doi><tpages>e0248729</tpages><orcidid>https://orcid.org/0000-0001-5656-7418</orcidid><orcidid>https://orcid.org/0000-0002-1183-8330</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2021-03, Vol.16 (3), p.e0248729-e0248729 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2501837420 |
| source | MEDLINE; Public Library of Science; DOAJ Directory of Open Access Journals; PubMed Central; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Adult Aged Antibodies Antibodies, Viral - blood Biology and Life Sciences Coronaviruses COVID-19 COVID-19 - diagnosis COVID-19 - virology COVID-19 diagnostic tests COVID-19 Serological Testing Data analysis Diagnosis Drafting software Editing Engineering and Technology Epidemics Female Food allergies Food hypersensitivity Funding Genetic aspects Humans Immunoassay Immunoglobulin G - blood Immunoglobulin M - blood Immunology Infections Internal medicine Laboratories Male Medical personnel Medicine Medicine and Health Sciences Methodology Middle Aged Nanotechnology Nucleocapsid - immunology Pandemics Pathology Point-of-Care Systems Polymerase chain reaction Reagent Kits, Diagnostic Research and Analysis Methods SARS-CoV-2 - immunology SARS-CoV-2 - isolation & purification Sensitivity and Specificity Serodiagnosis Serology Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Software Supervision United States Vaccines Viral diseases Visualization Young Adult |
| title | Accurate point-of-care serology tests for COVID-19 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-03T18%3A18%3A40IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Accurate%20point-of-care%20serology%20tests%20for%20COVID-19&rft.jtitle=PloS%20one&rft.au=Schuler,%204th,%20Charles%20F&rft.date=2021-03-16&rft.volume=16&rft.issue=3&rft.spage=e0248729&rft.epage=e0248729&rft.pages=e0248729-e0248729&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0248729&rft_dat=%3Cgale_plos_%3EA655200146%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2501837420&rft_id=info:pmid/33725025&rft_galeid=A655200146&rft_doaj_id=oai_doaj_org_article_96e8a5c980564ecf91b92c95ba97a12b&rfr_iscdi=true |