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

Publisher: National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC) Country of Publication: United States NLM ID: 9508155 Publication Model: Print Cited Medium: Internet ISSN: 1080-6059 (Electronic) Linking ISSN: 10806040 NLM ISO Abbreviation: Emerg Infect Dis Subsets: MEDLINE

Original Publication: Atlanta, GA : National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), [1995-

COVID-19*/diagnosis ; COVID-19*/epidemiology ; SARS-CoV-2*; Antibodies, Viral ; Humans ; Sensitivity and Specificity ; Serologic Tests/methods

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; antispike 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.

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Keywords: COVID-19; SARS-CoV-2; coronavirus disease; respiratory infections; serologic assays; severe acute respiratory syndrome coronavirus 2; vaccine-preventable diseases; viruses; zoonoses

0 (Antibodies, Viral)

SARS-CoV-2 variants

Date Created: 20220224 Date Completed: 20220301 Latest Revision: 20220304

20250114

PMC8888213

10.3201/eid2803.211885

35202525