{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T11:14:05Z","timestamp":1790766845742,"version":"4.1.0"},"reference-count":11,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2020,11,24]],"date-time":"2020-11-24T00:00:00Z","timestamp":1606176000000},"content-version":"unspecified","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,9,24]]},"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The COVID-19 pandemic caused by SARS-CoV-2 threatens global public health, and there is an urgent public health need to assess acquired immunity to SARS-CoV-2. Serological tests might provide results that can be complementary to or confirm suspected COVID-19 cases and reveal previous infection. The performance of serological assays (sensitivity and specificity) has to be evaluated before their use in the general population. The neutralisation capacity of the produced antibodies also has to be evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We set up a prospective, multicentric clinical study to evaluate the performance of serological kits among a population of healthcare workers presenting mild symptoms suggestive of SARS-CoV-2 infection. Four hundred symptomatic healthcare workers will be included in the COVID-SER study. The values obtained from a control cohort included during the prepandemic time will be used as reference. A workflow was set up to study serological response to SARS-CoV-2 infection and to evaluate antibody neutralisation capacity in patients with a confirmed SARS-CoV-2 infection. The sensitivity and specificity of the tests will be assessed using molecular detection of the virus as a reference. The measurement of IgM and IgG antibodies will be performed once per week for 6 consecutive weeks and then at 6, 12, 18, 24 and 36 months after the diagnosis. The kinetics of IgM and IgG will determine the optimal period to perform serological testing. The proportion of false negative PCR tests in symptomatic subjects will be determined on the basis of subsequent seroconversions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been obtained from the national review board for biomedical research in April 2020 (Comit\u00e9 de Protection des Personnes Sud M\u00e9diterran\u00e9e I, Marseille, France) (ID RCB 2020-A00932-37). Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04341142\">NCT04341142<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-041268","type":"journal-article","created":{"date-parts":[[2020,11,24]],"date-time":"2020-11-24T18:16:55Z","timestamp":1606241815000},"page":"e041268","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct04341142","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Sophie","family":"Trouillet-Assant","sequence":"first","affiliation":[{"name":"Virpath - Universit\u00e9 Lyon, CIRI, INSERM U1111, CNRS 5308, ENS, UCBL, Facult\u00e9 de M\u00e9decine Lyon Est, Lyon, France"},{"name":"Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5914-3554","authenticated-orcid":false,"given":"Chloe","family":"Albert Vega","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonin","family":"Bal","sequence":"additional","affiliation":[{"name":"Virpath - Universit\u00e9 Lyon, CIRI, INSERM U1111, CNRS 5308, ENS, UCBL, Facult\u00e9 de M\u00e9decine Lyon Est, Lyon, France"},{"name":"Laboratoire de Virologie, Institut des Agents Infectieux (IAI), Hospices Civils de Lyon, Groupement Hospitalier Nord, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie Anne","family":"Nazare","sequence":"additional","affiliation":[{"name":"CRNH Rh\u00f4ne-Alpes, University Lyon 1, Laboratoire CarMeN, Inserm U1060, INRA U1397, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Fascia","sequence":"additional","affiliation":[{"name":"Centre d\u2019appui \u00e0 la Pr\u00e9vention des Infections Associ\u00e9es aux Soins Auvergne - Rh\u00f4ne-Alpes, Hospices Civils de Lyon - H\u00f4pital H Gabrielle, 20 route de Vourles, Saint Genis Laval, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ad\u00e8le","family":"Paul","sequence":"additional","affiliation":[{"name":"UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France"},{"name":"Service de m\u00e9decine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Am\u00e9lie","family":"Massardier-Pilonchery","sequence":"additional","affiliation":[{"name":"UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France"},{"name":"Service de m\u00e9decine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance","family":"d Aubarede","sequence":"additional","affiliation":[{"name":"Service de m\u00e9decine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Guibert","sequence":"additional","affiliation":[{"name":"UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France"},{"name":"Service de m\u00e9decine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginie","family":"Pitiot","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthieu","family":"Lahousse","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9","family":"Boibieux","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Djamila","family":"Makhloufi","sequence":"additional","affiliation":[{"name":"Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"Simon","sequence":"additional","affiliation":[{"name":"CRNH Rh\u00f4ne-Alpes, University Lyon 1, Laboratoire CarMeN, Inserm U1060, INRA U1397, Pierre Benite, France"},{"name":"Service d\u2019Endocrinologie, diab\u00e8te, nutrition, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muriel","family":"Rabilloud","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lyon; Universit\u00e9 Lyon 1; Hospices Civils de Lyon, P\u00f4le Sant\u00e9 Publique, Service de Biostatistique et Bioinformatique ; CNRS, UMR 5558, Laboratoire de Biom\u00e9trie et Biologie \u00c9volutive, \u00c9quipe Biostatistique-Sant\u00e9, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Anne","family":"Trabaud","sequence":"additional","affiliation":[{"name":"Laboratoire de Virologie, Institut des Agents Infectieux (IAI), Hospices Civils de Lyon, Groupement Hospitalier Nord, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Gueyffier","sequence":"additional","affiliation":[{"name":"UMR5558, Service des Donn\u00e9es de Sant\u00e9, P\u00f4le de Sant\u00e9 Publique, Hospices Civils de Lyon, & Universit\u00e9 de Lyon, Universit\u00e9 Lyon 1, CNRS, Laboratoire de Biom\u00e9trie et Biologie Evolutive, Villeurbanne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Baptiste","family":"Fassier","sequence":"additional","affiliation":[{"name":"UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France"},{"name":"Service de m\u00e9decine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2020,11,24]]},"reference":[{"key":"2025121511294888000_10.11.e041268.1","doi-asserted-by":"crossref","first-page":"758","DOI":"10.1016\/S1473-3099(20)30322-4","article-title":"The important role of serology for COVID-19 control","volume":"20","author":"Winter","year":"2020","journal-title":"Lancet Infect Dis"},{"key":"2025121511294888000_10.11.e041268.2","doi-asserted-by":"crossref","unstructured":"Wu F , Wang A , Liu M , et al . Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. medRxiv 2020.doi:10.2139\/ssrn.3566211","DOI":"10.2139\/ssrn.3566211"},{"key":"2025121511294888000_10.11.e041268.3","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.00879"},{"key":"2025121511294888000_10.11.e041268.4","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.8259"},{"key":"2025121511294888000_10.11.e041268.5","doi-asserted-by":"publisher","DOI":"10.1126\/science.abc1227"},{"key":"2025121511294888000_10.11.e041268.6","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.00512-20","article-title":"Laboratory diagnosis of COVID-19: current issues and challenges","volume":"58","author":"Tang","year":"2020","journal-title":"J Clin Microbiol"},{"key":"2025121511294888000_10.11.e041268.7","doi-asserted-by":"crossref","first-page":"1881","DOI":"10.1001\/jama.2020.6170","article-title":"The promise and peril of antibody testing for COVID-19","volume":"323","author":"Abbasi","year":"2020","journal-title":"JAMA"},{"key":"2025121511294888000_10.11.e041268.8","doi-asserted-by":"crossref","unstructured":"Amanat F , Stadlbauer D , Strohmeier S , et al . A serological assay to detect SARS-CoV-2 seroconversion in humans. medRxiv 2020:20037713.","DOI":"10.1101\/2020.03.17.20037713"},{"key":"2025121511294888000_10.11.e041268.9","doi-asserted-by":"publisher","DOI":"10.1136\/jclinpath-2020-206685"},{"key":"2025121511294888000_10.11.e041268.10","first-page":"13","article-title":"Diagnostic performance of COVID-19 serology assays","volume":"42","author":"Zainol Rashid","year":"2020","journal-title":"Malays J Pathol"},{"key":"2025121511294888000_10.11.e041268.11","article-title":"Antibody tests for identification of current and past infection with SARS-CoV-2","volume":"6","author":"Deeks","year":"2020","journal-title":"Cochrane Database Syst Rev"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-041268","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:29:52Z","timestamp":1765826992000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-041268"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11]]},"references-count":11,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2020,11,24]]},"published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1136\/bmjopen-2020-041268"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-041268","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11]]}}}