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.
【저자키워드】 COVID-19, coronavirus disease, severe acute respiratory syndrome coronavirus 2, viruses, respiratory infections, zoonoses, SARS-CoV-2, vaccine-preventable diseases, serologic assays, 【초록키워드】 severe acute respiratory syndrome coronavirus 2, IgG, coronavirus, vaccination, Epidemics, severe acute respiratory syndrome Coronavirus, Antigen, sensitivity, specificity, Neutralizing activity, Antibody detection, Serosurvey, Immunoglobulin, SARS-CoV-2 variants, Algorithm, Interpretation, circulation, incidence, respiratory, correlation, serologic assays, specimens, cumulative incidence, Intraclass correlation coefficient, acute respiratory syndrome, Precision, acute respiratory syndrome coronavirus, sensitivities, cumulative, Specificities, total Ig, widespread, serologic assay, blinded, assays, evaluated, conducted, characterized, dependent on, demonstrated, reactivity, 【제목키워드】 serologic, application,