Examples of commercial molecular diagnostic assays for the detection of SARS-CoV-2^a.

Manufacturer	Test name	Method	Target gene	Specimen type	LODb	Sensitivity	Specificity	Statusc	Ref.
LumiraDx UK Ltd	LumiraDx SARS-CoV-2 RNA STAR Complete	RT, qSTAR amplification, home collection, screening, pooling	N gene	Nasal swabs	32 TCID50 per mL	97%	96%	H	36
Abbott Molecular Inc.	Abbott RealTime SARS-CoV-2 Assay	RT-PCR	N and RdRP genes	Nasopharyngeal and oropharyngeal swabs	100 copies per mL	95.9%	100%	H	37
Meridian Bioscience, Inc.	Revogene SARS-CoV-2	RT-PCR	N gene	Nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens	7 TCID50 per mL	97.7%	97.7%	H, M	15
Talis Biomedical Corporation	Talis One COVID-19 Test System	Reverse transcriptase isothermal amplification	ORF1ab gene, N gene	Nasal mid-turbinate swabs	500 copies per mL	100%	100%	H, M, W	38
Cepheid	Xpert Xpress CoV-2/Flu/RSV plus	rRT-PCR	N gene, E gene, RdRP genes	Nasopharyngeal swabs, anterior nasal swabs, nasal wash/aspirate specimens	138 copies per mL	100%	100%	H, M, W	39
Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)	TaqPath COVID-19 Fast PCR Combo Kit 2.0	rRT-PCR	N gene, ORF1a, ORF1b	Saliva	1000 GCE per mL	97.1%	97.6%	H	40
Detect, Inc.	Detect Covid-19 Test	RT-LAMP	ORF1ab	Anterior nasal swabs	800 copies per mL	90.9%	97.5%	Home, H, M, W	41
PerkinElmer, Inc.	PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1	rRT-PCR	N gene, ORF1a gene	Nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs	SARS-CoV-2: 0.11 TCID50 per mL	100%	100%	H	20
LMSI, LLC (dba Lighthouse Lab Services)	CovidNow SARS-CoV-2 Assay	rRT-PCR	N gene	Upper respiratory specimens, self-collected anterior nasal swab specimens	800 copies per mL	96%	100%	H	21
Applied DNA Sciences Inc.	Linea COVID-19 Assay Kit	rRT-PCR	S gene (S1 and S2 regions)	Nasopharyngeal swabs and oropharyngeal swabs	1250 copies per mL	98%	92%	H	22
Enzo Life Sciences, Inc.	AMPIPROBE SARS-CoV-2 Test System	rRT-PCR	N gene and RdRP gene	Nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens	280 copies per mL	96.2%	98%	H	42
Thermo Fisher Scientific Inc.	TaqPath COVID-19 RNase P Combo Kit 2.0	rRT-PCR	N gene, ORF1a, ORF1b	Nasopharyngeal, anterior, and mid-turbinate nasal swabs	75 GCE per mL	96.7%	95%	H	43
Twist Bioscience Corporation	SARS-CoV-2 NGS Assay	NGS	Several	Nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs	800 copies per mL	96.7%	100%	H	44
BioGX, Inc.	BioGX Xfree COVID-19 Direct RT-PCR	rRT-PCR	N1 gene	Nasopharyngeal, anterior nasal, mid-turbinate	1000–3000 copies per mL (depending on the platform used)	95%	100%	H	26
OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit	rRT-PCR	RdRP, E gene, N gene	Alveolar lavage fluid, throat swab, sputum	10 copies per 20 μL reaction	100%	100%	H	45
OPTI Medical Systems	OPTI SARS-CoV-2 RT PCR Test	rRT-PCR, pooling	N gene (N1 and N2)	Anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs	700–900 copies per mL	100%	100%	H	46
PathogenDx, Inc.	DetectX-Rv	rRT-PCR, DNA microarray hybridization	N gene (N1 and N2 regions)	Nasopharyngeal swabs, oropharyngeal swabs, mid-turbinate swabs, anterior nasal swabs	1000 copies per mL	95%	100%	H	47
Hologic, Inc.	Aptima SARS-CoV-2 Assay	Real-time TMA, dual kinetic assay	ORF1ab (2 targets)	Nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens	212 copies per mL within a sample (83 copies per mL within the tested aliquot)	100%	98%	H	48
LumiraDx UK Ltd	LumiraDx SARS-CoV-2 RNA STAR Complete	RT-qSTAR amplification	ORF1a	Mid-turbinate, nasopharyngeal, and oropharyngeal swabs	7500 copies per mL	97.8%	98.5%	H	49
Quidel Corporation	Solana SARS-CoV-2 Assay	Molecular isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)	ORF1ab	Nasopharyngeal and nasal swab specimens	1.16 ×104 copies per mL	90.3%	97.8%	H, M	32
Cue Health Inc.	Cue COVID-19 Test for Home and Over the Counter Use	Isothermal amplification, home collection	N gene	Anterior nares swabs	2700 copies per mL	96% (symptomatic), (100% asymptomatic)	98% (symptomatic), (100% asymptomatic)	Home, H, M, W	50
Grifols Diagnostic Solutions Inc.	Procleix SARS-CoV-2 Assay	Transcription-mediated nucleic acid amplification (TMA)	Not stated	Anterior nasal and mid-turbinate nasal swabs, nasopharyngeal	60 copies per mL	100%	100%	H	51
Agena Bioscience, Inc.	MassARRAY SARS-CoV-2 Panel	rRT-PCR, MALDI-TOF	N gene (N1, N2, and N3 regions), ORF1, and ORF1ab	Nasopharyngeal swabs, oropharyngeal swabs, nasal and mid-turbinate swabs	310–2500 copies per mL	98.9%	100%	H	35
Cepheid	Xpert® Omni SARS-CoV-2	rRT-PCR	E gene and N gene (N2 region)	Nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab specimens	400 copies per mL	100%	100%	H, M, W	52
Lucira Health, Inc.	Lucira COVID-19 All-In-One Test Kit	RT-LAMP	N gene (two regions)	Nasal swab (self-collection), nasal swab (healthcare collection)	2700 copies per swab (or 900 copies per mL if the sample is 100% lysed and eluted)	94%	98%	Home, H, M, W	53
GenMark Diagnostics, Inc.	ePlex Respiratory Pathogen Panel 2	rRT-PCR, electrochemical detection	Not stated	Nasopharyngeal swabs	0.01TCID50 per mL	100%	100%	H, M	54
Seasun Biomaterials, Inc.	AQ-TOP COVID-19 Rapid Detection Kit PLUS	RT-LAMP	ORF1ab and N genes	Oropharyngeal and nasopharyngeal swabs, anterior nasal and mid-turbinate nasal swabs	1000 copies per mL	100%	100%	H	55
Clear Labs, Inc.	Clear Dx SARS-CoV-2 Test	rRT-PCR, NGS	Several	Nasopharyngeal swab, oropharyngeal swab, anterior nasal swab	2000 copies per mL	100%	100%	H	56
Abbott Diagnostics Scarborough	ID NOW COVID-19	Isothermal amplification	RdRP	Direct nasal secretions, nasopharyngeal or throat swabs	125 copies per mL	100%	100%	H, M, W	57
Cue Health Inc.	Cue COVID-19 Test	Isothermal amplification	N gene	Nasal swab	1300 copies per mL	100%	92%	Home, H, M, W	58

^aH: laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (chemiluminescence immunoassay, 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.

^bLOD, Limit of detection.

^cStatus, Authorized settings include the following.