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1. Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study

Author

Antonin Bal, Karen Brengel-Pesce, Alexandre Gaymard, Grégory Quéromès, Nicolas Guibert, Emile Frobert, Maude Bouscambert, Mary-Anne Trabaud, Florence Allantaz-Frager, Guy Oriol, Valérie Cheynet, Constance d’Aubarede, Amélie Massardier-Pilonchery, Marlyse Buisson, Julien Lupo, Bruno Pozzetto, Pascal Poignard, Bruno Lina, Jean-Baptiste Fassier, Florence Morfin, Sophie Trouillet-Assant, and COVID-SER Study group

Subjects
Medicine, Science
Abstract

Abstract A comprehensive clinical and microbiological assessments of COVID-19 in front-line healthcare workers (HCWs) is needed. Between April 10th and May 28th, 2020, 319 HCWs with acute illness were reviewed. In addition to SARS-CoV-2 RT-PCR screening, a multiplex molecular panel was used for testing other respiratory pathogens. For SARS-CoV-2 positive HCWs, the normalized viral load, viral culture, and virus neutralization assays were performed weekly. For SARS-CoV-2 negative HCWs, SARS-CoV-2 serological testing was performed one month after inclusion. Among the 319 HCWs included, 67 (21.0%) were tested positive for SARS-CoV-2; 65/67 (97.0%) developed mild form of COVID-19. Other respiratory pathogens were found in 6/66 (9.1%) SARS-CoV-2 positive and 47/241 (19.5%) SARS-Cov-2 negative HCWs (p = 0.07). The proportion of HCWs with a viral load > 5.0 log10 cp/mL (Ct value 37). More than 90% of cultivable virus had a viral load > 4.5 log10 cp/mL (Ct

Published
2021
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2. Publisher Correction: Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study

Author

Antonin Bal, Karen Brengel-Pesce, Alexandre Gaymard, Grégory Quéromès, Nicolas Guibert, Emilie Frobert, Maude Bouscambert, Mary-Anne Trabaud, Florence Allantaz-Frager, Guy Oriol, Valérie Cheynet, Constance d’Aubarede, Amélie Massardier-Pilonchery, Marlyse Buisson, Julien Lupo, Bruno Pozzetto, Pascal Poignard, Bruno Lina, Jean-Baptiste Fassier, Florence Morfin, Sophie Trouillet-Assant, and COVID-SER Study group

Subjects
Medicine, Science
Published
2021
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3. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study

Author

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, and Trouillet-Assant Sophie

Subjects
Medicine
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.

Published
2020
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4. Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study

Author

Nicolas Guibert, Jean-Baptiste Fassier, Guy Oriol, M. Bouscambert, Florence Allantaz-Frager, Valérie Cheynet, Emilie Frobert, Pascal Poignard, Julien Lupo, Marlyse Buisson, Bruno Lina, Constance d’Aubarede, Alexandre Gaymard, Bruno Pozzetto, Antonin Bal, Karen Brengel-Pesce, Mary-Anne Trabaud, Grégory Quéromès, Sophie Trouillet-Assant, Amélie Massardier-Pilonchery, Florence Morfin, Unité Mixte de Recherche Epidémiologique et de Surveillance Transport Travail Environnement (UMRESTTE UMR_T9405), Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Université Gustave Eiffel

Subjects
0301 basic medicine, Male, COVID19, health care facilities, manpower, and services, viruses, ADOLESCENT, Serology, 0302 clinical medicine, Health care, 030212 general & internal medicine, Prospective Studies, Young adult, Prospective cohort study, skin and connective tissue diseases, Aged, 80 and over, Multidisciplinary, Viral culture, virus diseases, Middle Aged, Viral Load, 3. Good health, COVID-19 Nucleic Acid Testing, Medicine, Female, Viral load, Adult, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), MALADIE, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Health Personnel, Science, 030106 microbiology, education, 80 AND OVER, Microbiology, Article, COVID-19 Serological Testing, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Humans, ADULTE, Aged, business.industry, SARS-CoV-2, COVID-19, business, SOCIOLOGIE, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

A comprehensive clinical and microbiological assessments of COVID-19 in front-line healthcare workers (HCWs) is needed. Between April 10th and May 28th, 2020, 319 HCWs with acute illness were reviewed. In addition to SARS-CoV-2 RT-PCR screening, a multiplex molecular panel was used for testing other respiratory pathogens. For SARS-CoV-2 positive HCWs, the normalized viral load, viral culture, and virus neutralization assays were performed weekly. For SARS-CoV-2 negative HCWs, SARS-CoV-2 serological testing was performed one month after inclusion. Among the 319 HCWs included, 67 (21.0%) were tested positive for SARS-CoV-2; 65/67 (97.0%) developed mild form of COVID-19. Other respiratory pathogens were found in 6/66 (9.1%) SARS-CoV-2 positive and 47/241 (19.5%) SARS-Cov-2 negative HCWs (p = 0.07). The proportion of HCWs with a viral load > 5.0 log10 cp/mL (Ct value 37). More than 90% of cultivable virus had a viral load > 4.5 log10 cp/mL (Ct

Published
2021
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5. Six-month antibody response to SARS-CoV-2 in healthcare workers assessed by virus neutralization and commercial assays

Author

Fascia Pascal, Adnot Jérôme, Fontaine Juliette, Massardier-Pilonchéry Amélie, Boibieux André, Josset Laurence, Nicolas Guibert, Oria Fatima, Nazare Julie-Anne, Chiarello Pierre, Samperiz Audrey, Antonin Bal, Prudent Mélanie, Simon Chantal, Dulce Alfaiate, Fassier Jean-Baptiste, Florence Morfin-Sherpa, Constance d'Aubarede, Brunel-Dalmas Florence, Lahousse Matthieu, Pitiot Virginie, Trabaud Mary-Anne, Gaillot-Durand Lucie, Bal Antonin, Lina Bruno, Trouillet-Assant Sophie, Gueyffier François, Perry Marielle, Gillet Myriam, Adèle Paul, Jean-Baptiste Fassier, Valette Martine, Bourgeois Gaëlle, Lozano Hélène, Kahina Saker, Alfaiate Dulce, Morfin Florence, Mary-Anne Trabaud, Rabilloud Muriel, Schlienger Isabelle, Narbey David, Durupt François, Makhloufi Djamila, Bruno Pozzetto, Paul Adèle, Caire Eurydice, Bergeret Alain, Godinot Matthieu, Escuret Vanessa, Bonnet Florent, Moll Frédéric, Guibert Nicolas, Gaymard Alexandre, Cotte Laurent, Sophie Trouillet-Assant, Muriel Rabilloud, Virginie Pitiot, Amélie Massardier-Pilonchery, Milon Marie-Paule, Charbotel Barbara, Carole Langlois-Jacques, Bruno Lina, Hospices Civils de Lyon (HCL), Unité Mixte de Recherche Epidémiologique et de Surveillance Transport Travail Environnement (UMRESTTE UMR_T9405), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Gustave Eiffel, Université de Lyon, Institut des Agents Infectieux [Lyon] (IAI), Service de médecine et santé au travail, hospices civils de Lyon, Laboratoire de virologie, Physiopathologie et biothérapies des infections muqueuses (GIMAP), Centre International de Recherche en Infectiologie - UMR (CIRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Université Jean Monnet [Saint-Étienne] (UJM), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Jean Monnet [Saint-Étienne] (UJM)

Subjects
Male, Time Factors, Antibodies, Viral, Neutralization, MEDECINE, Health personnel, 0302 clinical medicine, SANTE, SARS-COV2, Medicine, 030212 general & internal medicine, Letter to the Editor, 0303 health sciences, biology, PERSONNEL DE SANTE, virus diseases, General Medicine, Middle Aged, University hospital, TRAVAIL, 3. Good health, Titer, Infectious Diseases, Female, Antibody, Serological assays, ANTICORPS, Adult, Microbiology (medical), 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Health Personnel, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), education, GESTION DU PERSONNEL, Virus Neutralization, Virus, 03 medical and health sciences, Neutralization Tests, Seroprevalence, Humans, Healthcare workers, Virus neutralisation assay, 030304 developmental biology, SARS-CoV-2, business.industry, COVID-19, Antibodies, Neutralizing, Virology, Antibody response, biology.protein, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

We conducted a prospective study in healthcare workers (n=296) of the University Hospital of Lyon, France. Serum samples (n=296) collected six months after disease onset were tested using three commercial assays: the Wantai Ab assay detecting total antibodies against the receptor binding domain (RBD) of the S protein, the bioMerieux Vidas assay detecting IgG to the RBD and the Abbott Architect assay detecting IgG to the N protein. The neutralising antibody (NAb) titre was also determined for all samples with a virus neutralisation assay (VNA) using live virus. The positivity rate was 100% with the Wantai assay, 84.8% with the bioMerieux assay and 55.4% with the Abbott assay. Only 51% of HCWs were positive for the presence of NAb. Less than 10 % of HCWs had a NAb titre greater than 80. At a neutralising titre of 80, the area under the curves [IC 95%] was 0.71 [0.62-0.81], 0.75 [0.65-0.85] and 0.95 [0.92-0.97] for Wantai, Abbott and Vidas respectively. The data presented herein suggest that commercial assays detecting antibodies against the N protein must not be used in long-term seroprevalence surveys while the Wantai assay could be useful for this purpose. VNA should remain the gold standard to assess the protective antibody response, but some commercial assays could be used as first-line screening of long-term presence of NAb.

Published
2021
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6. Publisher Correction: Clinical and laboratory characteristics of symptomatic healthcare workers with suspected COVID-19: a prospective cohort study

Author

Bruno Lina, Pascal Poignard, Julien Lupo, Florence Allantaz-Frager, Amélie Massardier-Pilonchery, Alexandre Gaymard, Bruno Pozzetto, M. Bouscambert, Jean-Baptiste Fassier, Valérie Cheynet, Marlyse Buisson, Constance d’Aubarede, Guy Oriol, Florence Morfin, Emilie Frobert, Nicolas Guibert, Sophie Trouillet-Assant, Antonin Bal, Karen Brengel-Pesce, Mary-Anne Trabaud, and Grégory Quéromès

Subjects
medicine.medical_specialty, 2019-20 coronavirus outbreak, Multidisciplinary, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Science, MEDLINE, Publisher Correction, Emergency medicine, Health care, medicine, Medicine, business, Prospective cohort study
Published
2021

7. Two-step strategy for the identification of SARS-CoV-2 variant of concern 202012/01 and other variants with spike deletion H69-V70, France, August to December 2020

Author

Geneviève Billaud, Bruno Lina, Florence Morfin, Alexandre Gaymard, M. Bouscambert, Constance d'Aubarede, Quentin Semanas, M. Valette, Frédéric Laurent, Grégory Destras, Laurence Josset, Claudia González, Antonin Bal, and Hadrien Regue

Subjects
Whole genome sequencing, Genetics, Co occurring, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Two step, Spike (software development), Biology, False Negative Result
Abstract

We report the implementation of a two-step strategy for the identification of SARS-CoV-2 variants carrying the spike deletion H69-V70 (ΔH69/ΔV70). This spike deletion resulted in a S-gene target failure (SGTF) of a three-target RT-PCR assay (TaqPath kit). Whole genome sequencing performed on 37 samples with SGTF revealed several receptor-binding domain mutations co-occurring with ΔH69/ΔV70. More importantly, this strategy enabled the first detection of the variant of concern 202012/01 in France on December 21th 2020.Since September a SARS-CoV-2 spike (S) deletion H69-V70 (ΔH69/ΔV70) has attracted increasing attention. This deletion was detected in the cluster-5 variant identified both in minks and humans in Denmark. This cluster-5 variant carries a receptor binding domain (RBD) mutation Y453F and was associated with reduced susceptibility to neutralizing antibodies to sera from recovered COVID-19 patients [1–3]. The ΔH69/ΔV70 has also co-occurred with two other RBD mutations of increasing interest [4]: N439K that is currently spreading in Europe and might also have reduced susceptibility to SARS-CoV-2 antibodies [5]; and N501Y that is part of the SARS-CoV-2 variant of concern (VOC) 202012/01 recently detected in England [6]. Although the impact of ΔH69/ΔV70 on SARS-CoV-2 pathogenesis is not clear, enhanced surveillance is urgently needed. Herein we report the implementation of a two-step strategy enabling a rapid detection of VOC 202012/01 or other variants carrying ΔH69/ΔV70.

Published
2020
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8. Evaluation of high-throughput SARS-CoV-2 serological assays in a longitudinal cohort of mild COVID-19 patients: sensitivity, specificity and association with virus neutralization test

Author

François Gueyffier, Jean Baptiste Fassier, Mary-Anne Trabaud, Constance d’Aubarede, Antonin Bal, Muriel Rabilloud, Sophie Assant, Bruno Pozzetto, David Goncalves, Nicolas Guibert, Carole Langlois-Jacques, Adèle Paul, Virginie Pitiot, Amelie Massardier, F. Morfin, Vanessa Escuret, Bruno Lina, Andre Boibieux, and Nicole Fabien

Subjects
biology, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Concordance, Virology, Serology, Titer, biology.protein, Medicine, Antibody, business, Neutralizing antibody, Kappa
Abstract

ObjectivesWe evaluated widely-used SARS-CoV-2 serological tests and their potential association with virus neutralization test (VNT) in a cohort of mild COVID-19 patients.MethodsA total of 439 specimens were longitudinally collected from 76 healthcare workers with RT-PCR-confirmed mild COVID-19. Nine serological assays developed by leading global companies (Abbott, DiaSorin, Siemens, Bio-Rad, Wantai, bioMérieux, Euroimmun) were assessed. For each test the sensitivity to detect SARS-CoV-2 antibodies was determined weekly after symptom onset. Correlation and concordance were assessed using the Spearman and Cohen’s Kappa coefficients, respectively. Positive percent agreement and negative percent agreement (NPA) with the VNT were also determined.ResultsThe Wantai Total Ab assay targeting the receptor binding domain (RBD) within the S protein presented the best sensitivity at different times during the course of disease. The best correlation between antibody level and neutralizing antibody titer was found with the Euroimmun S1-based IgA assay (Spearman coefficient [95%CI]: 0.71 [0.61-0.79]). A moderate concordance (Kappa [95%CI]: 0.43[0.23-0.63]) as well as the lowest NPA (33%) was found between the Wantai Total Ab assay and the VNT. Compared to the Wantai Total Ab assay, other total Ab or IgG assays targeting the S or the RBD (bioMérieux, DiaSorin, Siemens,) were more concordant with the VNT (Kappa>0.7 for the three tests) and had a higher NPA (range: 90% to 97%).ConclusionsAlthough some assays presented a better concordance with VNT than others, the present findings emphasize that commercialized serological tests including those targeting the RBD cannot substitute VNT for the assessment of functional antibody response.

Published
2020
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9. Impacts of users' antisocial behaviors in an ophthalmologic emergency department—a qualitative study

Author

Sandrine Touzet, Jean-Baptiste Fassier, Carole Burillon, Pierre-Loïc Cornut, Constance d’Aubarede, Antoine Duclos, Philippe Sarnin, Unité Mixte de Recherche Epidémiologique et de Surveillance Transport Travail Environnement (UMRESTTE UMR T9405), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR), Hospices Civils de Lyon (HCL), Groupe de Recherche en Psychologie Sociale (GRePS), Université Lumière - Lyon 2 (UL2), Department of Ophtalmology, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Pôle Information Médicale Evaluation Recherche (IMER), Santé Individu Société - SIS (SIS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université Lumière - Lyon 2 (UL2), and Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS)

Subjects
medicine.medical_specialty, Attitude of Health Personnel, Health Personnel, Health-care workers, Applied psychology, Poison control, [SHS.PSY]Humanities and Social Sciences/Psychology, Suicide prevention, Grounded theory, Occupational safety and health, 03 medical and health sciences, 0302 clinical medicine, Occupational Exposure, Qualitative research, Adaptation, Psychological, medicine, Humans, 030212 general & internal medicine, Antisocial behavior, Psychiatry, Workplace, Exposure to Violence, 030504 nursing, Workplace violence, business.industry, Occupational hazards, Public Health, Environmental and Occupational Health, Human factors and ergonomics, Antisocial Personality Disorder, Professional-Patient Relations, Hospitals, 3. Good health, Aggression, Ophthalmology, France, Thematic analysis, 0305 other medical science, business, Emergency Service, Hospital
Abstract

BACKGROUND: Health-care workers in emergency departments are frequently exposed to risk of antisocial behavior and violence (ABV) by users. Underreporting of ABV by health-care professionals has been identified. In order to understand this phenomenon, we explored the experience of ABV in 30 health workers in an ophthalmology emergency department in the Rhone-Alpes administrative region of France. METHODS: A grounded theory qualitative approach was followed. Data were collected from field observations, 30 semistructured individual interviews, violence report forms, and 364 patient satisfaction questionnaires. Qualitative thematic content analysis of the interviews was performed with qualitative data analysis software. RESULTS: Third-party antisocial behaviors and violence were an everyday occurrence, with varying levels of seriousness: impoliteness, vulgarity, nonrecognition, insults, verbal threats, and aggressive gestures. Health-care workers adopted various strategies to adapt to such violence: proactive and reactive attitudes and avoidance. Several organizational factors concerning the political and economic context, hospital work organization, and health workers' behavior were identified as potentially contributing to ABV. Excessive waiting times, lack of user information, and understaffing emerged as factors contributing to users' ABV. CONCLUSION: Antisocial behaviors by hospital users are underreported by professionals and under-recognized. They appear to be like continuous occupational exposure leading to delayed adverse consequences either on workers' health or motivation. However, violence in hospitals is not the result of only the action of users, and it may be related to work organization and workers' own behaviors. Only a grounded analysis of the causes of violence in the local work context can uncover relevant solutions. Language: en

Published
2015
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10. Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study

Author

Trouillet-Assant, Sophie, Albert Vega, Chloe, Bal, Antonin, Nazare, Julie Anne, Fascia, Pascal, Paul, Adèle, Massardier-Pilonchery, Amélie, d Aubarede, Constance, Guibert, Nicolas, Pitiot, Virginie, Lahousse, Matthieu, Boibieux, André, Makhloufi, Djamila, Simon, Chantal, Rabilloud, Muriel, Trabaud, Mary Anne, Gueyffier, François, Fassier, Jean-Baptiste, Centre International de Recherche en Infectiologie - UMR (CIRI), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), HCL Groupement Hospitalier Nord [Lyon], Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Hôpital Henry Gabrielle [CHU - HCL], Unité Mixte de Recherche Epidémiologique et de Surveillance Transport Travail Environnement (UMRESTTE UMR_T9405), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Gustave Eiffel, Hôpital Edouard Herriot [CHU - HCL], Université de Lyon, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de LyonFondation des Hospices Civils de Lyon, COVID-SER study group: Jérôme Adnot, Dulce Alfaiate, Antonin Bal, Alain Bergeret, André Boibieux, Florent Bonnet, Gaëlle Bourgeois, Florence Brunel-Dalmas, Eurydice Caire, Barbara Charbotel, 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, Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and CarMeN, laboratoire

Subjects
Male, SARS-CoV-2, public health, [SDV]Life Sciences [q-bio], COVID-19, General Medicine, Antibodies, Viral, diagnostic microbiology, [SDV] Life Sciences [q-bio], molecular diagnostics, Humans, Mass Screening, Female, Serologic Tests, Public Health, Prospective Studies, Pandemics
Abstract

International audience; 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.

Published
2020
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