Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications
, Eduard Grebe1
, 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, and Michael P. Busch
Author affiliations: Vitalant Research Institute, San Francisco, California, USA (M. Stone, E. Grebe, H. Sulaeman, C. Di Germanio, H. Dave, K. Kelly, G. Simmons, L.J. Dumont, M.P. Busch); University of California–San Francisco, San Francisco (M. Stone, E. Grebe, G. Simmons, M.P. Busch); South African Centre for Epidemiological Modelling and Analysis, Stellenbosch University, Stellenbosch, South Africa (E. Grebe); Centers for Disease Control and Prevention, Fort Collins, Colorado, USA (B.J. Biggerstaff); University of California Irvine Medical Center, Orange, California, USA (B.O. Crews); University of California–Davis, Davis, California, USA (N. Tran); Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, USA (K.R. Jerome); Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA (T.N. Denny); Sanquin Research, Amsterdam, the Netherlands (B. Hogema); BloodWorks NorthWest, Seattle (M. Destree); Centers for Disease Control and Prevention, Atlanta, Georgia, USA (J.M. Jones, N. Thornburg); British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada (M. Krajden); University of British Columbia, Vancouver (S. Kleinman); University of Colorado School of Medicine, Denver, Colorado, USA (L.J. Dumont)
Figure 1. Sensitivity of severe acute respiratory syndrome coronavirus 2 serologic assays (descriptions in Table 1) using 3 definitions of a true positive in study of commercially available high-throughput assays for serosurveillance. A) Positivity defined by qualification as CCP, coronavirus disease convalescent plasma donor (excluding purposely selected serosilent specimens). B) Positivity defined by neutralizing activity measured by Broad plaque reduction neutralization test. C) Positivity defined by operational standard (>3 binding antibody assays reactive). Dots indicate point estimates, and bars indicate Wilson score 95% CIs. Ortho VITROS IgG S assay is included only in panel B because the assay required use of serum for testing; thus, only specimens with available serum and neutralizing data were tested. Ab, antibody; Ag, antigen; N, nucleocapsid; RBD, receptor binding domain; PRNT, plaque reduction neutralization test; S, spike protein.
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Page updated: February 21, 2022
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