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letter
. 2020 Apr 24;3:8. [Version 1] doi: 10.12688/aasopenres.13059.1

Table 1. Coronavirus disease 2019 (COVID-19) diagnostic tests that have currently received Emergency Use Authorizations (EUA) by the US Food and Drug Administration.

Date EUA
issued		 Manufacturer Diagnostic name Principle action
04/08/2020 DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit qRT-PCR for N, Orf1ab and E genes
04/08/2020 Becton, Dickinson & Company BD SARS-CoV-2Reagents for BD
MAX System		 Multiplex qRT-PCR for N1 and N2 regions,
and the human RNase P gene
04/07/2020 InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR
Kit		 Multiplex qRT-PCR for N, Orf1ab and E genes
04/06/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR
Detection Kit		 Real-time RT-digital PCR for N1 and N2
regions, and the human RNase P gene
04/03/2020 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease
2019 (COVID-19) Kit		 rRT-PCR for RdRp gene
04/03/2020 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus
Real-time RT-PCR (RT-qPCR) Detection Kit		 rRT-PCR for N and Human RPP30 genes
04/03/2020 Luminex Corporation ARIES SARS-CoV-2 Assay Multiplex qRT-PCR for ORF1ab, E gene, and N gene
04/02/2020 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD
MAX System		 Multiplexed qRT-PCR for N1 and RNase P
04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx assay Multiplexed qRT-PCR for N and RNase P
04/01/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test IgM and IgG antibodies against SARSCoV-2
03/30/2020 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2
Panel		 Multiplexed qRT-PCR for Orf1b poly gene
(Rdrp gene) and E gene
03/30/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay Multiplexed qRT-PCR for Nsp2 gene and N
gene
03/27/2020 Luminex Molecular Diagnostics,
Inc.		 NxTAG CoV Extended Panel Assay Multiplex qRT-PCR for ORF1ab, and E gene
03/27/2020 Abbott Diagnostics Scarborough,
Inc.		 ID NOW COVID-19 rRT-PCR for; RdRp gene
03/26/2020 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for
Detecting SARS-2019-nCoV		 Multiplex qRT-PCR for N gene, E gene, and
RdRp gene
03/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 test rRT-PCR for N gene
03/24/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic
Acid Detection Kit		 Multiplex qRT-PCR for ORF1ab and N genes
03/23/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test rRT-PCR for N gene
03/23/2020 BioFire Defense, LLC BioFire COVID-19 Test Nested multiplex real-time RT-PCR for
ORF1ab, ORF8
03/20/2020 Cepheid Xpert Xpress SARS-CoV-2 test Multiplex qRT-PCR for E and N2 genes
03/20/2020 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig
Real-Time PCR assay		 rRT-PCR for RdRp gene
03/19/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test rRT-PCR for N gene
03/19/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay Multiplex qRT-PCR for ORF1ab and S genes
03/18/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 assay Multiplex qRT-PCR for RdRp and N genes
03/17/2020 Quest Diagnostics Infectious
Disease, Inc.		 Quest SARS-CoV-2 rRT-PCR rRT-PCR for N gene (N1 and N3 genes)
03/17/2020 Quidel Corporation Lyra SARS-CoV-2 Assay rRT-PCR for ORF1ab
03/16/2020 Laboratory Corporation of America
(LabCorp)		 COVID-19 RT-PCR Test rRT-PCR for N gene
03/16/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 rRT-PCR for RdRp gene
03/13/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit Multiplex qRT-PCR for ORF1ab, N gene, S
gene, MS2
03/12/2020 Roche Molecular Systems, Inc.
(RMS)		 cobas SARS-CoV-2 Multiplex qRT-PCR for ORF-1a and E-gene
02/29/2020 Wadsworth Center, New York State
Department of Public Health's
(CDC)		 New York SARS-CoV-2 Real-time
Reverse Transcriptase (RT)-PCR
Diagnostic Panel		 rRT-PCR for N gene
02/04/2020 Centers for Disease Control and
Prevention's (CDC)		 CDC 2019-nCoV Real-Time RT-PCR
Diagnostic Panel (CDC)		 Multiplex qRT-PCR for N1, N2, and RP genes
of the virus