Table 1

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

Mars Stone¹

, 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)

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Key characteristics of assays evaluated in study of commercially available high-throughput SARS-CoV-2 assays for serosurveillance*

Manufacturer	Assay†	Ig target	Antigen	Assay format	Reported units	Testing laboratory
Ortho	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Ig	Total Ig	S1	Double-antigen sandwich CLIA	S/CO	Vitalant Research Institute
Ortho	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG	IgG	S1	Double-antigen sandwich CLIA	S/CO	CTS
EUROIMMUN	Anti-SARS-CoV-2 NCP ELISA	IgG	N	Indirect IgG EIA	S/CO	Advent Health
	Anti-SARS-CoV-2 ELISA	IgG	S1	Antigen sandwich ELISA	S/CO
	Anti-SARS-CoV-2 QuantiVac ELISA	IgG	S1	Antigen sandwich ELISA	RU/mL
	Anti-SARS-CoV-2 ELISA	IgA	S1	Antigen sandwich ELISA	S/CO
Roche	Elecsys Anti-SARS-CoV-2 N on cobas	Total Ig	N	Double-antigen sandwich CLIA	COI	University of California–Davis
Roche	Elecsys Anti-SARS-CoV-2 S on cobas	Total Ig	S1/S2/RBD	Double-antigen sandwich CLIA	U/mL	University of California–Davis
DiaSorin	LIAISON 28 SARS-CoV-2 TrimericS IgG	IgG	TrimericS	IgG magnetic particle CLIA	AU/mL	British Columbia Centers for Disease Control and Prevention
Siemens	ADVIA Centaur SARS-CoV-2 Total Ig	Total Ig	S1/RBD	Ag sandwich CLIA	S/CO
Siemens	ADVIA Centaur SARS-CoV-2 IgG	IgG	S1/RBD	Ag sandwich CLIA	Index
Abbott	SARS-CoV-2 IgG N on ARCHITECT	IgG	N	CMIA	AU/mL	Duke Human Vaccine institute
	SARS-CoV-2 IgG S1 on ARCHITECT	IgG	S1	CMIA	S/CO	Duke Human Vaccine institute
	SARS-CoV-2 IgG N on Alinity	IgG	N	CMIA	S/CO	Fred Hutchinson Cancer Research Center
	SARS-CoV-2 IgG S1 on Alinity	IgG	S1	CMIA	AU/mL	Fred Hutchinson Cancer Research Center
Bio-Rad	Platelia SARS-CoV-2 Total Ab (Evolis)	Total Ig	N	One-step antigen capture	S/CO	BloodWorks NorthWest
Bio-Rad	BioPlex 2200 SARS-CoV-2 IgG Panel	IgG	RBD, S1, S2, N	Multiplexed microbeads two-step assay	S/CO
Quotient	MosaiQ COVID-19 Antibody Microarray	IgM/IgG	S1/S2	Array	Qualitative only
Diazyme	DZ-Lite SARS CoV-2	IgG	N & S1/S2	IgG microbead CLIA	S/CO
Beckman Coulter	Access SARS-CoV-2 IgG	IgG	S1 RBD	IgG 2-step paramagnetic particle CLIA	S/CO	University of California–Irvine
Wantai	SARS-CoV-2 Total Ig	Total Ig	S1 RBD	Total Ig sandwich ELISA	S/CO	Sanquin

*Ab, antibody; Ag, antigen; AU, arbitrary units; CMIA, chemiluminescent microparticle immunoassay; CLIA, chemiluminescent immunoassay;.COVID-19, coronavirus disease; EIA, enzyme immunoassay; Ig, immunoglobulin; N, nucleocapsid; RBD, receptor binding domain; RU, relative units; S, spike protein; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; S/CO, signal to cutoff ratio; †Current US regulatory status available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2.

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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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