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      Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG

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          Highlights

          • •

            4 new SARS-CoV-2 IgG assays can identify individuals with past SARS-CoV-2 infection

          • •

            Combination of two different assays may increase sensitivity and specificity

          Abstract

          Background

          Facing the ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is an urgent need for serological assays identifying individuals with past coronavirus disease 2019 (COVID-19).

          Study Design

          Our study is the first to compare four new commercially available assays using 75 sera from patients tested positive or negative by SARS-CoV-2 PCR: the anti SARS-CoV-2 ELISA (IgG) (Euroimmun, Germany), the EDI New Coronavirus COVID-19 IgG ELISA, (Epitope diagnostics (EDI), USA), the recomWell SARS-CoV-2 IgG ELISA (Mikrogen, Germany), and the SARS-CoV-2 Virachip IgG (Viramed, Germany).

          Results

          We found a sensitivity of 86.4%, 100%, 86.4%, and 77.3% and a specificity of 96,2%, 88,7%, 100%, and 100% for the Euroimmun assay, the EDI assay, the Mikrogen assay, and the Viramed assay, respectively.

          Conclusions

          Commercially available SARS-CoV-2 IgG assays have a sufficient specificity and sensitivity for identifying individuals with past SARS-CoV-2 infection.

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Na Zhu, Dingyu Zhang, Wenling Wang … (2020)
          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
          Article 0 comments Cited 12703 times – based on 0 reviews     Review now
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            A pneumonia outbreak associated with a new coronavirus of probable bat origin

            Peng Zhou, Xing-Lou Yang, Xian-Guang Wang … (2020)
            Since the outbreak of severe acute respiratory syndrome (SARS) 18 years ago, a large number of SARS-related coronaviruses (SARSr-CoVs) have been discovered in their natural reservoir host, bats 1–4 . Previous studies have shown that some bat SARSr-CoVs have the potential to infect humans 5–7 . Here we report the identification and characterization of a new coronavirus (2019-nCoV), which caused an epidemic of acute respiratory syndrome in humans in Wuhan, China. The epidemic, which started on 12 December 2019, had caused 2,794 laboratory-confirmed infections including 80 deaths by 26 January 2020. Full-length genome sequences were obtained from five patients at an early stage of the outbreak. The sequences are almost identical and share 79.6% sequence identity to SARS-CoV. Furthermore, we show that 2019-nCoV is 96% identical at the whole-genome level to a bat coronavirus. Pairwise protein sequence analysis of seven conserved non-structural proteins domains show that this virus belongs to the species of SARSr-CoV. In addition, 2019-nCoV virus isolated from the bronchoalveolar lavage fluid of a critically ill patient could be neutralized by sera from several patients. Notably, we confirmed that 2019-nCoV uses the same cell entry receptor—angiotensin converting enzyme II (ACE2)—as SARS-CoV.
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              Severe Acute Respiratory Syndrome Coronavirus 2−Specific Antibody Responses in Coronavirus Disease Patients

              Nisreen M.A. Okba, Marcel A. Müller, Wentao Li … (2020)
              A new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has recently emerged to cause a human pandemic. Although molecular diagnostic tests were rapidly developed, serologic assays are still lacking, yet urgently needed. Validated serologic assays are needed for contact tracing, identifying the viral reservoir, and epidemiologic studies. We developed serologic assays for detection of SARS-CoV-2 neutralizing, spike protein–specific, and nucleocapsid-specific antibodies. Using serum samples from patients with PCR-confirmed SARS-CoV-2 infections, other coronaviruses, or other respiratory pathogenic infections, we validated and tested various antigens in different in-house and commercial ELISAs. We demonstrated that most PCR-confirmed SARS-CoV-2–infected persons seroconverted by 2 weeks after disease onset. We found that commercial S1 IgG or IgA ELISAs were of lower specificity, and sensitivity varied between the 2 assays; the IgA ELISA showed higher sensitivity. Overall, the validated assays described can be instrumental for detection of SARS-CoV-2–specific antibodies for diagnostic, seroepidemiologic, and vaccine evaluation studies.
              Article 0 comments Cited 753 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Michael Kleines
                Journal
                Journal ID (nlm-ta): J Clin Virol
                Journal ID (iso-abbrev): J. Clin. Virol
                Title: Journal of Clinical Virology
                Publisher: Elsevier B.V.
                ISSN (Print): 1386-6532
                ISSN (Electronic): 1873-5967
                Publication date PMC-release: 29 April 2020
                Publication date (Electronic): 29 April 2020
                Electronic Location Identifier: 104394
                Affiliations
                [1 ]Laboratory Diagnostic Center, University Hospital RWTH Aachen, Germany
                [2 ]Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Germany
                [3 ]Department of Medical Microbiology, University Hospital RWTH Aachen, Germany
                Author notes
                [* ]Corresponding author at: Labordiagnostisches Zentrum, University Hospital RWTH Aachen, Pauwelsstr. 30, 52074 Aachen, Germany. mkleines@ 123456ukaachen.de
                Article
                Publisher ID: S1386-6532(20)30136-0 Publisher ID: 104394
                DOI: 10.1016/j.jcv.2020.104394
                PMC ID: 7189838
                PubMed ID: 32416599
                SO-VID: 493444f8-7e6b-4799-a512-864ed554d86b
                Copyright © © 2020 Elsevier B.V. All rights reserved.
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 16 April 2020
                Date revision received : 22 April 2020
                Date accepted : 27 April 2020
                Categories
                Subject: Article

                ScienceOpen disciplines: Microbiology & Virology
                Keywords: covid-19,elisa,sars-cov-2
                Data availability:
                ScienceOpen disciplines: Microbiology & Virology
                Keywords: covid-19, elisa, sars-cov-2

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