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Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay
Christian Irsara; Alexander E Egger; Wolfgang Prokop; Manfred Nairz; Lorin Loacker; Sabina Sahanic; Thomas Sonnweber; Wolfgang Mayer; Harald Schennach; Judith Loeffler-Ragg; Rosa Bellmann-Weiler; Ivan Tancevski; Guenter Weiss; Markus Anliker; Andrea Griesmacher; Gregor Hoermann.
Afiliación
  • Christian Irsara; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck, Innsbruck, Austria
  • Alexander E Egger; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck, Innsbruck, Austria
  • Wolfgang Prokop; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck, Innsbruck, Austria
  • Manfred Nairz; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Lorin Loacker; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Inns-bruck, Innsbruck, Austria
  • Sabina Sahanic; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Thomas Sonnweber; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Wolfgang Mayer; Central Institute for Blood Transfusion and Immunology (ZIB), University Hospital of Innsbruck, Innsbruck, Austria
  • Harald Schennach; Central Institute for Blood Transfusion and Immunology (ZIB), University Hospital of Innsbruck, Innsbruck, Austria
  • Judith Loeffler-Ragg; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Rosa Bellmann-Weiler; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Ivan Tancevski; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Guenter Weiss; Department of Internal Medicine II, Infectious Diseases, Pneumology, Rheumatology, Medical University of Innsbruck, Innsbruck, Austria
  • Markus Anliker; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Inns-bruck, Innsbruck, Austria
  • Andrea Griesmacher; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Inns-bruck, Innsbruck, Austria
  • Gregor Hoermann; Central Institute of Clinical and Chemical Laboratory Diagnostics, University Hospital of Inns-bruck, Innsbruck, Austria
Preprint en En | PREPRINT-MEDRXIV | ID: ppmedrxiv-20239590
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ABSTRACT
ObjectivesSerological tests detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the ongoing coronavirus disease-19 (COVID-19) pandemic. Independent external clinical validation of performance characteristics is of paramount importance. MethodsFour fully automated assays, Roche Elecsys Anti-SARS-CoV-2, Abbott SARS-CoV-2 IgG, Siemens SARS-CoV-2 total (COV2T) and SARS-CoV-2 IgG (COV2G) were evaluated using 350 pre-pandemic samples and 700 samples from 245 COVID-19 patients (158 hospitalized, 87 outpatients). ResultsAll tests showed very high diagnostic specificity. Sensitivities in samples collected at least 14 days after disease onset were slightly lower than manufacturers claims for Roche (93.04%), Abbott (90.83%), and Siemens COV2T (90.26%), and distinctly lower for Siemens COV2G (78.76%). Concordantly negative results were enriched for immunocompromised patients. ROC curve analyses suggest a lowering of the cut-off index for the Siemens COV2G assay. Finally, the combination of two anti-SARS-CoV-2 antibody assays is feasible when considering borderline reactive results. ConclusionsThorough on-site evaluation of commercially available serologic tests for detection of antibodies against SARS-CoV-2 remains imperative for laboratories. The potentially impaired sensitivity of the Siemens COV2G necessitates a switch to the companys newly filed SARS-CoV-2 IgG assay (sCOVG) for follow-up studies. A combination of tests could be considered in clinical practice.
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Cohort_studies / Diagnostic_studies / Experimental_studies / Prognostic_studies Idioma: En Año: 2020 Tipo del documento: Preprint
Texto completo
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Cohort_studies / Diagnostic_studies / Experimental_studies / Prognostic_studies Idioma: En Año: 2020 Tipo del documento: Preprint