Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study. Issue 11 (24th November 2020)

• Record Type: Journal Article
• Authors: 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
• Other Names: author non-byline.; Adnot Jérôme author non-byline.; Alfaiate Dulce author non-byline.; Bal Antonin author non-byline.; Bergeret Alain author non-byline.; Boibieux André author non-byline.; Bonnet Florent author non-byline.; Bourgeois Gaëlle author non-byline.; Brunel-Dalmas Florence author non-byline.; Caire Eurydice author non-byline.; Charbotel Barbara author non-byline.; Chiarello Pierre author non-byline.; Cotte Laurent author non-byline.; d'Aubarede Constance author non-byline.; Durupt François author non-byline.; Vanessa Escuret author non-byline.; Pascal Fascia author non-byline.; Jean-Baptiste Fassier author non-byline.; Juliette Fontaine author non-byline.; Lucie Gaillot-Durand author non-byline.; Alexandre Gaymard author non-byline.; Myriam Gillet author non-byline.; Matthieu Godinot author non-byline.; François Gueyffier author non-byline.; Nicolas Guibert author non-byline.; Laurence Josset author non-byline.; Matthieu Lahousse author non-byline.; Bruno Lina author non-byline.; Hélène Lozano author non-byline.; Djamila Makhloufi author non-byline.; Amélie Massardier-Pilonchéry author non-byline.; Marie-Paule Milon author non-byline.; Frédéric Moll author non-byline.; Florence Morfin author non-byline.; David Narbey author non-byline.; Julie-Anne Nazare author non-byline.; Fatima Oria author non-byline.; Adèle Paul author non-byline.; Marielle Perry author non-byline.; Virginie Pitiot author non-byline.; Mélanie Prudent author non-byline.; Muriel Rabilloud author non-byline.; Audrey Samperiz author non-byline.; Isabelle Schlienger author non-byline.; Chantal Simon author non-byline.; Mary-Anne Trabaud author non-byline.; Sophie Trouillet-Assant author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-24
• Subjects: public health -- molecular diagnostics -- diagnostic microbiology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-041268
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .