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Evaluation of 31 Commercial SARS-CoV-2 Serology Assays

30 Pages Posted: 22 Oct 2020

See all articles by Christelle Vauloup Fellous

Christelle Vauloup Fellous

Hôpital Paul-Brousse - Service de Virologie

Sarah Maylin

University of Paris - Hôpital Saint-Louis

Claire Dubois

University Paris Saclay - Service de Virologie

Segolene Brichler

Université Paris Nord - Laboratoire de Microbiologie Clinique

Ahmed-Chakib Alloui

Université Paris Nord - Laboratoire de Microbiologie Clinique

Nerville-Emmanuel Gordien

Université Paris Nord - Laboratoire de Microbiologie Clinique

Marie-Anne Rameix Welti

University of Paris-Saclay - Laboratoire de Microbiologie

Elyanne Gault

University of Paris-Saclay - Laboratoire de Microbiologie

Frédérique Moreau

University of Paris-Saclay - Laboratoire de Microbiologie

Slim Fourati

Department of Microbiology, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris(AP-HP)

Dominique Challine

Hôpital Henri Mondor - Université Paris-Est, "Viruses, Hepatology, Cancer" Research Unit

Jean michel Pawlotsky

Hôpital Henri Mondor - Université Paris-Est, "Viruses, Hepatology, Cancer" Research Unit

Nadhira Houhou

Université de Paris - Laboratoire de Virologie

Florence Damond

Université de Paris - Laboratoire de Virologie

Vincent Mackiewicz

Université de Paris - Laboratoire de Virologie

Charlotte Charpentier

Université de Paris - Laboratoire de Virologie

Jean-François Meritet

Université de Paris - Service de Virologie

Flore Rozenberg

Equipe Mobile d’Infectiologie, AP-HP, Hôpital Cochin

Isabelle Podglajen

Université de Paris - Service de Virologie

Stephane sylvain Marot

Sorbonne University - Laboratoire de virologie

Heloise Petit

Sorbonne University - Laboratoire de virologie

Sonia Burrel

Sorbonne University - Laboratoire de virologie

Sepideh Akhavan

Sorbonne University - Laboratoire de virologie

Marianne Leruez-Ville

University of Paris - Reference Laboratory for Cytomegalovirus Infections

Véronique Avettand Fenoel

Université de Paris - APHP Laboratoire de Microbiologie clinique

Jacques Fourgeaud

Laboratoire De Virologie, AP-HP, Hôpital Necker-Enfants Malades

Tiffany Guilleminot

Universite Paris Descartes; University of Paris - Reference Laboratory for Cytomegalovirus Infections

Elise Gardiennet

AP-HP, CHU Necker Enfants Malades,EA 7327 Université Paris Descartes

Stéphane Bonacorsi

Université de Paris - Service de Microbiologie

Agnès Carol

Université de Paris - Service de Microbiologie

Guislaine Carcelain

Université de Paris - Département d'Immunologie

Juliette Villemonteix

Université de Paris - Département d'Immunologie

Narjis Boukli-Hacene

Sorbonne University - Département de Virologie

Joël-Meyer Gozlan

Sorbonne University - Département de Virologie

Laurence Morand-Joubert

Sorbonne University - Département de Virologie

Jérôme Le Goff

University of Paris - Hôpital Saint-Louis; Université Paris 7, Hôpital Saint Louis - Service de Virologie

Constance Delaugerre

Université Paris VII Denis Diderot - INSERM U941; Université Paris 7, Hôpital Saint Louis - Service de Virologie

Marie-Laure Chaix Baudier

University of Paris - Hôpital Saint-Louis

Anne-Marie Roque Afonso

University Paris Saclay - Service de Virologie

Laurent Dortet

Hôpital Bicêtre - Service de Bactériologie-hygiène

Thierry Naas

Hôpital Bicêtre - Service de Bactériologie-hygiène

Jean-Baptiste Rona

Médecins Sans Frontières - Mini-Lab project

Samuel Le Pape

University Paris Saclay - Service de Virologie

Anne-Geneviève Marcelin

Sorbonne Université - Laboratoire de virologie

Diane Descamps

Université de Paris - Laboratoire de Virologie

More...

Abstract

Background: The virus responsible of severe acute respiratory syndrome named SARS-CoV-2 and causing the new coronavirus disease (COVID-19) has gone global within three months. The current gold standard technique used to detect SARS-CoV-2 is real-time reverse transcription-polymerase chain reaction (rRT-PCR) from naso-pharyngeal swabs but it may be negative in up to 30% of COVID-19 patients. Detection of specific antibodies against SARS-CoV-2 may therefore enhance sensitivity of the current biological diagnosis, as well as monitor the extent of the epidemics in global or specific population, such as health-care worker. Many serological assays are currently available, but their clinical performances are still to be evaluated.

Material and Method: A total of 2,594 serum samples collected from patients with SARS-CoV-2 infection documented by a positive rRT-PCR were enrolled in this study. They were tested for IgM/IgG/IgA against SARS-CoV-2 using 31 commercial assays. Antibody response was assessed depending on the onset of symptoms. In addition, 1,996 pre-epidemic serum samples expected to be negative were tested to assess specificity.

Results: Rapid tests for qualitative detection of anti-SARS-CoV-2 antibodies (RDTs) achieved 77.4-100%, and ELISA/CLIA (ELISA) assays 58.8-100% for SARS-CoV-2-specific total antibodies (TAb) specificity. From 15 days after onset of symptoms, 13/18 RDT and 8/13 ELISA reached sensitivity > 90%. However, only 4 RDT and 3 ELISA assays fitted both sensitivity (> 90%) and specificity (> 98%) criteria according to French recommendations.

Conclusions: Serology may offer valuable information during the course of COVID-19 pandemic, at the condition that commercial assays give reliable results. Contrasted performances were observed among the 31 commercial assays we evaluated, which underlines the importance of independent evaluation before clinical implementation.

Funding Statement: This study was funded by the Agence Nationale de Recherche sur le SIDA et les Hépatites Virales (ANRS, AC43)".

Declaration of Interests: JM Pawlotsky has served as an advisor and/or a speaker for Abbvie, Gilead, GlaxoSmithKline, Merck, Regulus and Siemens Healthcare. C Vauloup-Fellous served as un expert (rubella and CMV serology) for Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare and DiaSorin. No other authors have any competing interests to declare.

Ethics Approval Statement: The study was carried out in accordance with the Declaration of Helsinki. This work was a retrospective non-interventional study with no addition to standard care procedures. Reclassification of biological remnants into research material after completion of the ordered virological tests was approved by the local interventional review board of hospital. According to the French Public Health Code (CSP Article L.1121-1.1) such protocols are exempted from individual informed consent.

Keywords: Serology, SARS-CoV-2, COVID-19

Suggested Citation

Vauloup Fellous, Christelle and Maylin, Sarah and Dubois, Claire and Brichler, Segolene and Alloui, Ahmed-Chakib and Gordien, Nerville-Emmanuel and Rameix Welti, Marie-Anne and Gault, Elyanne and Moreau, Frédérique and Fourati, Slim and Challine, Dominique and Pawlotsky, Jean michel and Houhou, Nadhira and Damond, Florence and Mackiewicz, Vincent and Charpentier, Charlotte and Meritet, Jean-François and Rozenberg, Flore and Podglajen, Isabelle and Marot, Stephane sylvain and Petit, Heloise and Burrel, Sonia and Akhavan, Sepideh and Leruez-Ville, Marianne and Avettand Fenoel, Véronique and Fourgeaud, Jacques and Guilleminot, Tiffany and Gardiennet, Elise and Bonacorsi, Stéphane and Carol, Agnès and Carcelain, Guislaine and Villemonteix, Juliette and Boukli-Hacene, Narjis and Gozlan, Joël-Meyer and Morand-Joubert, Laurence and Le Goff, Jérôme and Delaugerre, Constance and Chaix Baudier, Marie-Laure and Roque Afonso, Anne-Marie and Dortet, Laurent and Naas, Thierry and Rona, Jean-Baptiste and Le Pape, Samuel and Marcelin, Anne-Geneviève and Descamps, Diane, Evaluation of 31 Commercial SARS-CoV-2 Serology Assays. Available at SSRN: https://ssrn.com/abstract=3696824 or http://dx.doi.org/10.2139/ssrn.3696824

Christelle Vauloup Fellous (Contact Author)

Hôpital Paul-Brousse - Service de Virologie ( email )

France

Sarah Maylin

University of Paris - Hôpital Saint-Louis ( email )

Paris
France

Claire Dubois

University Paris Saclay - Service de Virologie ( email )

France

Segolene Brichler

Université Paris Nord - Laboratoire de Microbiologie Clinique ( email )

Avenue Jean Baptiste Clement
Villetaneuse, Seine Saint Denis 93430
France

Ahmed-Chakib Alloui

Université Paris Nord - Laboratoire de Microbiologie Clinique ( email )

Avenue Jean Baptiste Clement
Villetaneuse, Seine Saint Denis 93430
France

Nerville-Emmanuel Gordien

Université Paris Nord - Laboratoire de Microbiologie Clinique ( email )

Avenue Jean Baptiste Clement
Villetaneuse, Seine Saint Denis 93430
France

Marie-Anne Rameix Welti

University of Paris-Saclay - Laboratoire de Microbiologie ( email )

55 Avenue de Paris
Versailles, 78000
France

Elyanne Gault

University of Paris-Saclay - Laboratoire de Microbiologie ( email )

55 Avenue de Paris
Versailles, 78000
France

Frédérique Moreau

University of Paris-Saclay - Laboratoire de Microbiologie ( email )

55 Avenue de Paris
Versailles, 78000
France

Slim Fourati

Department of Microbiology, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris(AP-HP)

Dominique Challine

Hôpital Henri Mondor - Université Paris-Est, "Viruses, Hepatology, Cancer" Research Unit ( email )

51 Avenue du Maréchal de Lattre de Tassigny
Créteil, 94010
France

Jean michel Pawlotsky

Hôpital Henri Mondor - Université Paris-Est, "Viruses, Hepatology, Cancer" Research Unit ( email )

51 Avenue du Maréchal de Lattre de Tassigny
Créteil, 94010
France

Nadhira Houhou

Université de Paris - Laboratoire de Virologie ( email )

Paris
France

Florence Damond

Université de Paris - Laboratoire de Virologie ( email )

Paris
France

Vincent Mackiewicz

Université de Paris - Laboratoire de Virologie ( email )

Paris
France

Charlotte Charpentier

Université de Paris - Laboratoire de Virologie ( email )

Paris
France

Jean-François Meritet

Université de Paris - Service de Virologie ( email )

Paris
France

Flore Rozenberg

Equipe Mobile d’Infectiologie, AP-HP, Hôpital Cochin

Isabelle Podglajen

Université de Paris - Service de Virologie ( email )

Paris
France

Stephane sylvain Marot

Sorbonne University - Laboratoire de virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Heloise Petit

Sorbonne University - Laboratoire de virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Sonia Burrel

Sorbonne University - Laboratoire de virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Sepideh Akhavan

Sorbonne University - Laboratoire de virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Marianne Leruez-Ville

University of Paris - Reference Laboratory for Cytomegalovirus Infections ( email )

Paris, 75015
France

Véronique Avettand Fenoel

Université de Paris - APHP Laboratoire de Microbiologie clinique ( email )

Paris
France

Jacques Fourgeaud

Laboratoire De Virologie, AP-HP, Hôpital Necker-Enfants Malades

Tiffany Guilleminot

Universite Paris Descartes

12, rue de l'Ecole de Médecine
Cedex 06
Paris, 75270
France

University of Paris - Reference Laboratory for Cytomegalovirus Infections

Paris, 75015
France

Elise Gardiennet

AP-HP, CHU Necker Enfants Malades,EA 7327 Université Paris Descartes

12, rue de l'Ecole de Médecine
Cedex 06
Paris, 75270
France

Stéphane Bonacorsi

Université de Paris - Service de Microbiologie ( email )

Paris
France

Agnès Carol

Université de Paris - Service de Microbiologie ( email )

Paris
France

Guislaine Carcelain

Université de Paris - Département d'Immunologie ( email )

Paris
France

Juliette Villemonteix

Université de Paris - Département d'Immunologie ( email )

Paris
France

Narjis Boukli-Hacene

Sorbonne University - Département de Virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Joël-Meyer Gozlan

Sorbonne University - Département de Virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Laurence Morand-Joubert

Sorbonne University - Département de Virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Jérôme Le Goff

University of Paris - Hôpital Saint-Louis ( email )

Paris
France

Université Paris 7, Hôpital Saint Louis - Service de Virologie ( email )

United States

Constance Delaugerre

Université Paris VII Denis Diderot - INSERM U941

Paris, 75010
France

Université Paris 7, Hôpital Saint Louis - Service de Virologie ( email )

United States

Marie-Laure Chaix Baudier

University of Paris - Hôpital Saint-Louis ( email )

Paris
France

Anne-Marie Roque Afonso

University Paris Saclay - Service de Virologie ( email )

France

Laurent Dortet

Hôpital Bicêtre - Service de Bactériologie-hygiène

France

Thierry Naas

Hôpital Bicêtre - Service de Bactériologie-hygiène ( email )

France

Jean-Baptiste Rona

Médecins Sans Frontières - Mini-Lab project ( email )

Samuel Le Pape

University Paris Saclay - Service de Virologie ( email )

France

Anne-Geneviève Marcelin

Sorbonne Université - Laboratoire de virologie ( email )

UFR 927, 4 Place Jussieu
Paris, PA F-75252
France

Diane Descamps

Université de Paris - Laboratoire de Virologie ( email )

Paris
France