TABLE 2.

FDA-Approved Gold Nanoparticle-based Serology Tests for SARS-CoV-2 under EUA Designation (as of January 17)^a

Diagnostic	Manufacturer	Antibody/Assay Format	Sample	Authorized Setting(s)b
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)	Healgen Scientific LLC	IgM and IgG, lateral Flow	Serum, plasma, and venous whole blood	H, M
qSARS-CoV-2 IgG/IgM Rapid Test	Cellex Inc.	IgM and IgG, lateral flow	Serum, plasma, and venipuncture whole blood	H, M
WANTAI SARS-CoV-2 Ab Rapid Test	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	Total Antibody, lateral flow	Serum, plasma, and venous whole blood	H, M
Rapid COVID-19 IgM/IgG Combo Test Kit	Megna Health, Inc.	IgM and IgG, lateral flow	Serum and plasma	H, M
Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test	Biocan Diagnostics	IgM and IgG, lateral flow	Serum, plasma, and venous whole blood	H, M
TBG SARS-CoV-2 IgG / IgM Rapid Test Kit	TBG Biotechnology	IgM and IgG, lateral flow	Serum and plasma	H, M
SGTi-flex COVID-19 IgG	Sugentech	IgG, lateral flow	serum, venous whole blood and plasma	H, M
Assure COVID-19 IgG/IgM Rapid Test Device	Assure Tech. (Hangzhou)	IgM and IgG, lateral flow	Serum, plasma, venous whole blood, and fingerstick whole blood	H, M, W
MosaiQ COVID-19 Antibody Magazine	Quotient Suisse SA	Total Antibody, photometric immunoassay	Serum and plasma	H
Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit	Nirmidas Biotech	IgM and IgG, lateral flow	Serum and plasma	H, M
Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit	Biohit Healthcare (Hefei)	IgM and IgG, lateral flow	Serum, plasma, and venipuncture whole blood	H, M
CareStart COVID-19 IgM/IgG	Access Bio	IgM and IgG, lateral flow	Serum, plasma, and venous whole blood	H, M
BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test	Xiamen Biotime Biotechnology	IgM and IgG, lateral flow	Serum, plasma, and venous whole blood	H, M
Jiangsu Well Biotech	Orawell IgM/IgG Rapid Test	IgM and IgG, lateral flow	Serum and plasma	H, M
Innovita 2019-nCoV Ab Test	Innovita (Tangshan) Biological Technology	IgM and IgG, lateral flow	Serum, plasma, and venous whole blood	H, M
RightSign COVID-19 IgG/IgM Rapid Test Cassette	Hangzhou Biotest Biotech	IgM and IgG, lateral flow	Serum, plasma, venous whole blood, and fingerstick whole blood	H, M, W
ACON SARS-CoV-2 IgG/IgM Rapid Test	ACON Laboratories	IgM and IgG, lateral flow	Serum, plasma, and venous whole blood	H, M
LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit	Hangzhou Laihe Biotech	IgM and IgG, lateral flow	Serum and plasma	H, M
MidaSpot COVID-19 Antibody Combo Detection Kit	Nirmidas Biotech	IgM and IgG, lateral flow	Fingerstick whole blood, serum and plasma	H, M, W
Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette	Salofa Oy	IgM and IgG, Lateral Flow	Fingerstick whole blood	H, M, W
RapCov Rapid COVID-19 Test	ADVAITE	IgG, Lateral Flow	Fingerstick whole blood	H, M, W

^aEUA: Emergency Use Authorization.

^bAuthorized settings include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.

• W - Patient care settings operating under a CLIA Certificate of Waiver.