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Evaluation of commercially available high-throughput SARS-CoV-2 serological assays for serosurveillance and related applications
Mars Stone; Eduard Grebe; Hasan Sulaeman; Clara Di Germanio; Honey Dave; Kathleen Kelly; Brad Biggerstaff; Brigit O Crews; Nam Tran; Keith Jerome; Thomas N Denny; Boris Hogema; Mark Destree; Jefferson M Jones; Natalie Thornburg; Graham Simmons; Mel Krajden; Steven Kleinman; Larry J Dumont; Michael Paul Busch.
Affiliation
  • Mars Stone; Vitalant Research Institiute
  • Eduard Grebe; Vitalant Research Institute
  • Hasan Sulaeman; Vitalant Research Institute
  • Clara Di Germanio; Vitalant Research Institute
  • Honey Dave; Vitalant Research Institute
  • Kathleen Kelly; Vitalant Research Institute
  • Brad Biggerstaff; Centers for Disease Control and Prevention
  • Brigit O Crews; University of California Irvine Medical Center
  • Nam Tran; Department of Pathology and Laboratory Medicine University of California, Davis
  • Keith Jerome; University of Washington
  • Thomas N Denny; Duke University
  • Boris Hogema; Department of Blood-Borne Infections, Sanquin Research
  • Mark Destree; BloodWorks NorthWest
  • Jefferson M Jones; Centers for Disease Control and Prevention
  • Natalie Thornburg; Centers for Disease Control and Prevention
  • Graham Simmons; Vitalant Research Institute
  • Mel Krajden; British Columbia Centre for Disease Control
  • Steven Kleinman; Department of Pathology and Laboratory Medicine, University of British Columbia
  • Larry J Dumont; Vitalant Research Institute
  • Michael Paul Busch; VITALANT RESEARCH INSTITUTE
Preprint in English | medRxiv | ID: ppmedrxiv-21262414
ABSTRACT
SARS-CoV-2 serosurveys can estimate cumulative incidence for monitoring epidemics but require characterization of employed serological assays performance to inform testing algorithm development and interpretation of results. We conducted a multi-laboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serological assays using blinded panels of 1,000 highly-characterized blood-donor specimens. Assays demonstrated a range of sensitivities (96%-63%), specificities (99%-96%) and precision (IIC 0.55-0.99). Durability of antibody detection in longitudinal samples was dependent on assay format and immunoglobulin target, with anti-spike, direct, or total Ig assays demonstrating more stable, or increasing reactivity over time than anti-nucleocapsid, indirect, or IgG assays. Assays with high sensitivity, specificity and durable antibody detection are ideal for serosurveillance. Less sensitive assays demonstrating waning reactivity are appropriate for other applications, including characterizing antibody responses after infection and vaccination, and detection of anamnestic boosting by reinfections and vaccine breakthrough infections. Assay performance must be evaluated in the context of the intended use.
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study / Experimental_studies / Observational study / Prognostic study Language: English Year: 2021 Document type: Preprint
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study / Experimental_studies / Observational study / Prognostic study Language: English Year: 2021 Document type: Preprint