Table 4.

A list of exemplary diagnostic serologic assays currently used for SARS-CoV-2 (90).

Type	Target	Author/company, country	Sensitivity	Specificity	Date of release	Phase of development
Rapid diagnostic test	Solid phase immuno-chromatographic assay for IgG/IgM from blood or plasma	Aytu Biosciences/Orient Gene Biotech USA/China	87.9% IgG 97.2% IgM	100%	10-Mar	CE approved, awaiting FDA approval
	Lateral flow assay detecting IgG and IgM to the nucleocapside protein	Cellex Inc. USA	93.8%	95.6%	01-Apr	FDA approved
	Human venous whole blood, plasma from anticoagulated blood, or serum to detect IgG and IgM antibodies	Healgen Scientific LLC USA/China	96.7% IgG 86.7% IgM	98% IgG 99% IgM	01-Jun	FDA approved
	The target antigen is recombinant spike protein receptor binding domain	Hangzhou Biotest Biotech Co., Ltd China	91.6% IgG 92.5% IgM	99.5% IgG 98.1% IgM	04-Jun	FDA approved
Neutralization assay	A use of pseudovirus expressing the RBD of the spike protein to assay the ability of antibodies to block virus interaction with ACE2 receptors.	Genscript USA	93.0%	100	26-May	Research use only, CE approval
	SARS-CoV-2 and SARS-CoV-1 infection rate quantified using firefly luciferase reporter assay	Suhandynata et al. USA	96.6%	98.8	11-Jul	Pre-clinical
ELISA	Detects IgG specific to recombinant spike protein subunits 1 and 2 (S1 and S2)	DiaSorin Inc. USA	90.0–97.0%	98.0%	24-Apr	FDA approved
	Target antigen is recombinant nucleocapsid protein	Bio-Rad USA	98.0%	99.0%	29-Apr	EUA
	Target protein is a viral S1 region of the spike protein	Euroimmun AG Germany	0–10 days 13.9% 11–20 days 61.1% >21d 100%	100%	04-May	EUA
	Target antigen not stated	InBios International, Inc. USA	92.5%	98.5%	30-Jun	EUA

^*EUA, Emergency Use Authorization.