TABLE 2.

Summary of molecular diagnostic tests for SARS‐CoV‐2 (EUAs)

Detection target	Collected samples	Limit of detection (LoD)	Manufacturer	Detection principle	Diagnostic	Source
ORF1ab, E gene	individual or pooled nasal, nasopharyngeal, and oropharyngeal swab samples	Target 1 (SARS‐CoV‐2): 25 copies/ml (95% CI: 17–58 copies/ml) Target 2 (pan‐Sarbecovirus): 32 copies/ml (95% CI: 21–73 copies/ml)	Roche Molecular Systems, Inc. (RMS)	Real‐time RT‐PCR	Cobas SARS‐CoV‐2	126
ORF1ab and N gene	upper respiratory tract specimens	1 copy/μl	SEASUN BIOMATERIALS, Inc.	RT‐LAMP	AQ‐TOP COVID‐19 Rapid Detection Kit PLUS	127
	upper respiratory and BAL specimens	150 copies/ml	Euroimmun US, Inc.	Real‐time RT‐PCR	EURORealTime SARS‐Cov‐2	128
N gene, RNase P gene	nasopharyngeal, anterior nasal, mid‐turbinate, oropharyngeal swab specimens, nasopharyngeal wash/aspirate, and nasal aspirate specimens	640 GC/ml (Determination of SARS‐CoV‐2 heat‐inactivated virus) 40 GE/ml (Detection of quantified genomic viral RNA from SARS‐CoV‐2)	Becton, Dickinson and Company (BD)	Real‐time RT‐PCR	BD SARS‐CoV‐2 Reagents for BD MAX System	129
	nasopharyngeal swab, oropharyngeal swab, mid‐turbinate nasal swab, and anterior nasal swab specimens	0.125 copies/μl	Fluidigm Corporation	Real‐time RT‐PCR	Advanta Dx COVID‐19 EASE assay	130
	upper respiratory specimens	20 copies/μl	Mammoth Biosciences, Inc.	RT‐LAMP, CRISPR/Cas12	SARS‐CoV‐2 DETECTR Reagent Kit	131
	anterior nares specimens	250 copies/swab	LGC, Biosearch Technologies	End‐Point RT‐PCR	Biosearch Technologies SARS‐CoV‐2 ultra‐high‐throughput End‐Point RT‐PCR Test	132
	upper respiratory specimens	1.2 copies/μl	Exact Sciences Laboratories	Real‐time RT‐PCR	SARS‐CoV‐2 (N gene detection) Test	133
	anterior nasal swab specimens	6.25 copies/μl	Premier Medical Laboratory Services	Real‐time RT‐PCR	PMLS SARS‐CoV‐2 Assay	134
	nasopharyngeal and oropharyngeal swab specimens	1 copy/μl	Avellino Lab USA, Inc.	Real‐time RT‐PCR	AvellinoCoV2 test	135
OFR1ab, N gene, RNase P gene	nasopharyngeal swabs, and anterior or mid‐turbinate nasal swabs	Nasopharyngeal swab: 75 GCE/ml of sample Anterior nasal swab: 75 GCE/ml of sample	Thermo Fisher Scientific Inc.	Real‐time RT‐PCR	TaqPath COVID‐19 RNase P Combo Kit 2.0	136
	upper respiratory tract specimens and bronchoalveolar lavage specimens	ORF1ab target: 6.75 cp/μl VTM N target: 1.35 cp/μl VTM	Sherlock BioSciences, Inc.	Sherlock,RT‐LAMP, CRISPR	Sherlock CRISPR SARS‐CoV‐2 Kit	137
N and E gene	nasopharyngeal (NP), oropharyngeal (OP), mid‐turbinate (MT), and anterior nares (nasal) swabs	75 copies/μl	MobileDetect Bio Inc.	RT‐LAMP	MobileDetect Bio BCC19 (MD‐Bio BCC19) Test Kit	138
	upper respiratory specimens	0.0200 PFU/ml	Cepheid	Real‐time RT‐PCR	Xpert Xpress SARS‐CoV‐2 test	139
	saliva specimens	6400 GE/ml	MicroGEM U.S., Inc.	Real‐time RT‐PCR	MicroGEM Sal6830 SARS‐CoV‐2 Saliva Test	140
N gene	upper respiratory tract specimens	20 copies/μl	UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin	RT‐LAMP, CRISPR/Cas12	SARS‐CoV‐2 RNA DETECTR Assay	141
	nasopharyngeal, anterior nasal, mid‐turbinate nasal, or oropharyngeal swab specimens	100 copies/ml (nasopharyngeal matrix)	Mammoth Biosciences, Inc	RT‐LAMP, CRISPR	DETECTR BOOST SARS‐CoV‐2 Reagent Kit	142
ORF1ab	anterior nasal swab samples	800 copies/ml	Detect, Inc.	LAMP, Lateral Flow Strips	Detect Covid‐19 Test	143
RdRP, E, and N genes	nasopharyngeal (NP), oropharyngeal (OP), bronchoalveolar lavage (BAL) specimens	140 copies/ml	PlexBio Co., Ltd.	RT‐PCR	IntelliPlex SARS‐CoV‐2 Detection Kit	144
N, ORF1ab, S gene, RNase P RNA (and DNA)	anterior nasal swab specimens	1 copy/μl	UCSD BCG EXCITE Lab	Real‐time RT‐PCR	UCSD EXCITE COVID‐19 EL Test	145