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Longitudinal evaluation of laboratory-based serological assays for SARS-CoV-2 antibody detection.
Bond, K A; Williams, E; Nicholson, S; Lim, S; Johnson, D; Cox, B; Putland, M; Gardiner, E; Tippett, E; Graham, M; Mordant, F; Catton, M; Lewin, S R; Subbarao, K; Howden, B P; Williamson, D A.
  • Bond KA; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia. Elec
  • Williams E; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
  • Nicholson S; Victorian Infectious Diseases Reference Laboratory at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
  • Lim S; Department of General Medicine and Infectious Diseases, Royal Melbourne Hospital, Melbourne, Vic, Australia; Department of General Medicine, The University of Melbourne, Vic, Australia.
  • Johnson D; Department of General Medicine and Infectious Diseases, Royal Melbourne Hospital, Melbourne, Vic, Australia; Department of General Medicine, The University of Melbourne, Vic, Australia.
  • Cox B; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of General Medicine and Infectious Diseases, Royal Melbourne Hospital, Melbourne, Vic, Australia.
  • Putland M; Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Vic, Australia.
  • Gardiner E; Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Vic, Australia.
  • Tippett E; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of General Medicine and Infectious Diseases, Royal Melbourne Hospital, Melbourne, Vic, Australia.
  • Graham M; Department of Microbiology and Infectious Diseases, Monash Health, Vic, Australia; The Peter Doherty Institute for Infection and Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Vic, Australia.
  • Mordant F; WHO Collaborating Centre for Reference and Research on Influenza at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
  • Catton M; Victorian Infectious Diseases Reference Laboratory at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.
  • Lewin SR; The Peter Doherty Institute for Infection and Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Vic, Australia; Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic, Australia.
  • Subbarao K; Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; WHO Collaborating Centre for Reference and Research on Influenza at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Aus
  • Howden BP; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; The
  • Williamson DA; Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; The
Pathology ; 53(6): 773-779, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1366648
ABSTRACT
Serological assays for SARS-CoV-2 infection are now widely available for use in diagnostic laboratories. Limited data are available on the performance characteristics in different settings, and at time periods remote from the initial infection. Validation of the Abbott (Architect SARS-CoV-2 IgG), DiaSorin (Liaison SARS-CoV-2 S1/S2 IgG) and Roche (Cobas Elecsys Anti-SARS-CoV-2) assays was undertaken utilising 217 serum samples from 131 participants up to 7 months following COVID-19 infection. The Abbott and DiaSorin assays were implemented into routine laboratory workflow, with outcomes reported for 2764 clinical specimens. Sensitivity and specificity were concordant with the range reported by the manufacturers for all assays. Sensitivity across the convalescent period was highest for the Roche at 95.2-100% (95% CI 81.0-100%), then the DiaSorin at 88.1-100% (95% CI 76.0-100%), followed by the Abbott 68.2-100% (95% CI 53.4-100%). Sensitivity of the Abbott assay fell from approximately 5 months; on this assay paired serum samples for 45 participants showed a significant drop in the signal-to-cut-off ratio and 10 sero-reversion events. When used in clinical practice, all samples testing positive by both DiaSorin and Abbott assays were confirmed as true positive results. In this low prevalence setting, despite high laboratory specificity, the positive predictive value of a single positive assay was low. Comprehensive validation of serological assays is necessary to determine the optimal assay for each diagnostic setting. In this low prevalence setting we found implementation of two assays with different antibody targets maximised sensitivity and specificity, with confirmatory testing necessary for any sample which was positive in only one assay.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal: Pathology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal: Pathology Year: 2021 Document Type: Article