A serological assay to detect SARS-CoV-2 seroconversion in humans.,medRxiv - Allergy and Immunology

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A serological assay to detect SARS-CoV-2 seroconversion in humans.
medRxiv - Allergy and Immunology Pub Date : 2020-04-16 , DOI: 10.1101/2020.03.17.20037713
Fatima Amanat _{1,

2} , Daniel Stadlbauer ₁ , Shirin Strohmeier _{1,

3} , Thi H O Nguyen ₄ , Veronika Chromikova ₁ , Meagan McMahon ₁ , Kaijun Jiang ₁ , Guha Asthagiri Arunkumar _{1,

2} , Denise Jurczyszak _{1,

2} , Jose Polanco _{1,

5} , Maria Bermudez-Gonzalez ₁ , Giulio Kleiner ₁ , Teresa Aydillo ₁ , Lisa Miorin ₁ , Daniel Fierer ₆ , Luz Amarilis Lugo ₆ , Erna Milunka Kojic ₆ , Jonathan Stoever ₇ , Sean T H Liu ₆ , Charlotte Cunningham-Rundles ₈ , Philip L Felgner ₉ , Thomas Moran ₁ , Adolfo Garcia-Sastre _{1,

10} , Daniel Caplivski ₁₁ , Allen Cheng ₁₂ , Katherine Kedzierska ₄ , Olli Vapalahti _{13,

14,

15} , Jussi M Hepojoki _{13,

16} , Viviana Simon _{1,

6,

10} , Florian Krammer ₁

Affiliation

Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Graduate School of Biomedical Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna, Austria.
Department of Microbiology & Immunology, University of Melbourne, The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.
Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Division of Pulmonary, Critical Care, and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Pediatrics and Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Physiology & Biophysics, University of California, Irvine, CA, USA.
Global Health Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, NY, USA.
Travel Medicine Program, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
School of Public Health and Preventive Medicine, Monash University; Infection Prevention and Healthcare Epidemiology Unit, Alfred Health.
Department of Virology, Medicum, University of Helsinki, Helsinki, Finland.
Veterinary Biosciences, Veterinary Faculty, University of Helsinki, Helsinki, Finland.
Department of Virology and Immunology, Helsinki University Hospital (HUSLAB), Helsinki, Finland.
Institute of Veterinary Pathology, Vetsuisse Faculty, University of Zürich, Zürich, Switzerland.

SARS-Cov-2 (severe acute respiratory disease coronavirus 2), which causes Coronavirus Disease 2019 (COVID19) was first detected in China in late 2019 and has since then caused a global pandemic. While molecular assays to directly detect the viral genetic material are available for the diagnosis of acute infection, we currently lack serological assays suitable to specifically detect SARS-CoV-2 antibodies. Here we describe serological enzyme-linked immunosorbent assays (ELISA) that we developed using recombinant antigens derived from the spike protein of SARS-CoV-2. Using negative control samples representing pre-COVID 19 background immunity in the general adult population as well as samples from COVID19 patients, we demonstrate that these assays are sensitive and specific, allowing for screening and identification of COVID19 seroconverters using human plasma/serum as early as two days post COVID19 symptoms onset. Importantly, these assays do not require handling of infectious virus, can be adjusted to detect different antibody types and are amendable to scaling. Such serological assays are of critical importance to determine seroprevalence in a given population, define previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. Sensitive and specific identification of coronavirus SARS-Cov-2 antibody titers may, in the future, also support screening of health care workers to identify those who are already immune and can be deployed to care for infected patients minimizing the risk of viral spread to colleagues and other patients.

更新日期：2020-04-16

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