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In Vitro Diagnostic COVID-19 Tests

In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to coronavirus diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health. The companies listed below have developed IVDs that have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. To date, 173 COVID-19 IVDs have received EUAs.

To learn more about these tests and their availability, please visit the links below to access each company’s COVID-19 test information portal.

Antigen Tests (11)

Tests to confirm an active infection by detecting viral proteins ("antigens") shed in a patient sample.

Company Test Point of Care Pooling Screening
Abbott BinaxNOW COVID-19 Ag Card ×    
Abbott BinaxNOW COVID-19 AG Card Home Test x    
Access Bio CareStart COVID-19 Antigen test ×    
Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 ×    
Cellitron USA Sampinute COVID-19 Antigen MIA      
Ellume Ellume COVID-19 Home Test x    
Luminostics LumiraDx SARS-CoV-2 Ag Test      
LumiraDx UK LumiraDx SARS-CoV-2 Ag Test x    
Quidel Sofia 2 SARS Antigen FIA x    
Quidel Sofia 2 Flu + SARS Antigen FIA x    
Quidel QuickVue SARS Antigen Test x    

Molecular Diagnostic Tests (107)

Tests to confirm an active infection by detecting the virus' genetic material (RNA) in a patient sample.

Company Test Point of Care Pooling Screening
1drop 1copy COVID-19 qPCR Multi Kit      
3B Blackbio Biotech TRUPCR SARS-CoV-2 Kit      
Abbott Abbott RealTime Sars-CoV-2 assay      
Abbott ID NOW COVID-19 x    
Abbott Alinity m SARS-CoV-2 assay      
Access Bio CareStart COVID-19 MDx RT-PCR      
Agena Bioscience MassARRAY SARS-CoV-2 Panel      
altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S.      
Applied BioCode BioCode SARS-CoV-2 Assay      
Applied DNA Sciences Linea COVID-19 Assay Kit      
Atlia BioSystems iAMP COVID-19 Detection Kit      
Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System      
Becton, Dickinson & Company (BD) BD SARS-CoV-2 Reagents for BD MAX System      
Beijing Wantai Biological Pharmacy Enterprise Co Wantai SARS-CoV-2 RT-PCR Kit      
BGI Genomics Co. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV      
BillionToOne qSanger-COVID-19 Assay      
BioCore Co. BioCore 2019-nCoV Real Time PCR Kit      
Bioeksen R&D Technologies Bio-Speedy Direct RT-qPCR SARS-CoV-2      
BioFire Defense Bio Fire® COVID-19 Test      
BioFire Diagnostics BioFire Respiratory Panel 2.1 (RP2.1)      
BioFire Diagnostics BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) x    
Biomeme Biomeme SARS-CoV-2 Real-Time RT-PCR Test      
bioMérieux SARS-COV-2 R-GENE      
Bio-Rad Laboratories Bio-Rad SARS-CoV-2 ddPCR Test;      
Bio-Rad Laboratories Bio-Rad SARS-CoV-2 ddPCR Kit      
BioSewoom Real-Q 2019-nCoV Detection Kit      
Bio TNS COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit      
Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay      
Cepheid Xpert® Xpress Sars-CoV-2; x    
Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV x    
Cepheid Xpert Omni SARS-CoV-2      
ChromaCode HDPCR SARS-CoV-2 Assay      
Clear Labs Clear Dx SARS-CoV-2 Test      
Co-Diagnostics Logix Smart Coronavirus Disease 2019 (COVID-19) Kit      
Cue Health Cue COVID-19 Test x    
Detectachem MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit      
DiaCarta QuantiVirus SARS-CoV-2 Test Kit;      
DiaCarta SARS-CoV-2 Multiplex Test Kit      
DiaSorin Molecular Simplexa™ COVID-19 Direct Kit      
dba SpectronRx Hymon SARS-CoV-2 Test Kit      
Enzo Life Sciences AMPIPROBE SARS-CoV-2 Test System      
Euroimmun US EURORealTime SARS-Cov-2      
Fast Track Diagnostics (Siemens Healthineers) FTD SARS-CoV-2      
Fluidigm Advanta Dx SARS-CoV-2 RT-PCR Assay      
Fosun Pharma USA Fosun COVID-19 RT-PCR Detection Kit      
Gencurix GenePro SARS-CoV-2      
GeneMatrix NeoPlex COVID-19 Detection Kit      
Genetron Health (Beijing) Co. Genetron SARS-CoV-2 RNA Test      
GenMark Diagnostics ePlex® SARS-CoV-2 Test;      
GenMark Diagnostics ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)      
GenoSensor GS COVID-19 RT-PCR KIT      
GK Pharmaceuticals Contract Manufacturing Operations GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT      
Gnomegen Gnomegen COVID-19 RT-Digital PCR Detection Kit      
Gnomegen Gnomegen COVID-19-RT-qPCR Detection Kit      
Hologic Panther Fusion® SARS-CoV-2 Test   x x
Hologic Aptima SARS-CoV-2 assay   x x
Hologic Aptima SARS-CoV-2/Flu assay      
Illumina Illumina COVIDSeq Test      
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit      
Jiangsu Bioperfectus Technologies Co. COVID-19 Coronavirus Real Time PCR Kit;      
Jiangsu Bioperfectus Technologies Co. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)      
KimForest Enterprise Co KimForest SARS-CoV-2 Detection Kit v1      
KogeneBiotech PowerChek 2019-nCoV Real-time PCR Kit      
LabGenomics Co. LabGun COVID-19 RT-PCR Kit      
Lucira Health Lucira COVID-19 All-In-One Test Kit   x  
Luminex Molecular Diagnostics NxTAG CoV Extended Panel Assay      
Luminex Molecular Diagnostics ARIES SARS-CoV-2 Assay      
LumiraDx LumiraDx SARS-CoV-2 RNA STAR      
Maccura Biotechnology (USA) SARS-Cov-2 Fluorescent PCR Kit      
Mammoth Biosciences SARS-CoV-2 DETECTR Reagent Kit      
MatMaCorp MatMaCorp COVID-19 2SF Test      
Mesa Biotech Accula™ SARS-Cov-2 Test x    
NeuMoDx Molecular NeuMoDx SARS-CoV-2 Assay      
OPTI Medical Systems OPTI SARS-CoV-2 RT PCR Test      
OPTOLANE Technologies Kaira 2019-nCoV Detection Kit      
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit      
PerkinElmer Coronavirus Nucleic Acid Detection Kit      
PlexBio Co. IntelliPlex SARS-CoV-2 Detection Kit      
PreciGenome FastPlex Triplex SARS-CoV-2 Detection Kit (RT-Digital PCR)      
PrimerDesign COVID-19 genesig Real-Time PCR assay      
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel      
Quadrant Biosciences Clarifi COVID-19 Test Kit      
Quidel Lyra SARS-CoV-2 Assay      
Quidel Lyra Direct SARS-CoV-2 Assay      
Rhenonix Rheonix COVID-19 MDx Assay      
Roche Diagnostics Cobas SARS-CoV-2   x  
Roche Diagnostics Cobas SARS-CoV-2 & Influenza A/B      
Roche Diagnostics Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System x    
RTA Laboratories Diagnovital SARS-CoV-2 Real-Time PCR Kit      
Sansure BioTech Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)      
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit      
Seasun Biomaterials U-TOP COVID-19 Detection Kit      
Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit      
Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit PLUS      
Seegene Allplex 2019-nCoV Assay      
SD Biosensor STANDARD M nCoV Real-Time Detection Kit      
Sherlock BioSciences Sherlock CRISPR SARS-Cov-2 Kit      
SolGent Co. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit      
Thermo Fisher Scientific TaqPath COVID-19 Combo Kit      
Trax Management Services PhoenixDx 2019-CoV      
Trax Management Services PhoenixDx SARS-CoV-2 Multiplex      
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test      
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test v2.0      
Visby Medical Visby Medical COVID-19      
Xiamen Zeesan Biotech Co. SARS-CoV-2 Test Kit (Real-time PCR)      
ZhuHai Sinochips Bioscience Co. COVID-19 Nucleic Acid RT-PCR Test Kit      
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit      

 

Serology Tests (53)

Blood-based tests that can be used to identify whether individuals have been exposed to COVID-19 by examining the presence of antibodies to the virus. Serology testing will be a key component of a national strategy to safely get Americans back to work.

Company Test Point of Care Pooling Screening
Abbott SARS-CoV-2 IgG assay      
Accelerate Diagnostics BioCheck SARS-CoC-2 IgG and IgM Combo Test      
Accelerate Diagnostics BioCheck SARS-CoV-2 IgG Antibody Test Kit      
Access Bio CareStart COVID-19 IgM/IgG      
ACON Laboratories ACON SARS-CoV-2 IgG/IgM Rapid Test      
Assure Tech Assure COVID-19 IgG/IgM Rapid Test Device   x  
Autobio Diagnostics Co. Anti-SARS-CoV-2 Rapid Test      
Beckman Coulter Access SARS-CoV-2 IgG      
Beckman Coulter Access SARS-CoV-2 IgM      
Beijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab Rapid Test      
Beijing Wantai Biological Pharmacy Enterprise WANTAI SARS-CoV-2 Ab ELISA      
Biocan Diagnostics Tell Me Fast Coronavirus (COVID-19) IgG/IgM Antibody Test      
bioMérieux VIDAS SARS-CoV-2 IgG      
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab Assay      
Biohit Healthcare (Hefei) Co. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit      
Cellex qSARS-CoV-2 IgG/IgM Rapid Test      
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG      
DiaSorin DiaSorin LIAISON SARS-CoV-2 IgM Assay      
Diazyme Laboratories Diazym DZ-Lite SARS-CoV-2 IgG CLIA Kit;      
Diazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit      
EUROIMMUN US Anti-SARS-CoV-2 ELISA (IgG)      
Genalyte Maverick SARS-CoV-2 Multi Antigen Serology Panel v2      
GenScript USA cPass SARS-CoV-2 Neutralization Antibody Detection Kit      
Hangzhou Biotest Biotech Co. RightSign COVID-19 IgG/IgM Rapid Test Cassette      
Hangzhou Laihe Biotech Co. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Anitbody Combo Test Kit (Colloidal Gold)      
Healgen Scientific COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)      
InBios International SCoV-2 Detect IgG ELISA;      
Innovita (Tangshan) Biological Technology Co. Innovita 2019-nCoV Ab Test (Colloidal Gold)      
Jiangsu Well Biotech Co Orawell IgM/IgG Rapid Test      
Kantaro Biosciences COVID-SeroKlir,Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit      
Luminex xMap SARS-CoV-2 Multi-Antigen IgG Assay      
Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit      
NanoEntek America FREND COVID-19 total Ab      
Nirmidas Biotech Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit      
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack      
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack      
Quansys Biosciences Q-Plex SARS-CoV-2 Human IgG (4 Plex)      
Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine      
Roche Elecsys Anti-SARS-CoV-2      
Roche Elecsys Anti-SARS-CoV-2 S      
Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette      
Shenzen New Industries Biomedical Engineering Co MAGLUMI 2019-nCoV IgM/IgG      
Siemens ADVIA Centaur SARS-CoV-2 Total (COV2T)      
Siemens Atellica IM SARS-CoV-2 Total (COV2T)      
Siemens Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)      
Siemens Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)      
Siemens Atellica IM SARS-CoV-2 IgG (COV2G); ADVIA Centaur SARS-CoV-2 IgG (COV2G)      
Sugentech SGTi-flex COVID-19 IgG      
TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit      
TBG Biotechnology Corp. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit      
Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test      
Xiamen Biotime Biotechnology Co. BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test      
ZEUS Scientific ZEUS ELISA SARS-CoV-2 IgG Test System      
 

EUA Tests Specific to Clinical Care of COVID-19 Patients (2)

These tests can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.

 

Company Test Point of Care Pooling Screening
Roche Elecsys IL-6      
Beckman Coulter Access IL-6