TY - JOUR AU - Stone, Mars AU - Grebe, Eduard AU - Sulaeman, Hasan AU - Di Germanio, Clara AU - Dave, Honey AU - Kelly, Kathleen AU - Biggerstaff, Brad AU - Crews, Bridgit AU - Tran, Nam AU - Jerome, Keith AU - Denny, Thomas AU - Hogema, Boris AU - Destree, Mark AU - Jones, Jefferson AU - Thornburg, Natalie AU - Simmons, Graham AU - Krajden, Mel AU - Kleinman, Steve AU - Dumont, Larry AU - Busch, Michael T1 - Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications T2 - Emerging Infectious Disease journal PY - 2022 VL - 28 IS - 3 SP - 672 SN - 1080-6059 AB - 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. KW - COVID-19 KW - coronavirus disease KW - SARS-CoV-2 KW - severe acute respiratory syndrome coronavirus 2 KW - viruses KW - respiratory infections KW - zoonoses KW - vaccine-preventable diseases KW - serologic assays DO - 10.3201/eid2803.211885 UR - https://wwwnc.cdc.gov/eid/article/28/3/21-1885_article ER - End of Reference