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      Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

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          Abstract

          Serological assays can contribute to the estimation of population proportions with previous immunologically relevant contact with the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) virus. In this study, we compared five commercially available diagnostic assays for the diagnostic identification of SARS-CoV-2-specific antibodies. Depending on the assessed immunoglobulin subclass, recorded sensitivity ranged from 17.0% to 81.9% with best results for immunoglobulin G. Specificity with blood donor sera ranged from 90.2% to 100%, with sera from EBV patients it ranged from 84.3% to 100%. Agreement from fair to nearly perfect was recorded depending on the immunoglobulin class between the assays, the with best results being found for immunoglobulin G. Only for this immunoglobulin class was the association between later sample acquisition times (about three weeks after first positive PCR results) and positive serological results in COVID-19 patients confirmed. In conclusion, acceptable and comparable reliability for the assessed immunoglobulin G-specific assays could be shown, while there is still room for improvement regarding the reliability of the assays targeting the other immunoglobulin classes.

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          A pneumonia outbreak associated with a new coronavirus of probable bat origin

          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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            The Measurement of Observer Agreement for Categorical Data

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              Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

              Background The ongoing outbreak of the recently emerged novel coronavirus (2019-nCoV) poses a challenge for public health laboratories as virus isolates are unavailable while there is growing evidence that the outbreak is more widespread than initially thought, and international spread through travellers does already occur. Aim We aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available. Methods Here we present a validated diagnostic workflow for 2019-nCoV, its design relying on close genetic relatedness of 2019-nCoV with SARS coronavirus, making use of synthetic nucleic acid technology. Results The workflow reliably detects 2019-nCoV, and further discriminates 2019-nCoV from SARS-CoV. Through coordination between academic and public laboratories, we confirmed assay exclusivity based on 297 original clinical specimens containing a full spectrum of human respiratory viruses. Control material is made available through European Virus Archive – Global (EVAg), a European Union infrastructure project. Conclusion The present study demonstrates the enormous response capacity achieved through coordination of academic and public laboratories in national and European research networks.
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                Author and article information

                Journal
                Diagnostics (Basel)
                Diagnostics (Basel)
                diagnostics
                Diagnostics
                MDPI
                2075-4418
                06 January 2021
                January 2021
                : 11
                : 1
                : 78
                Affiliations
                [1 ]Institute for Medical Microbiology, University Medical Center Göttingen, 37075 Göttingen, Germany; anja.doerschug@ 123456stud.uni-goettingen.de (A.D.); julian.schwanbeck@ 123456med.uni-goettingen.de (J.S.); kemal.mese@ 123456med.uni-goettingen.de (K.M.); ugross@ 123456gwdg.de (U.G.)
                [2 ]Institute for Medical Microbiology, Virology and Hygiene, University Medicine Rostock, 18057 Rostock, Germany; andreas.hahn@ 123456uni-rostock.de (A.H.); hagen.frickmann@ 123456med.uni-rostock.de (H.F.)
                [3 ]Interdisciplinary Emergency Department, University Medical Center Göttingen, 37075 Göttingen, Germany; anke.hillebrecht@ 123456med.uni-goettingen.de (A.H.); sblasch@ 123456gwdg.de (S.B.)
                [4 ]Institute for Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany; sascha.dierks@ 123456med.uni-goettingen.de
                [5 ]Department of Microbiology and Hospital Hygiene, Bundeswehr Hospital Hamburg, 20359 Hamburg, Germany
                Author notes
                [* ]Correspondence: azautne@ 123456gwde.de ; Tel.: +49-551-39-65927
                [†]

                These authors contributed equally to this work.

                Author information
                https://orcid.org/0000-0003-2803-0167
                https://orcid.org/0000-0002-5157-8369
                https://orcid.org/0000-0001-8800-7554
                https://orcid.org/0000-0002-8967-9528
                Article
                diagnostics-11-00078
                10.3390/diagnostics11010078
                7825051
                33418886
                3dd65cfc-0df1-451c-ae6a-e2a9d7235dd2
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 21 December 2020
                : 04 January 2021
                Categories
                Article

                sars-cov-2,covid-19,serology,test comparison,surveillance
                sars-cov-2, covid-19, serology, test comparison, surveillance

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