TY - JOUR
T1 - Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications
AU - Stone, Mars
AU - Grebe, Eduard
AU - Sulaeman, Hasan
AU - Di Germanio, Clara
AU - Dave, Honey
AU - Kelly, Kathleen
AU - Biggerstaff, Brad J.
AU - Crews, Bridgit O.
AU - Tran, Nam
AU - Jerome, Keith R.
AU - Denny, Thomas N.
AU - Hogema, Boris
AU - Destree, Mark
AU - Jones, Jefferson M.
AU - Thornburg, Natalie
AU - Simmons, Graham
AU - Krajden, Mel
AU - Kleinman, Steve
AU - Dumont, Larry J.
AU - Busch, Michael P.
N1 - Publisher Copyright:
© 2022 Centers for Disease Control and Prevention (CDC). All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - 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.
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; 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.
UR - http://www.scopus.com/inward/record.url?scp=85125205291&partnerID=8YFLogxK
U2 - 10.3201/eid2803.211885
DO - 10.3201/eid2803.211885
M3 - Article
C2 - 35202525
AN - SCOPUS:85125205291
SN - 1080-6040
VL - 28
SP - 672
EP - 683
JO - Emerging Infectious Diseases
JF - Emerging Infectious Diseases
IS - 3
ER -