Table 4.

Comparison of molecular diagnostics for COVID-19 with FDA-EUA approval.

Manufacturer	Test	SARS-CoV-2 Biomarkers	Sample Types Accepted	Time to Result	Sensitivity/Specificity	References
CDC	2019-nCoVReal-Time RT-PCR Diagnostic Panel	N1, N2, RP	Nasopharyngeal (NP) swab, Oropharyngeal (OP) swab, Sputum, Tracheal aspirates, Bronchoalveolar lavage (BAL), Nasal aspirate	~80 min for 1 sample	100% (13/13)/100% (104/104)	https://www.internationalreagentresource.org/QuickLinks/COVID-19FAQ.aspx#Full%20List
QIAGEN	QIAstat-Dx\ RespiratorySARS-CoV-2 Panel	ORF1b, E	NP swab	~1 h for 1 sample	100% (30/30)/100% (30/30)	https://www.qiagen.com/us/products/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing/qiastat-dx-eua-us/#orderinginformation
PerkinElmer	PerkinElmer® New Coronavirus Nucleic Acid Detection Kit	ORF1ab and N	NP swab, OP swab	~2 h for 96 samples	2X LOD (100%, 20/20)4X LOD (100%, 20/20)/100% (94/94)	https://perkinelmer-appliedgenomics.com/home/products/new-coronavirus-2019-ncov-nucleic-acid-detection-kit/
Thermo Fisher Scientific	TaqPath COVID-19 Combo Kit	ORF1b, S, N	NP swab, BAL, Nasal swabs, OP swabs, Nasal aspirate,Mid-turbinate swabs	3 h for 94 samples	100% (60/60)/100% (60/60)	https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/pathogen-detection-solutions/taqpath-covid-19-diagnostic-kit.html
Roche	cobasSARS-CoV-2	ORF1a/b, E	NP swab, OP swab	3 h for 96 samples	100% (50/50)/100% (100/100)	https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-test.html
AbbottMolecular	Alinity m SARS-CoV-2 Assay	RdRp, N	NP swabs, OP swabs, BAL	~2 h for 24 samples	100% (40/40)/96.5% (55/57)	https://www.molecular.abbott/us/en/products/infectious-disease/alinity-m-sars-cov-2-assay
Becton, Dickinson & Company (BD)	BD SARS-CoV-2 Reagents for BD MAX System	N1, N2,	NP swab, OP swab	3 h for 24 samples	1-2X LOD (95%, 38/40)3-5X LOD (100%, 10/10); 100% (29/29)	https://www.bd.com/en-us/offerings/capabilities/molecular-diagnostics/molecular-tests/biogx-sars-cov-2-reagents