Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications

Mars Stone, Eduard Grebe, Hasan Sulaeman, Clara Di Germanio, Honey Dave, Kathleen Kelly, Brad J. Biggerstaff, Bridgit O. Crews, Nam Tran, Keith R. Jerome, Thomas N. Denny, Boris Hogema, Mark Destree, Jefferson M. Jones, Natalie Thornburg, Graham Simmons, Mel Krajden, Steve Kleinman, Larry J. Dumont, Michael P. Busch

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serologic assays using blinded panels of 1,000 highly characterized specimens. Assays demonstrated a range of sensitivities (96%–63%), specificities (99%–96%), and precision (intraclass correlation coefficient 0.55–0.99). Durability of antibody detection was dependent on antigen and immunoglobulin targets; an-tispike and total Ig assays demonstrated more stable longitudinal reactivity than antinucleocapsid and IgG assays. Assays with high sensitivity, specificity, and durable antibody detection are ideal for serosurveillance, but assays demonstrating waning reactivity are appropriate for other applications, including correlation with neutralizing activity and detection of anamnestic boosting by reinfections. Assay performance must be evaluated in context of intended use, particularly in the context of widespread vaccination and circulation of SARS-CoV-2 variants.

Original languageEnglish (US)
Pages (from-to)672-683
Number of pages12
JournalEmerging infectious diseases
Volume28
Issue number3
DOIs
StatePublished - Mar 2022

ASJC Scopus subject areas

  • Epidemiology
  • Microbiology (medical)
  • Infectious Diseases

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