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      Multicenter Evaluation of the Clinical Performance and the Neutralizing Antibody Activity Prediction Properties of 10 High-Throughput Serological Assays Used in Clinical Laboratories

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          Abstract

          As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specificity and positive predictive values are needed to obtain an accurate epidemiological picture.

          ABSTRACT

          As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specificity and positive predictive values are needed to obtain an accurate epidemiological picture. As more data accumulate about the immune responses and the kinetics of neutralizing-antibody (nAb) production in SARS-CoV-2-infected individuals, new applications are forecast for serological assays such as nAb activity prediction in convalescent-phase plasma from recovered patients. This multicenter study, involving six hospital centers, determined the baseline clinical performances, reproducibility, and nAb level correlations of 10 commercially available immunoassays. In addition, three lateral-flow chromatography assays were evaluated, as these devices can be used in logistically challenged areas. All assays were evaluated using the same patient panels in duplicate, thus enabling accurate comparison of the tests. Seven immunoassays examined in this study were shown to have excellent specificity (98 to 100%) and good to excellent positive predictive values (82 to 100%) when used in a low (5%)-seroprevalence setting. We observed sensitivities as low as 74% and as high as 95% at ≥15 days after symptom onset. The determination of optimized cutoff values through receiver operating characteristic (ROC) curve analyses had a significant impact on the diagnostic resolution of several enzyme immunoassays by increasing the sensitivity significantly without a large trade-off in specificity. We found that spike-based immunoassays seem to be better correlates of nAb activity. Finally, the results reported here will add to the general knowledge of the interlaboratory reproducibility of clinical performance parameters of immunoassays and provide new evidence about nAb activity prediction.

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          Most cited references 36

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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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            SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor

            Summary The recent emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) in China and its rapid national and international spread pose a global health emergency. Cell entry of coronaviruses depends on binding of the viral spike (S) proteins to cellular receptors and on S protein priming by host cell proteases. Unravelling which cellular factors are used by SARS-CoV-2 for entry might provide insights into viral transmission and reveal therapeutic targets. Here, we demonstrate that SARS-CoV-2 uses the SARS-CoV receptor ACE2 for entry and the serine protease TMPRSS2 for S protein priming. A TMPRSS2 inhibitor approved for clinical use blocked entry and might constitute a treatment option. Finally, we show that the sera from convalescent SARS patients cross-neutralized SARS-2-S-driven entry. Our results reveal important commonalities between SARS-CoV-2 and SARS-CoV infection and identify a potential target for antiviral intervention.
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              A new coronavirus associated with human respiratory disease in China

               Fan Wu,  Su Zhao,  Bin Yu (2020)
              Emerging infectious diseases, such as severe acute respiratory syndrome (SARS) and Zika virus disease, present a major threat to public health 1–3 . Despite intense research efforts, how, when and where new diseases appear are still a source of considerable uncertainty. A severe respiratory disease was recently reported in Wuhan, Hubei province, China. As of 25 January 2020, at least 1,975 cases had been reported since the first patient was hospitalized on 12 December 2019. Epidemiological investigations have suggested that the outbreak was associated with a seafood market in Wuhan. Here we study a single patient who was a worker at the market and who was admitted to the Central Hospital of Wuhan on 26 December 2019 while experiencing a severe respiratory syndrome that included fever, dizziness and a cough. Metagenomic RNA sequencing 4 of a sample of bronchoalveolar lavage fluid from the patient identified a new RNA virus strain from the family Coronaviridae, which is designated here ‘WH-Human 1’ coronavirus (and has also been referred to as ‘2019-nCoV’). Phylogenetic analysis of the complete viral genome (29,903 nucleotides) revealed that the virus was most closely related (89.1% nucleotide similarity) to a group of SARS-like coronaviruses (genus Betacoronavirus, subgenus Sarbecovirus) that had previously been found in bats in China 5 . This outbreak highlights the ongoing ability of viral spill-over from animals to cause severe disease in humans.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                J Clin Microbiol
                J Clin Microbiol
                jcm
                jcm
                JCM
                Journal of Clinical Microbiology
                American Society for Microbiology (1752 N St., N.W., Washington, DC )
                0095-1137
                1098-660X
                10 December 2020
                18 February 2021
                March 2021
                18 February 2021
                : 59
                : 3
                Affiliations
                [a ]Laboratoire de Santé Publique du Québec, Institut Nationale de Santé Publique, Sainte-Anne-de-Bellevue, Québec, Canada
                [b ]Centre Hospitalier Universitaire Sainte-Justine, Montreal, Québec, Canada
                [c ]Centre Hospitalier Universitaire de Québec, Québec, Québec, Canada
                [d ]Hôpital Cité de la Santé, Laval, Québec, Canada
                [e ]Centre Hospitalier Affilié Universitaire Régional, Trois-Rivières, Québec, Canada
                [f ]Centre Hospitalier Régional de Rimouski, Rimouski, Québec, Canada
                [g ]Centre Universitaire de Santé McGill, Montreal, Québec, Canada
                [h ]Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada
                [i ]Héma-Québec, Québec, Québec, Canada
                [j ]Hôpital de Chicoutimi, Chicoutimi, Québec, Canada
                [k ]Département de Microbiologie, Infectiologie, Immunologie, Université de Montréal, Montreal, Québec, Canada
                [l ]Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
                [m ]Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
                [n ]Hôpital de Lévis, Lévis, Québec, Canada
                [o ]Hôpital Sacré-Cœur de Montréal, Montreal, Québec, Canada
                Cepheid
                Author notes
                Address correspondence to C. Therrien, christian.therrien@ 123456inspq.qc.ca .

                Citation Therrien C, Serhir B, Bélanger-Collard M, Skrzypczak J, Shank DK, Renaud C, Girouard J, Loungnarath V, Carrier M, Brochu G, Tourangeau F, Gilfix B, Piche A, Bazin R, Guérin R, Lavoie M, Martel-Laferrière V, Fortin C, Benoit A, Marcoux D, Gauthier N, Laumaea AM, Gasser R, Finzi A, Roger M. 2021. Multicenter evaluation of the clinical performance and the neutralizing antibody activity prediction properties of 10 high-throughput serological assays used in clinical laboratories. J Clin Microbiol 59:e02511-20. https://doi.org/10.1128/JCM.02511-20.

                Article
                02511-20
                10.1128/JCM.02511-20
                8106733
                33303562
                Copyright © 2021 American Society for Microbiology.

                All Rights Reserved.

                This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                Page count
                Figures: 3, Tables: 6, Equations: 0, References: 35, Pages: 16, Words: 9562
                Product
                Funding
                Funded by: Fonds de Recherche du Québec - Santé (FRQS), https://doi.org/10.13039/501100000156;
                Award Recipient : Valérie Martel-Laferrière
                Funded by: Mitacs, https://doi.org/10.13039/501100004489;
                Award Recipient :
                Categories
                Immunoassays
                Custom metadata
                March 2021
                free

                Microbiology & Virology

                covid-19, sars-cov-2, antigen, immunoassays, neutralizing antibodies, serology

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