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Volume 28, Number 3—March 2022

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

Mars Stone1Comments to Author , 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)

Main Article

Table 2

Composition of the assessment panel for evaluation of SARS-CoV-2 serologic assays in study of commercially available high-throughput SARS-CoV-2 assays for serosurveillance*

Group Description No. specimens
Sensitivity subpanels
Qualification as CCP 191 CCP 191
Broad neutralization activity 152 CCP + 2 serosilent 154
Reactive on >3 assays
186 CCP + 2 serosilent
Specificity subpanel
Prepandemic blood donor specimens collected before 2020 and demonstrated to be anti–SARS-CoV-2 negative by RVP neutralization testing
Ab persistence subpanel
Longitudinal specimens from 24 donors with at >4 CCP donations 84–150 d after index donation
Seroconversion subpanel
Longitudinal specimens from a single-source plasma donor with acute SARS-CoV-2 infection
Dilutional performance subpanel
Serial dilutions of 5 specimens from sensitivity subpanel; neat (6 replicates), 1:40, 1:80, 1:160, 1:320, and 1:640 analogous to neutralizing antibody testing
Serosilent cases
Individual CCP donors nonreactive by S and N anti–SARS-CoV-2 total Ig
Repeatability subpanel Six blinded replicates each of 15 CCP specimens 90

*CCP, coronavirus disease convalescent plasma; N, nucleocapsid; RBD, receptor binding domain; RVP, reporter viral particle; S, spike protein; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

Main Article

1These first authors contributed equally to this article.

Page created: January 12, 2022
Page updated: February 21, 2022
Page reviewed: February 21, 2022
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