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

DOI
https://doi.org/10.1136/bmjopen-2020-041268
Journal volume & issue
Vol. 10, no. 11

Abstract

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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.