BMJ Open (Nov 2020)
Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study
- Sophie Trouillet-Assant,
- Amélie Massardier-Pilonchery,
- Barbara Charbotel,
- Nicolas Guibert,
- Jean-Baptiste Fassier,
- Muriel Rabilloud,
- Chloe Albert Vega,
- Antonin Bal,
- Julie Anne Nazare,
- Pascal Fascia,
- Adèle Paul,
- Constance d Aubarede,
- Virginie Pitiot,
- Matthieu Lahousse,
- André Boibieux,
- Djamila Makhloufi,
- Chantal Simon,
- Mary Anne Trabaud,
- François Gueyffier,
- Jérôme Adnot,
- Dulce Alfaiate,
- Alain Bergeret,
- Florent Bonnet,
- Gaëlle Bourgeois,
- Florence Brunel-Dalmas,
- Eurydice Caire,
- Pierre Chiarello,
- Laurent Cotte,
- Constance d'Aubarede,
- François Durupt,
- Escuret Vanessa,
- Fascia Pascal,
- Fassier Jean-Baptiste,
- Fontaine Juliette,
- Gaillot-Durand Lucie,
- Gaymard Alexandre,
- Gillet Myriam,
- Godinot Matthieu,
- Gueyffier François,
- Guibert Nicolas,
- Josset Laurence,
- Lahousse Matthieu,
- Lina Bruno,
- Lozano Hélène,
- Makhloufi Djamila,
- Massardier-Pilonchéry Amélie,
- Milon Marie-Paule,
- Moll Frédéric,
- Morfin Florence,
- Narbey David,
- Nazare Julie-Anne,
- Oria Fatima,
- Paul Adèle,
- Perry Marielle,
- Pitiot Virginie,
- Prudent Mélanie,
- Rabilloud Muriel,
- Samperiz Audrey,
- Schlienger Isabelle,
- Simon Chantal,
- Trabaud Mary-Anne,
- Trouillet-Assant Sophie
Affiliations
- Sophie Trouillet-Assant
- Virpath - Université Lyon, CIRI, INSERM U1111, CNRS 5308, ENS, UCBL, Faculté de Médecine Lyon Est, Lyon, France
- Amélie Massardier-Pilonchery
- UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France
- Barbara Charbotel
- 1Université De Lyon, F-69003 Lyon, France; Université Lyon 1, UMRESTTE (Unité Mixte IFSTTAR/UCBL), Domaine Rockefeller, 69373 Lyon, France
- Nicolas Guibert
- UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France
- Jean-Baptiste Fassier
- UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France
- Muriel Rabilloud
- Université de Lyon; Université Lyon 1; Hospices Civils de Lyon, Pôle Santé Publique, Service de Biostatistique et Bioinformatique ; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Lyon, France
- Chloe Albert Vega
- Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France
- Antonin Bal
- Virpath - Université Lyon, CIRI, INSERM U1111, CNRS 5308, ENS, UCBL, Faculté de Médecine Lyon Est, Lyon, France
- Julie Anne Nazare
- CRNH Rhône-Alpes, University Lyon 1, Laboratoire CarMeN, Inserm U1060, INRA U1397, Pierre Benite, France
- Pascal Fascia
- Centre d’appui à la Prévention des Infections Associées aux Soins Auvergne - Rhône-Alpes, Hospices Civils de Lyon - Hôpital H Gabrielle, 20 route de Vourles, Saint Genis Laval, France
- Adèle Paul
- UMR T 9405, Univ Lyon, Univ Eiffel, Univ Lyon 1, IFSTTAR, UMRESTTE, Lyon, France
- Constance d Aubarede
- Service de médecine du travail et des pathologies professionnelles, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France
- Virginie Pitiot
- Plateforme Transversale de Recherche de l’IC-HCL, Hospices Civils de Lyon, Lyon, France
- Matthieu Lahousse
- Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France
- André Boibieux
- Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France
- Djamila Makhloufi
- Infectious and Tropical Diseases Unit, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France
- Chantal Simon
- CRNH Rhône-Alpes, University Lyon 1, Laboratoire CarMeN, Inserm U1060, INRA U1397, Pierre Benite, France
- Mary Anne Trabaud
- Laboratoire de Virologie, Institut des Agents Infectieux (IAI), Hospices Civils de Lyon, Groupement Hospitalier Nord, Lyon, France
- François Gueyffier
- UMR5558, Service des Données de Santé, Pôle de Santé Publique, Hospices Civils de Lyon, & Université de Lyon, Université Lyon 1, CNRS, Laboratoire de Biométrie et Biologie Evolutive, Villeurbanne, France
- Jérôme Adnot
- Dulce Alfaiate
- Alain Bergeret
- Occupational Health Department, University Hospital, Lyon, France
- Florent Bonnet
- Gaëlle Bourgeois
- Florence Brunel-Dalmas
- Eurydice Caire
- Pierre Chiarello
- Laurent Cotte
- 3 Department of Infectious Diseases, Hôpital de la Croix Rousse, INSERM U1052, Lyon, France
- Constance d'Aubarede
- François Durupt
- Escuret Vanessa
- Fascia Pascal
- Fassier Jean-Baptiste
- Fontaine Juliette
- Gaillot-Durand Lucie
- Gaymard Alexandre
- Gillet Myriam
- Godinot Matthieu
- Gueyffier François
- Guibert Nicolas
- Josset Laurence
- Lahousse Matthieu
- Lina Bruno
- Lozano Hélène
- Makhloufi Djamila
- Massardier-Pilonchéry Amélie
- Milon Marie-Paule
- Moll Frédéric
- Morfin Florence
- Narbey David
- Nazare Julie-Anne
- Oria Fatima
- Paul Adèle
- Perry Marielle
- Pitiot Virginie
- Prudent Mélanie
- Rabilloud Muriel
- Hospices Civils de Lyon, Lyon, France
- Samperiz Audrey
- Schlienger Isabelle
- Simon Chantal
- Trabaud Mary-Anne
- Trouillet-Assant Sophie
- DOI
- https://doi.org/10.1136/bmjopen-2020-041268
- Journal volume & issue
-
Vol. 10,
no. 11
Abstract
Introduction 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.Methods and analysis 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.Ethics and dissemination Ethical approval has been obtained from the national review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France) (ID RCB 2020-A00932-37). Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals.Trial registration number NCT04341142.