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1. Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical–surgical procedures: the PROADAPT pilot study protocol

Author

Benjamin Riche, Laetitia Stefani, Virginie Pitiot, Vincent Collange, Mélanie Roche, Christine Ravot, Amélie Malapert, Sophie Paget-Bailly, Charlène Garandeau, Mélanie Tomatis, Béatrice Galamand, Marion Granger, Claire Barbavara, Chrystelle Bourgeois, Evelyne Genest, Max Haïne, Elisabeth Castel-Kremer, Isabelle Morel-Soldner, Olivia Le Saux, David Dayde, Claire Falandry, G. Albrand, D. Barnoud, D. Benayoun, B Billod, J. Bonhomme, A.-L. Bres, C. Brunengo, A. Chanelière, Y. Chauleur, G. Copaescu, H. Curé, A-M. Dascalita, B. De La Vigerie, S. Ducoulombier, O. Ganne, F. Gervais, T. Gilbert, M. Giroud, R. Guyot, M. Haïne, N. Jomard, C. Lecardonnel, B. Leroy, J-A. Long, A. Marion, E. Nony, S. Parent, A. Pelisset-Vanhersecke, A. Pirollet, J-E. Terrier, J. Trautmann, and M-A. Vincent

Subjects
Medicine
Abstract

Background Ageing is associated with an increased prevalence of comorbidities and sarcopenia as well as a decline of functional reserve of multiple organ systems, which may lead, in the context of the disease-related and/or treatment-related stress, to functional deconditioning. The multicomponent ‘Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning risk and Accompaniment of Patients’ Trajectories (PROADAPT)’ intervention was developed multiprofessionally to implement prehabilitation in older patients with cancer.Methods The PROADAPT pilot study is an interventional, non-comparative, prospective, multicentre study. It will include 122 patients oriented to complex medical–surgical curative procedures (major surgery or radiation therapy with or without chemotherapy). After informed consent, patients will undergo a comprehensive geriatric assessment and will be offered a prehabilitation kit that includes an advice booklet with personalised objectives and respiratory rehabilitation devices. Patients will then be called weekly and monitored for physical and respiratory rehabilitation, preoperative renutrition, motivational counselling and iatrogenic prevention. Six outpatient visits will be planned: at inclusion, a few days before the procedure and at 1, 3, 6 and 12 months after the end of the procedure. The main outcome of the study is the feasibility of the intervention, defined as the ability to perform at least one of the components of the programme. Clinical data collected will include patient-specific and cancer-specific characteristics.Ethics and dissemination The study protocol was approved by the Ile de France 8 ethics committee on 5 June 2018. The results of the primary and secondary objectives will be published in peer-reviewed journals.Trial registration number NCT03659123. Pre-results of the trial.

Published
2021
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2. 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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3. Evaluation of commercial Anti-SARS-CoV-2 neutralizing antibody assays in seropositive subjects

Author

Kahina Saker, Bruno Pozzetto, Vanessa Escuret, Virginie Pitiot, Amélie Massardier-Pilonchéry, Bouchra Mokdad, Carole Langlois-Jacques, Muriel Rabilloud, Dulce Alfaiate, Nicolas Guibert, Jean-Baptiste Fassier, Antonin Bal, Sophie Trouillet-Assant, Mary-Anne Trabaud, Hospices Civils de Lyon (HCL), Commission Spécialisée Maladies infectieuses et maladies émergentes (CSMime), Haut Conseil de la Santé Publique (HCSP), Virpath-Grippe, de l'émergence au contrôle -- Virpath-Influenza, from emergence to control (Virpath), 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), 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, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], 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)-Université Claude Bernard Lyon 1 (UCBL), 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), Institut des Agents Infectieux [Lyon] (IAI), ASTREDHOR Sud-Ouest, Association nationale des structures d'expérimentation et de démonstration en ... et de démonstration en horticulture ornementale (ASTREDHOR), Hôpital de la Croix-Rousse [CHU - HCL], and Virology and human respiratory Pathologies - Virology and human respiratory Pathologies (VirPath)

Subjects
Competitive anti-RBD immunoassays, History, Polymers and Plastics, SARS-CoV-2, Surrogate markers of protection, [SDV]Life Sciences [q-bio], COVID-19, Antibodies, Viral, Neutralizing antibodies, Antibodies, Neutralizing, Industrial and Manufacturing Engineering, Commercial tests, Infectious Diseases, Neutralization Tests, Virology, Humans, Business and International Management
Abstract

The virus neutralization test (VNT) is the reference for the assessment of the functional ability of neutralizing antibodies (NAb) to block SARS-CoV-2 entry into cells. New competitive immunoassays measuring antibodies preventing interaction between the spike protein and its cellular receptor are proposed as surrogate VNT (sVNT). We tested three commercial sVNT (a qualitative immunochromatographic test and two quantitative immunoassays named YHLO and TECO) together with a conventional anti-spike IgG assay (bioMérieux) in comparison with an in-house plaque reduction neutralization test (PRNT50) using the original 19A strain and different variants of concern (VOC), on a panel of 306 sera from naturally-infected or vaccinated patients. The qualitative test was rapidly discarded because of poor sensitivity and specificity. Areas under the curve of YHLO and TECO assays were, respectively, 85.83 and 84.07 (p-value >0.05) using a positivity threshold of 20 for PRNT50, and 95.63 and 90.35 (p-value =0.02) using a threshold of 80. However, the performances of YHLO and bioMérieux were very close for both thresholds, demonstrating the absence of added value of sVNT compared to a conventional assay for the evaluation of the presence of NAb in seropositive subjects. In addition, the PRNT50 assay showed a reduction of NAb titers towards different VOC in comparison to the 19A strain that could not be appreciated by the commercial tests. Despite the good correlation between the anti-spike antibody titer and the titer of NAb by PRNT50, our results highlight the difficulty to distinguish true NAb among the anti-RBD antibodies with commercial user-friendly immunoassays.

Published
2022
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4. Evaluation of High-Throughput SARS-CoV-2 Serological Assays in a Longitudinal Cohort of Patients with Mild COVID-19: Clinical Sensitivity, Specificity, and Association with Virus Neutralization Test

Author

Florence Morfin-Sherpa, Adèle Paul, Carole Langlois-Jacques, Sophie Trouillet-Assant, Virginie Pitiot, Constance D’Aubarède-Frieh, Bruno Pozzetto, Nicolas Guibert, David Goncalves, Jean-Baptiste Fassier, Nicole Fabien, François Gueyffier, Antonin Bal, Mary-Anne Trabaud, Amélie Massardier-Pilonchery, Bruno Lina, Muriel Rabilloud, Vanessa Escuret, and André Boibieux

Subjects
Adult, Male, 0301 basic medicine, Coronavirus disease 2019 (COVID-19), Health-care workers, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Concordance, 030106 microbiology, Clinical Biochemistry, Virus Neutralization, Antibodies, Viral, Sensitivity and Specificity, Article, COVID-19 Serological Testing, Serology, Cohort Studies, 03 medical and health sciences, Neutralization Tests, Humans, Medicine, Longitudinal Studies, Prospective Studies, Neutralizing antibody, Aged, Biochemistry, medical, biology, SARS-CoV-2, business.industry, Biochemistry (medical), COVID-19, Virus neutralization, Antibodies, Neutralizing, Virology, Titer, 030104 developmental biology, biology.protein, Female, Antibody, business, Serological assays
Abstract

Background The association between SARS-CoV-2 commercial serological assays and virus neutralization test (VNT) has been poorly explored in mild patients with COVID-19. Methods 439 serum specimens were longitudinally collected from 76 healthcare workers with RT-PCR-confirmed COVID-19. The clinical sensitivity (determined weekly) of 9 commercial serological assays were evaluated. Clinical specificity was assessed using 69 pre-pandemic sera. Correlation, agreement, and concordance with the VNT were also assessed on a subset of 170 samples. Area under the ROC curve (AUC) was estimated at 2 neutralizing antibody titers. Results The 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 clinical specificity was greater than 95% for all tests except for the Euroimmun IgA assay. The overall agreement with the presence of neutralizing antibodies ranged from 62.2% (95%CI; 56.0–68.1) for bioMérieux IgM to 91.2% (87.0–94.2) for Siemens. The lowest negative percent agreement (NPA) was found with the Wantai Total Ab assay (NPA 33% (21.1–48.3)). The NPA for other total Ab or IgG assays targeting the S or the RBD was 80.7% (66.7–89.7), 90.3% (78.1–96.1), and 96.8% (86.8–99.3) for Siemens, bioMérieux IgG, and DiaSorin, respectively. None of the commercial assays have sufficient performance to detect a neutralizing titer of 80 (AUC Conclusions Although some assays show a better agreement with VNT than others, the present findings emphasize that commercialized serological tests, including those targeting the RBD, cannot substitute a VNT for the assessment of functional antibody response.

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. Evaluation of Commercial Anti-SARS-CoV-2 Antibody Assays and Comparison of Standardized Titers in Vaccinated Health Care Workers

Author

Sophie Trouillet-Assant, Nicole Fabien, Amélie Massardier-Pilonchery, Muriel Rabilloud, Carole Langlois-Jacques, Virginie Pitiot, Jean-Baptiste Fassier, Stéphane Paul, Bouchra Mokdad, Vanessa Escuret, David Goncalves, Kahina Saker, Nicolas Guibert, Antonin Bal, Mary-Anne Trabaud, 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), Virpath-Grippe, de l'émergence au contrôle -- Virpath-Influenza, from emergence to control (Virpath), 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), 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, Physiopathologie et biothérapies des infections muqueuses (GIMAP), Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], 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)-Université Claude Bernard Lyon 1 (UCBL), 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), IFP Energies nouvelles (IFPEN), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), ANR-21-COVR-0038,COVIDIgS,Comparaison du role des anticorps IgA/IgM systémique et muqueux dans la physiopathologie et la sévérité de la COVID-19(2021), 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), 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
Microbiology (medical), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], Health Personnel, Antibodies, Viral, World health, 03 medical and health sciences, 0302 clinical medicine, Antigen, Medicine, Humans, 030212 general & internal medicine, Seroconversion, 030304 developmental biology, 0303 health sciences, biology, 030306 microbiology, business.industry, SARS-CoV-2, Vaccination, Antibody titer, COVID-19, Virology, 3. Good health, Titer, Spike Glycoprotein, Coronavirus, biology.protein, Antibody, business
Abstract

With the availability of vaccines, commercial assays detecting anti-SARS-CoV-2 antibodies (Ab) evolved towards quantitative assays directed to the spike glycoprotein or its receptor binding domain (RBD). The main objective of the present study was to compare the Ab titers obtained with quantitative commercial binding Ab assays, after 1 dose (convalescent individuals) or 2 doses (naïve individuals) of vaccine, in healthcare workers (HCW).Antibody titers were measured in 255 sera (from 150 HCW) with 5 quantitative immunoassays (Abbott RBD IgG II quant, bioMérieux RBD IgG, DiaSorin Trimeric spike IgG, Siemens Healthineers RBD IgG, Wantai RBD IgG). One qualitative total antibody anti RBD detection assay (Wantai) was used to detect previous infection before vaccination. The results are presented in binding Ab units (BAU)/mL after application, when possible, of a conversion factor provided by the manufacturers and established from a World Health Organization (WHO) internal standard.There was a 100% seroconversion with all assays evaluated after two doses of vaccine. With assays allowing BAU/ml correction, Ab titers were correlated (Pearson correlation coefficient, ρ, range: 0.85-0.94). The titer differences varied by a mean of 10.6% between Siemens and bioMérieux assays to 60.9% between Abbott and DiaSorin assays. These results underline the importance of BAU conversion for the comparison of Ab titer obtained with the different quantitative assays. However, significant differences persist, notably, between kits detecting Ab against the different antigens.A true standardization of the assays would be to include the International Standard in the calibration of each assays to express the results in IU/mL.

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

Author

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, d'Aubarede, Constance, François, Durupt, Vanessa, Escuret, Pascal, Fascia, Jean-Baptiste, Fassier, Juliette, Fontaine, Lucie, Gaillot-Durand, Alexandre, Gaymard, Myriam, Gillet, Matthieu, Godinot, François, Gueyffier, Nicolas, Guibert, Laurence, Josset, Matthieu, Lahousse, Bruno, Lina, Hélène, Lozano, Djamila, Makhloufi, Amélie, Massardier-Pilonchéry, Marie-Paule, Milon, Frédéric, Moll, Florence, Morfin, David, Narbey, Julie-Anne, Nazare, Fatima, Oria, Adèle, Paul, Marielle, Perry, Virginie, Pitiot, Mélanie, Prudent, Muriel, Rabilloud, Audrey, Samperiz, Isabelle, Schlienger, Chantal, Simon, Mary-Anne, Trabaud, Sophie, Trouillet-Assant, Martine, Valette, Bal, Antonin, Trabaud, Mary-Anne, Fassier, Jean-Baptiste, Rabilloud, Muriel, Saker, Kahina, Langlois-Jacques, Carole, Guibert, Nicolas, Paul, Adèle, Alfaiate, Dulce, Massardier-Pilonchery, Amélie, Pitiot, Virginie, Morfin-Sherpa, Florence, Lina, Bruno, Pozzetto, Bruno, and Trouillet-Assant, Sophie

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

Author

Bal, Antonin, primary, Trabaud, Mary-Anne, additional, Fassier, Jean-Baptiste, additional, Rabilloud, Muriel, additional, Saker, Kahina, additional, Langlois-Jacques, Carole, additional, Guibert, Nicolas, additional, Paul, Adèle, additional, Alfaiate, Dulce, additional, Massardier-Pilonchery, Amélie, additional, Pitiot, Virginie, additional, Morfin-Sherpa, Florence, additional, Lina, Bruno, additional, Pozzetto, Bruno, additional, Trouillet-Assant, Sophie, additional, Jérôme, Adnot, additional, Dulce, Alfaiate, additional, Antonin, Bal, additional, Alain, Bergeret, additional, André, Boibieux, additional, Florent, Bonnet, additional, Gaëlle, Bourgeois, additional, Florence, Brunel-Dalmas, additional, Eurydice, Caire, additional, Barbara, Charbotel, additional, Pierre, Chiarello, additional, Laurent, Cotte, additional, d'Aubarede, Constance, additional, François, Durupt, additional, Vanessa, Escuret, additional, Pascal, Fascia, additional, Jean-Baptiste, Fassier, additional, Juliette, Fontaine, additional, Lucie, Gaillot-Durand, additional, Alexandre, Gaymard, additional, Myriam, Gillet, additional, Matthieu, Godinot, additional, François, Gueyffier, additional, Nicolas, Guibert, additional, Laurence, Josset, additional, Matthieu, Lahousse, additional, Bruno, Lina, additional, Hélène, Lozano, additional, Djamila, Makhloufi, additional, Amélie, Massardier-Pilonchéry, additional, Marie-Paule, Milon, additional, Frédéric, Moll, additional, Florence, Morfin, additional, David, Narbey, additional, Julie-Anne, Nazare, additional, Fatima, Oria, additional, Adèle, Paul, additional, Marielle, Perry, additional, Virginie, Pitiot, additional, Mélanie, Prudent, additional, Muriel, Rabilloud, additional, Audrey, Samperiz, additional, Isabelle, Schlienger, additional, Chantal, Simon, additional, Mary-Anne, Trabaud, additional, Sophie, Trouillet-Assant, additional, and Martine, Valette, additional

Published
2021
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9. 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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