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Head-to-head evaluation of seven different seroassays including direct viral neutralisation in a representative cohort for SARS-CoV-2.
Olbrich, Laura; Castelletti, Noemi; Schälte, Yannik; Garí, Mercè; Pütz, Peter; Bakuli, Abhishek; Pritsch, Michael; Kroidl, Inge; Saathoff, Elmar; Guggenbuehl Noller, Jessica Michelle; Fingerle, Volker; Le Gleut, Ronan; Gilberg, Leonard; Brand, Isabel; Falk, Philine; Markgraf, Alisa; Deák, Flora; Riess, Friedrich; Diefenbach, Max; Eser, Tabea; Weinauer, Franz; Martin, Silke; Quenzel, Ernst-Markus; Becker, Marc; Durner, Jürgen; Girl, Philipp; Müller, Katharina; Radon, Katja; Fuchs, Christiane; Wölfel, Roman; Hasenauer, Jan; Hoelscher, Michael; Wieser, Andreas.
  • Olbrich L; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Castelletti N; German Center for Infection Research (DZIF), Partner site Munich, Germany.
  • Schälte Y; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Garí M; Institute of Radiation Medicine, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Pütz P; Institute of Computational Biology, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Bakuli A; Center for Mathematics, Technische Universität München, 85748 Garching, Germany.
  • Pritsch M; Institute of Computational Biology, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Kroidl I; Institute of Computational Biology, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Saathoff E; Department of Business Administration and Economics, Bielefeld University, 33615 Bielefeld, Germany.
  • Guggenbuehl Noller JM; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Fingerle V; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Le Gleut R; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Gilberg L; German Center for Infection Research (DZIF), Partner site Munich, Germany.
  • Brand I; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Falk P; German Center for Infection Research (DZIF), Partner site Munich, Germany.
  • Markgraf A; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Deák F; German Center for Infection Research (DZIF), Partner site Munich, Germany.
  • Riess F; Bavarian Health and Food Safety Authority (LGL), Germany.
  • Diefenbach M; Institute of Computational Biology, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Eser T; Core Facility Statistical Consulting, Helmholtz Zentrum München, 85764 Neuherberg, Germany.
  • Weinauer F; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Martin S; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Quenzel EM; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Becker M; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Durner J; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Girl P; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Müller K; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Radon K; Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.
  • Fuchs C; BRK-Blutspendedienst, 80336 Munich, Germany.
  • Wölfel R; BRK-Blutspendedienst, 80336 Munich, Germany.
  • Hasenauer J; BRK-Blutspendedienst, 80336 Munich, Germany.
  • Hoelscher M; Department of Conservative Dentistry and Periodontology, University Hospital, LMU Munich Ludwig-Maximilians-University of Munich, Goethestr. 70, 80336 Munich, Germany.
  • Wieser A; Laboratory Becker and colleagues, Führichstr. 70, 81671 München, Germany.
  • On Behalf Of The KoCo-Study Group; Department of Conservative Dentistry and Periodontology, University Hospital, LMU Munich Ludwig-Maximilians-University of Munich, Goethestr. 70, 80336 Munich, Germany.
J Gen Virol ; 102(10)2021 10.
Article in English | MEDLINE | ID: covidwho-1488154
ABSTRACT
A number of seroassays are available for SARS-CoV-2 testing; yet, head-to-head evaluations of different testing principles are limited, especially using raw values rather than categorical data. In addition, identifying correlates of protection is of utmost importance, and comparisons of available testing systems with functional assays, such as direct viral neutralisation, are needed.We analysed 6658 samples consisting of true-positives (n=193), true-negatives (n=1091), and specimens of unknown status (n=5374). For primary testing, we used Euroimmun-Anti-SARS-CoV-2-ELISA-IgA/IgG and Roche-Elecsys-Anti-SARS-CoV-2. Subsequently virus-neutralisation, GeneScriptcPass, VIRAMED-SARS-CoV-2-ViraChip, and Mikrogen-recomLine-SARS-CoV-2-IgG were applied for confirmatory testing. Statistical modelling generated optimised assay cut-off thresholds. Sensitivity of Euroimmun-anti-S1-IgA was 64.8%, specificity 93.3% (manufacturer's cut-off); for Euroimmun-anti-S1-IgG, sensitivity was 77.2/79.8% (manufacturer's/optimised cut-offs), specificity 98.0/97.8%; Roche-anti-N sensitivity was 85.5/88.6%, specificity 99.8/99.7%. In true-positives, mean and median Euroimmun-anti-S1-IgA and -IgG titres decreased 30/90 days after RT-PCR-positivity, Roche-anti-N titres decreased significantly later. Virus-neutralisation was 80.6% sensitive, 100.0% specific (≥15 dilution). Neutralisation surrogate tests (GeneScriptcPass, Mikrogen-recomLine-RBD) were >94.9% sensitive and >98.1% specific. Optimised cut-offs improved test performances of several tests. Confirmatory testing with virus-neutralisation might be complemented with GeneScriptcPassTM or recomLine-RBD for certain applications. Head-to-head comparisons given here aim to contribute to the refinement of testing strategies for individual and public health use.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Neutralization Tests / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Etiology study / Evaluation study / Incidence study / Observational study / Prognostic study / Risk factors Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: Jgv.0.001653

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Neutralization Tests / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Etiology study / Evaluation study / Incidence study / Observational study / Prognostic study / Risk factors Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: Jgv.0.001653