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Coronavirus Test Tracker: Commercially Available COVID-19 Diagnostic Tests

As labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets

The tracker includes only those tests that are available for diagnostic and clinical use. Links to primary regulatory decisions are provided where available. We rely on information provided by manufacturers and regulatory authorities. If you're a test manufacturer or provider and believe your test should be on this tracker, please email us at [email protected].

Last updated: Sept. 30, 2020

 

EUA: Emergency Use Authorization

EUA submission pending: Test manufacturers have indicated that they have submitted an EUA application. FDA requires labs and commercial manufacturers to submit an EUA request within 10 days (serological test) or 15 days (molecular test) of completing test validation.

Under CDC's EUA: these manufacturers are covered under the EUA granted to the US Centers for Disease Control and Prevention

*See US FDA Revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency

Company/Organization
Name
Test NameUS Regulatory Status*EU Regulatory StatusAsia Regulatory StatusTechnology
1drop

1copy COVID-19 qPCR Multi Kit

EUA 5/11/2020   PCR
3B Blackbio Biotech India (Kilpest India subsidiary)

TRUPCR SARS-CoV-2 Kit

EUA 6/18/2020  PCR
3D Medicines

SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit


 CE mark 3/2020 PCR
Abacus Diagnostica

GenomEra SARS-CoV-2 Assay

 CE mark 7/2020 PCR
Abbott

BinaxNOW COVID-19 Ag Card

EUA 8/26/2020

  Antigen
AbbottSARS-CoV-2 IgG test

EUA 4/26/2020, amended 5/9/2020

  Serological
AbbottID Now COVID-19EUA 3/27/2020  isothermal amplification
AbbottAbbott RealTime SARS-CoV-2 EUA testEUA 3/18/2020  PCR

Access Bio

CareStart COVID-19 IgM/IgG

EUA 7/24/2020  Serological

Access Bio

CareStart COVID-19 MDx RT-PCR

EUA 7/7/2020  PCR

Access Genetics

OraRisk COVID-19 RT-PCR

EUA 7/17/2020  PCR

Acupath Laboratories

Acupath COVID-19 Real-Time (RT-PCR) Assay

EUA 6/29/2020  PCR

ADS Biotec

SARS-CoV-2 IgM/IgG Antibody Test Kit

EUA 6/18/2020CE mark 3/2020 Serological

Advanced Biological Laboratories

UltraGene Combo2Screen SARS-CoV-2 assay

 CE mark 5/2020 PCR

AEP Alliance (Antaimmu Biomed, EirGenix, Panion & BF Biotech)

Vstrip COVID-19 Antigen Rapid Test

  

Taiwan Emergency Use Authorization 8/2020

Indian Council of Medical Research validation 9/2020

Antigen

Agena Bioscience

SARS-CoV-2 Panel

EUA submission pending  PCR

AIT Laboratories

SARS-CoV-2 Assay

EUA 4/24/2020  PCR
Akston Biosciences

AntiCoV-ID IgG ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgG ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgM ELISA

EUA submission pending  Serological
Alpha Genomix Laboratories

Alpha Genomix TaqPath SARS-CoV-2 Combo Assay

EUA 8/10/2020  PCR
Altru Diagnostics

Altru Dx SARS-CoV-2 RT-PCR assay

EUA 4/30/2020   PCR
Altona Diagnostics

RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions)

EUA 4/22/2020CE mark 4/2020 PCR
Anatolia GeneworksBosphore Novel Coronavirus (2019-nCoV) Detection Kit CE mark 2/2020 PCR

Applied BioCode

BioCode SARS-CoV-2 Assay

EUA 6/15/2020  PCR

Applied DNA Sciences

Linea COVID-19 RT-PCR test

EUA 5/13/2020  PCR
ArcDia InternationalMariPOC COVID-19 test CE mark 5/2020 Antigen

Aspirus Reference Laboratory

Aspirus SARS-CoV rRT-PCR Assay

EUA 6/1/2020  PCR
Assurance Scientific Laboratories

Assurance SARS-CoV-2 Panel

EUA 5/15/2020  PCR

Assure Tech (Hangzhou Co.)

Assure COVID-19 IgG/IgM Rapid Test Device

EUA 7/6/2020  Serological

A*STAR,Tan Tock Seng Hospital of Singapore

A*STAR Fortitude 2.0

  Singapore Health Sciences Authority provisional authorizationPCR

Atila BioSystems

iAMP COVID-19 Detection Kit

EUA 4/10/2020  Isothermal amplification
AusDiagnostics

AusDiagnostics SARS-CoV-2, influenza, RSV panel

 CE mark 3/2020 PCR
Autobio DiagnosticsAnti-SARS-CoV-2 Rapid Test

EUA 4/24/2020

EUA revoked 8/6/2020

CE mark Serological
Avellino LabAvellino SARS-CoV-2/COVID-19 (AvellinoCoV2)EUA 3/25/2020  PCR

Avera Institute for Human Genetics

Avera Institute for Human Genetics SARS-CoV-2 Assay

EUA 5/22/2020   PCR

Babson Diagnostics

Babson Diagnostics aC19G1

EUA 6/23/2020  Serological

BAG Diagnostics

Viro-Q SARS-CoV-2 kit

 CE mark 4/2020 PCR

Bako Diagnostics

BakoDx SARS-CoV-2 RNA test

EUA submission pending  PCR

Baptist Hospital Miami Pathology/Laboratory Medicine Lab

COVID-19 RT-PCR Test

EUA 4/13/2020  PCR

BayCare Laboratories

BayCare SARS-CoV-2 RT PCR Assay 

EUA 8/31/2020  PCR

Beckman Coulter

Access SARS-CoV-2 IgG

EUA 6/26/2020CE mark 6/2020 Serological

Becton Dickinson

BD Veritor System for Rapid Detection of SARS-CoV-2

EUA 7/2/2020  Antigen

Becton Dickinson

BD SARS-CoV-2 Reagents for BD MAX System

EUA 4/8/2020  PCR

Becton Dickinson, BioGx

BioGX SARS-CoV-2 Reagents for the BD MAX System

EUA 4/2/2020  PCR

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 RT-PCR Kit

EUA 9/9/2020  PCR

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab ELISAEUA 8/5/2020   Serological

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab Rapid Test

EUA 7/10/2020  Serological
Beroni GroupSARS-CoV-2 IgG/IgM Antibody Detection Kit CE mark 4/2020 Serological
BGI (BGI PathoGenesis Pharmaceutical Technology)SARS-CoV-2 and Influenza A/B RT-PCR Kits CE mark 9/2020 PCR
BGIReal-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoVEUA 3/26/2020CE mark 3/2/2020China NMPA 1/2020PCR

BillionToOne

qSanger-COVID-19 Assay

EUA 9/4/2020  Sequencing

Biocan Diagnostics

Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

EUA 8/25/2020  Serological

Biocerna

SARS-CoV-2 TestEUA 4/28/2020  PCR

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM Antibody Test KitEUA 9/9/2020  Serological

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgG Antibody Test Kit

EUA 9/9/2020  Serological

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM and IgG Combo TestEUA 8/17/2020  Serological

Biocollections Worldwide

Biocollections Worldwide SARS-Co-V-2 AssayEUA 5/7/2020  PCR

BioCore

BioCore 20019-nCoV Real Time PCR Kit

EUA 5/21/2020  PCR

Biodesix

 

SARS-CoV-2 Droplet Digital PCR (ddPCR) test

EUA submission pending  PCR

Bioeksen R&D Technologies

Bio-Speedy Direct RT-qPCR SARS-CoV-2

EUA 9/2/2020  PCR

Biohit Healthcare (Hefei)

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

EUA 6/18/2020  Serological

BioMedomics

COVID-19 IgM-IgG Rapid Test

 CE mark 3/2020 Serological
Biomeme

Biomeme SARS-CoV-2 Real-Time RT-PCR Test

EUA 8/11/2020   PCR
Biomerica

COVID-19 IgG/IgM Rapid Test

 CE mark 5/2020 Serological
BioMérieux

Vidas anti-SARS-CoV-2 IgM test

EUA 8/6/2020 CE mark 5/2020 Serological
BioMérieuxVidas anti-SARS-CoV-2 IgG testEUA 8/6/2020 CE mark 5/2020 Serological
BioMérieux 

SARS-COV-2 R-GENE test

EUA 5/6/2020CE mark 4/10/2020 PCR

BioMérieux/BioFire Defense

BioFire COVID-19 test

EUA 3/23/2020  PCR
BioMérieux/BioFire Diagnostics

BioFire Respiratory Panel 2.1 (RP2.1) (EUA)

BioFire Respiratory Panel 2.1 plus (CE mark)

EUA 5/1/2020 CE mark 7/2020 PCR
Bioneer

AccuPower COVID-19 Real-Time RT-PCR Kit, AccuPower SARS-CoV-2 Real-Time RT-PCR Kit

 CE mark PCR
Biopanda Reagents

COVID-19 Rapid Antibody Test

 CE mark 3/2020 Serological
Bio-Rad Laboratories

Bio-Rad SARS-CoV-2 ddPCR Test

EUA 5/1/2020  PCR
Bio-Rad Laboratories

Platelia SARS-CoV-2 Total Ab assay

EUA 4/29/2020 CE mark 4/2020 Serological
BioReference Laboratories

Novel Coronavirus COVID-19

EUA submission pending  PCR
BioSewoonReal-Q 2019-nCoV Detection KitEUA 7/9/2020  PCR
Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL)Childrens-Altona-SARS-CoV-2 assayEUA 4/14/2020  PCR

Boston Heart Diagnostics

Boston Heart COVID-19 RT-PCR Test

EUA 7/16/2020  PCR

Boston Medical Center

BMC-CReM COVID-19 Test

EUA 7/10/2020   PCR

Broad Institute Clinical Research Sequencing Platform (CRSP)

CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay

EUA 7/8/2020  PCR

Bruker

FluoroType SARS-CoV-2 plus

 CE mark 5/5/2020 PCR

Capstone Healthcare

Genus SARS-CoV-2 Assay

EUA 8/3/2020  PCR

Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine

SARS-CoV-2-Assay

EUA 5/13/2020  PCR
Cellex

qSARS-CoV-2 IgG/IgM Rapid Test

EUA 4/1/2020  Serological
Centers for Disease Control and PreventionCDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)EUA 2/4/2020, amended 3/15/2020  PCR
Centers for Disease Control and Prevention

Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay

EUA 7/2/2020  PCR
Centogene

SARS-CoV-2 RT-PCR test

EUA 7/1/2020  PCR
Cepheid

Xpert Xpress SARS-CoV-2/Flu/RSV test

EUA 9/24/2020  PCR
Cepheid

Xpert Xpress SARS-CoV-2 test

EUA 3/20/2020  PCR
CerTest BioTecViaSure SARS-CoV-2 Real Time PCR Detection Kit CE mark 3/2020 on the Becton Dickinson BD Max system PCR
Chembio Diagnostics
DDP COVID-19 IgM/IgG System

EUA 4/14/2020

EUA revoked 6/16/2020

  Serological

Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

SARS-CoV-2 RT-PCR testEUA 4/2/2020  PCR

ChromaCode

HDPCR SARS-CoV-2 real-time PCR assayEUA 6/9/2020  PCR

CirrusDx Laboratories

CirrusDx SARS-CoV-2 Assay

EUA 4/15/2020   PCR
Clear Labs

Clear Dx SARS-CoV-2

EUA 9/23/2020  Sequencing
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute

Cleveland Clinic SARS-CoV- Assay

EUA 8/3/2020  PCR
Clinical Reference Laboratory

CRL Rapid Response

EUA 7/30/2020  Molecular
Co-Diagnostics

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020CE mark 2/2020 PCR

Color

Color COVID-19 Self-Swab Collection Kit

EUA 8/31/2020  Collection kit

Color

Color SARS-CoV-2 LAMP Diagnostic Assay

EUA 5/18/2020, amended 7/24/2020  Isothermal amplification

Columbia University Laboratory of Personalized Genomic Medicine

Triplex CII-CoV-1 rRT-PCR Test

EUA 5/12/2020  PCR
Compass Laboratory ServicesCompass Laboratory Services SARS-CoV2 AssayEUA 7/13/2020  PCR, Home Collection
Cormeum Laboratory ServicesCormeum SARS-CoV-2 AssayEUA 6/12/2020  PCR
CoWin Biotech

Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

EUA 7/24/2020  PCR
Credo Diagnostics BiomedicalVitaPCR SARS-CoV2 Assay CE mark 3/2020Singapore Health Sciences Authority provisional authorization
PCR

CSI Laboratories

CSI SARS-CoV-2 RT PCR Test

 
EUA 6/1/2020  PCR
CTK Biotech

OnSite COVID-19 IgG/IgM Rapid Test

EUA submission pendingCE mark Q1/2020 Serological
CTK Biotech

Aridia COVID-19 PCR Test

 CE mark Q2/2020  
Cue Health

Cue COVID-19 Test

EUA 6/10/2020  PCR

Cuur Diagnostics

Cuur Diagnostics SARS-CoV-2 Molecular Assay

 
EUA 8/26/2020   PCR 
Darwin Biosciences

CoVLab

EUA submission pending  PCR
Dba SpectronRx

Hymon SARS-CoV-2 Test Kit

EUA 5/22/2020  PCR

Detectachem

MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit

EUA 9/1/2020  isothermal amplification
DiaCarta

QuantiVirus SARS-CoV-2 Multiplex Test Kit

EUA 7/21/2020  PCR
DiaCarta

QuantiVirus SARS-CoV-2 test kit

EUA 4/8/2020CE mark 3/2020 PCR
Diagnostics Development HubFortitude Kit 2.0E  Singapore Health Sciences Authority provisional authorization 2/2020PCR
Diagnostic Solutions LaboratoryDSL COVID-19 AssayEUA 6/25/2020  PCR
DiaSorin

Liaison SARS-CoV-2 S1/S2 IgG

EUA 4/24/2020  CE mark 4/2020 Serological
DiaSorin Molecular

Simplexa COVID-19 Direct

EUA 3/19/2020 CE mark 4/2020 PCR
Diatherix Eurofins LaboratorySARS-CoV-2 PCR TestEUA 4/22/2020  PCR
Diazyme Laboratories

Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit

EUA 7/8/2020  Serological
Diazyme Laboratories 

Diazyme DZ-Lite SARS-CoV-2 IgM

EUA 8/17/2020  Serological

DNA-Technology Research & Production

SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit

 CE mark 4/2020 PCR

DxTerity Diagnostics

 

DxTerity SARS-CoV-2 RT PCR CE Test

EUA 8/28/2020   PCR 

DxTerity Diagnostics

DxTerity SARS-CoV-2 RT-PCR Test

EUA 8/21/2020  PCR
Eli Lilly

Lilly SARS-CoV-2 Assay

EUA 7/27/2020  PCR
Emory Medical Laboratories

SARS-CoV-2 RBD IgG test

EUA 6/15/2020  Serological
Empirical Bioscience

QuantiTase, QuantiTase Plus One Step RT-qPCR Kits

EUA submission pending  PCR
Ender Diagnostics

Ender Lab

 CE mark 6/2020 PCR
Ender Diagnostics

Ender Mass

 CE mark 8/2020 Isothermal amplification
Enzo Biochem

Genflex Molecular Diagnostic Modular System (for SARS-CoV-2 Detection)

EUA submission pending  PCR
Enzo Biochem

SARS-CoV-2 IgG ELISA assay kit

EUA submission pending  Serological
Enzo Biochem/Enzo Life Sciences

Ampiprobe SARS-CoV-2 Test System

EUA 7/7/2020  PCR
Erba Mannheim

ErbaLisa COVID-19 IgM ELISA

 CE mark 4/2020 Serological
Erba Mannheim

ErbaLisa COVID-19 IgG ELISA

 CE mark 4/2020 Serological
Ethos Laboratories

Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay

EUA 8/3/2020  Mass spectrometry
Eurofins Ingenasa

Ingezim COVID 19 DR

 CE mark 6/2020 Serological
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgG)

EUA 5/4/2020  Serological
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2

EUA 6/8/2020CE mark 3/2020 PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgA)

 CE mark 3/2020 Serological

Everlywell

Everlywell COVID-19 Test Home Collection Kit

EUA 5/15/2020  Home collection kit

Exact Sciences

Exact Sciences SARS-CoV-2 (N gene detection) Test

EUA 5/22/2020  PCR

Exact Sciences

SARS-CoV-2 Test

EUA 4/14/2020  PCR

Express Gene (dba Molecular Diagnostics Laboratory)

Express Gene 2019-nCoV RT-PCR Diagnostic Panel

 
EUA 5/22/2020   PCR

Fluidigm

Advanta Dx SARS-CoV-2 RT-PCR Assay

EUA 8/25/2020  PCR

Fosun Pharma USA

Fosun COVID-19 RT-PCR Detection Kit

EUA 4/17/2020  PCR
Fulgent Genetics/Fulgent TherapeuticsFulgent COVID-19 by RT-PCR TestEUA 5/15/2020  PCR
Fulgent Genetics/MedScan LaboratoryCOVID-19EUA submission pending  Sequencing
Genalyte

Maverick SARS-CoV-2 Multi-Antigen Serology Panel

EUA submission pending  Serological
Gencurix

GenePro SARS-CoV-2 Test

EUA 6/23/2020  PCR
Gene By Gene

Gene By Gene SARS-CoV-2 Detection Test

EUA 7/7/2020  PCR
Genedrive

Genedrive 96 SARS-CoV-2 Kit

EUA submissiong pendingCE mark 5/2020 PCR
GeneMatrix

NeoPlex COVID-19 Detection Kit

EUA 5/14/2020  PCR
General Biologicals

GB SARS-CoV-2 Ab ELISA kit

 CE mark 8/2020 Serological
General Biologicals

GB SARS-CoV-2 Real-Time RT-PCR

 CE mark 4/2020Taiwan FDA approval; India Central Drugs Standard Control Organisation approvalPCR
GeneStore France 

Detection Expert SARS-Cov-2 RT-PCR Test

 CE mark 4/2020 PCR
Genetic Signatures

EasyScreen SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
Genetrack Biolabs

Genetrack SARS-CoV-2 Molecular Assay

EUA 9/25/2020  PCR
Genetron

Genetron SARS-CoV-2 RNA Test

EUA 6/5/2020CE mark 4/2020 PCR
GenMark Diagnostics

ePlex SARS-CoV-2 Test

EUA 3/19/2020  PCR
Genomica/PharmMar Group2 kits: qCOVID-19, CLART COVID-19 CE mark 3/2020 PCR

GenScript Biotech

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

EUA submission pendingCE mark 5/2020 Serological

GenoSensor

GS COVID-19 RT-PCR Kit

EUA 4/16/2020   PCR

George Washington University Public Healt Laboratory

GWU COVID-19 RT-PCR Test

EUA 8/7/2020  PCR

GK Pharmaceuticals Contract Manufacturing Operations

GK Accu-Right SARS-CoV-2 RT-PCR Kit

EUA 9/18/2020  PCR

Gnome Diagnostics

GnomeDX RT-PCR COVID-19 Test

EUA submission pending  PCR

Gnomegen

Gnomegen COVID-19-RT-qPCR Detection Kit

EUA 5/8/2020  PCR

Gnomegen

Gnomegen COVID-19 RT-Digital PCR Detection Kit

EUA 4/6/2020  PCR
Gold Standard Diagnostics/Eurofins Technologies

GSD NovaPrime SARS-CoV-2 (COVID-19) Real-Time PCR test

 CE mark 5/2020 PCR
Gold Standard Diagnostics/Eurofins Technologies
NovaLisa SARS-CoV-2 (US: GSD SARS-CoV-2) IgG, IgM, IgA assays
CE mark 4/2020 Serological

Gravity Diagnostics

Gravity Diagnostics COVID-19 Assay   EUA 6/1/2020  PCR

Guardant Health

Guardant-19

EUA 8/21/2020  Sequencing

Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory

CDI Enhanced COVID-19 Test

 
EUA 4/15/2020  PCR
Hai Kang Life

COVID-19 RT-PCR, ERT-PCR tests

 CE mark 7/2020 PCR
Hangzhou AllTest Biotech

2019-nCoV IgG/IgM Rapid Test Cassette

EUA submission pendingCE mark 2/2020 Serological
Hangzhou Biotest Biotech

RightSign COVID-19 IgG/IgM Rapid Test Cassette

EUA 6/4/2020  Serological
Healgen Scientific

2019-nCoV Direct qPCR Kit

 CE mark 4/2020 PCR
Healgen ScientificCOVID-19 IgG/IgM Rapid Test Cassette CE mark 4/2020 Serological
Healgen Scientific/Zhejiang Orient Gene Biotech

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

EUA 5/29/2020   Serological
HealthQuest EsotericsHealthQuest Esoterics TaqPath SARS-CoV-2 AssayEUA 6/23/2020  PCR
HelixHelix COVID-19 NGS TestEUA 8/6/2020  Sequencing
HelixHelix COVID-19 TestEUA 7/23/2020  PCR
HologicPanther Fusion SARS-CoV-2 assayEUA 3/16/2020  PCR
Hologic

Aptima SARS-CoV-2 assay

EUA 5/14/2020  PCR
Illumina

COVIDSeq Test 

EUA 6/9/2020  Sequencing
Immundiagnostik

IDK anti-SARS-CoV-2 IgG ELISA 

  CE Mark 5/2020 Serological
Immundiagnostik

MutaPLEX Coronavirus 

  CE Mark 4/2020 PCR
InBios International

SCoV-2 Detect IgG ELISA kit 

EUA 6/10/2020  Serological
InBios International

SCoV-2 Detect IgM ELISA kit

EUA 7/1/2020  Serological
InBios International

Smart Detect SARS-CoV-2 rRT-PCR Kit

EUA 4/7/2020  PCR
Inform Diagnostics

Inform Diagnostics SARS-CoV-2 RT-PCR Assay

EUA 6/26/2020  PCR

Innocreate Bioscience

Innocreate SARS-CoV-2 QD kit  Taiwan Food and Drug Administration approvalPCR
Integrated DNA Technologies/DanaherIDT 2019-novel coronavirus kitunder CDC's EUA
  PCR

Integrity Laboratories

SARS-CoV-2 Assay

EUA 4/13/2020  PCR
Ipsum Diagnostics

COV-19 IDx assay

EUA 4/1/2020  PCR

Jiangsu Bioperfectus Technologies

COVID-19 Coronavirus Real Time PCR Kit

EUA 6/18/2020  PCR

Jiangsu Well Biotech

Orawell IgM/IgG Rapid Test

EUA 9/23/2020  Serological

JN Medsys

ProTect Covid-19 kit

 under CDC's EUACE mark 4/2020Singapore Health Sciences Authority provisional authorization; Philippines Food and Drug AdministrationPCR
Kaiser Permanente Mid-Atlantic StatesKPMAS COVID-19 TestEUA 6/13/2020  PCR
Kephera Diagnostics 

KDx SARS-CoV-2 IgG/IgM ELISA

EUA submission pending  Serological
KimForest Enterprise

KimForest SARS-CoV-2 Detection Kit v1

EUA 9/21/2020  PCR
Kogene Biotech

PowerChek 2019-nCoV Real-time PCR Kit

EUA 7/13/2020CE markEUAL, Korea Centers for Disease Control and the Korea Food and Drug AdministrationPCR

KorvaLabs

Curative-Korva SARS-Cov-2 Assay

EUA 4/16/2020  PCR

Kroger Health

Kroger Health COVID-19 Test Home Collection Kit

EUA 6/30/2020  Home collection kit
LabGenomics

LabGun COVID-19 RT-PCR Kit

EUA 4/29/2020  PCR
Laboratorio Clinico ToledoLaboratorio Clinico Toledo SARS-CoV-2 AssayEUA 7/6/2020  PCR
Laboratory Corporation of AmericaCOVID-19 RT-PCR TestEUA 3/16/2020, reissued 4/20/2020, amended 7/24/2020  PCR
LetsGetChecked (PrivaPath Diagnostics)

LetsGetChecked Coronavirus (COVID-19) Test

EUA 5/28/2020  PCR
LGC, Biosearch Technologies

2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2

under CDC's EUA  PCR
LifeHope Labs

LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel

EUA 6/29/2020  PCR
Luminex

xMAP SARS-CoV-2 Multi-Antigen IgG Assay

EUA 7/16/2020  Serological
Luminex

ARIES SARS-CoV-2 Assay

EUA 4/3/2020, amended 5/11/2020  PCR
Luminex

NxTAGCoV Extended Panel Assay

EUA 3/27/2020  PCR

LumiraDx

LumiraDx SARS-CoV-2 Ag Test

EUA 8/18/2020  Antigen

LumiraDx

LumiraDx SARS-CoV-2 RNA STAR

EUA 8/11/2020   PCR

Maccura Biotechnology

SARS-CoV-2 Fluorescent PCR Kit

EUA 4/15/2020  PCR

Mammoth Biosciences

SARS-CoV-2 DETECTR Reagent Kit 

EUA 8/31/2020  CRISPR 

Massachusetts General Hospital

MGH COVID-19 qPCR assay

EUA 4/3/2020   PCR
Mayo Clinic Laboratories

SARS-CoV-2 Molecular Detection Assay

EUA 4/20/2020  PCR
Mediagnost

Anti-SARS-CoV-2 ELISA

 CE mark 5/2020 Serological
MedMiraREVEALCOVID-19 total antibody testEUA submission pendingCE mark 5/2020 Serological
Megna HealthRapid COVID-19 IgM/IgG Combo Test KitEUA 7/17/2020  Serological
Mesa BiotechAccula SARS-CoV-2 testEUA 3/23/2020  PCR

MicroGenDx (Southwest Regional PCR Laboratory)

COVID-19 Key

EUA 3/23/2020  PCR

MiraDx

MiraDx SARS-CoV-2 RT-PCR assay 

EUA 8/31/2020  PCR

Mobidiag

Novodiag COVID-19

 CE mark 6/2020 PCR

Mobidiag

Amplidiag COVID-19

 CE mark 6/2020 PCR

Mount Sinai Labs

COVID-19 ELISA IgG Antibody Test

EUA 4/15/2020   Serological

MP Biomedicals Asia Pacific

Assure SARS-CoV-2 IgG/IgM rapid test

  Singapore Health Sciences Authority provisional authorizationSerological

Nal von minden

Nadal COVID-19 IgG/IgM test

 CE mark 3/2020 Serological

Nationwide Children's Hospital

SARS-CoV-2 Assay

EUA 4/27/2020  PCR

Nebraska Medicine Clinical Laboratory

NEcov19 RT-PCR Assay

EUA 6/4/2020   PCR

Neomedica

Naissa SARS-CoV-2 IgM

 CE Mark 7/2020 Serological

Neomedica

Naissa SARS-CoV-2 IgG

 CE Mark 7/2020 Serological

Neomedica

Naissa SARS-CoV-2 IgA

 CE Mark 7/2020 Serological

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020CE mark 5/2020 PCR

NGeneBio

NGenePlex nCoV qRT-PCR kit

EUA submission pendingCE mark 7/2020 PCR

Northwestern Medicine Diagnostic Molecular Laboratory

SARS-Cov-2 Assay

EUA 4/2/2020  PCR
Novacyt/PrimerdesignCOVID-19 Genesig Real-Time PCR assayEUA 3/20/2020CE mark 2/2020

EUA, India 3/26/2020

Thailand Ministry of Health, 4/2/2020

PCR
NowDiagnosticsAdexusDx COVID-19 Total Antibody Rapid Test CE mark 7/2020 Serological
NY State Department of Health (performed at Wadsworth Center and New York City Department of Health and Mental Hygiene, Public Health Laboratories)New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel EUA 3/10/2020  PCR

Ohio State University Wexner Medical Center

OSUWMC COVID-19 RT-PCR test

EUA 6/17/2020  PCR

Omnipathology Solutions Medical Corporation

Omni COVID-19 Assay by RT-PCR

EUA 6/17/2020  PCR

One Health Laboratories

SARS-CoV-2 Real-Time RT-PCR-Test

EUA 5/13/2020   PCR

OpGen

SARS-CoV-2 Kit with PULB CE mark 8/2020 PCR

Opti Medical Systems

Opti SARS-CoV-2 RT-PCR kit EUA 5/6/2020CE mark 6/2020 PCR

Optolane Technologies

Kaira 2019-nCoV Detection kit

EUA 9/1/2020CE mark 4/2020 PCR

Orig3n

Orig3n 2019 Novel Coronavirus (COVID-19) Test

EUA 4/10/2020  PCR

Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test

 CE mark 5/2020 Serological

Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators

EUA 4/14/2020, amended 5/9/2020

CE mark 5/2020 Serological
Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack/Calibrator

EUA 4/24/2020

  Serological
Osang HealthcareGeneFinder COVID-19 Plus RealAmp KitEUA 4/18/2020CE mark 2/2020 PCR
P23 Labs

P23 Labs TaqPath SARS-CoV-2 Assay

EUA 5/21/2020  PCR
PathoFinder

RealAccurate Quadruplex Corona-plus PCR Kit

 CE mark 4/2020 PCR
PathoFinder

RealAccurate Quadruplex SARS-CoV-2 PCR Kit

 CE mark 6/2020 PCR

Patients Choice Laboratories

PCL SARS-CoV-2 Real-Time RT-PCR Assay

EUA 8/28/2020   PCR 
PerkinElmer

SuperFlex Anti-SARS-CoV-2 IgG kit

 CE mark 7/2020 Serological
PerkinElmer

PerkinElmer GSP/DELFIA Anti-SARS-CoV-2 IgG kit

 CE mark 7/2020 Serological
PerkinElmer

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020CE mark 3/2020 PCR
Phosphorus Diagnostics

Phosphorus COVID-19 RT-qPCR Test

EUA 6/4/2020  PCR
PlexBio

IntelliPlex SARS-CoV-2 Detection Kit

EUA 6/25/2020CE mark 5/2020 PCR
Poplar Healthcare

Poplar SARS-CoV-2 TMA Pooling assay

EUA 8/3/2020  Isothermal amplification
PreciGenome

FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)

EUA 6/25/2020  PCR
Pro-Lab Diagnostics

Pro-AmpRT SARS-CoV-2 Test

EUA 8/13/2020  Isothermal amplification
ProterixBioSARS-CoV-2 (RBD) IgG Antibody testEUA submission pending  Serological
PsomagenPsoma COVID-19 RT TestEUA 6/30/2020  PCR
QDx Pathology ServicesQDX SARS-CoV-2 AssayEUA 8/25/2020  PCR
QiagenQiaStat-Dx Respiratory SARS-CoV-2 PanelEUA 3/30/2020CE mark 3/2020 PCR
Quadrant Biosciences

Clarifi COVID-19 Test Kit

EUA 9/22/2020  PCR
QuantuMDxSARS-CoV-2 RT-PCR Detection AssayEUA submission pendingCE mark 6/2020 PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics HA SARS-CoV-2EUA 7/15/2020  PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics RC SARS-CoV-2 AssayEUA 7/15/2020  PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics PF SARS-CoV-2 AssayEUA 7/15/2020  PCR
Quest DiagnosticsCoronavirus Disease 2019 (COVID-19) TestEUA 3/17/2020, reissued 7/18/2020  PCR
QuidelSofia 2 SARS Antigen FIAEUA 5/8/2020CE mark 7/2020 Antigen
QuidelLyra SARS-CoV-2 AssayEUA 3/17/2020, amended 3/23/2020CE mark 3/2020 PCR

Quidel

Lyra Direct SARS-CoV-2 Assay

EUA 5/18/2020CE mark 5/2020 PCR

Quotient Limited/Quotient Suisse

MosaiQ COVID-19 Antibody Microarray

EUA 9/25/2020CE mark 5/2020 Serological

R-Biopharm

Rida Gene SARS-CoV-2

 CE mark 5/2020 PCR

Rendu Biotechnology

2019-nCoV detection kit

  China NMPA 3/2020Isothermal amplification
RheonixRheonix COVID-19 MDx AssayEUA 4/29/2020  PCR
Roche

Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test (for Cobas Liat system)

EUA 9/14/2020  PCR
Roche

Cobas SARS-CoV-2 & Influenza A/B

EUA 9/3/2020   PCR
Roche

Elecsys Anti-SARS-CoV-2

EUA 5/2/2020  Serological
RocheCobas SARS-CoV-2 TestEUA 3/12/2020CE mark 2020 PCR

RTA Laboratories

Diagnovital SARS-CoV-2 Real-Time PCR Kit

EUA 6/12/2020  PCR

Rutgers University Clinical Genomics Laboratory

ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit

 
EUA 4/10/2020, amended 5/7/2020  PCR

Salofa

Sienna-Clarity Coviblock COVID-19 IgG/IgM Rapid Test Cassette

EUA 7/13/2020  Serological

Sandia National Laboratories

SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay

EUA 7/27/2020  PCR

Sansure BioTech

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

EUA 5/4/2020   PCR

ScienCell Research Laboratories

ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit

EUA 4/3/2020  PCR
SD Biosensor

Standard M nCoV Real-Time Detection Kit

EUA 4/23/2020  PCR
SD Biosensor

Standard Q COVID-19 IgM/IgG Duo Test

   Serological
Seasun Biomaterials

U-TOP COVID-19 Detection Kit

EUA 4/27/2020  PCR
Seasun Biomaterials

AQ-TOP COVID-19 Rapid Detection Kit

EUA 5/21/2020  Isothermal amplification
SeegeneAllplex 2019-nCoV AssayEUA 4/21/2020CE mark 2/2020EUA, Korea Ministry of Food and Drug SafetyPCR

Sentinel Diagnostics

STAT-NAT COVID-19 HK kit, B kit CE mark 3/2020 PCR

SeqOnce Biosciences

AzureSeq SARS-CoV-2 RT-qPCR KitEUA submission pending  PCR

Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical

 

novel coronavirus nucleic acid detection kit

 CE mark 3/2020China NMPA 3/2020PCR

Shenzhen New Industries Biomedical Engineering (SNIBE)

Maglumi2019-nCoV IgM/IgG

EUA 9/14/2020   Serological

Sherlock Biosciences

Sherlock CRISPR SARS-CoV-2 kit

EUA 5/6/2020  CRISPR
Siemens Healthineers

Atellica IM SARS-CoV-2 Total (COV2T)

EUA 5/29/2020CE mark 5/2020 Serological
Siemens Healthineers

Atellica IM SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020  Serological
Siemens Healthineers

Advia Centaur SARS-CoV-2 Total (COV2T)

 
EUA 5/29/2020CE mark 5/2020 Serological
Siemens Healthineers

Advia Centaur SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020  Serological
Siemens HealthineersDimension EXL SARS-CoV-2 EUA 6/8/2020  Serological
Siemens HealthineersDimension Vista SARS-CoV-2 EUA 6/8/2020  Serological
Siemens Healthineers/Fast Track Diagnostics
Fast Track Diagnostics (FTD) SARS-CoV-2 AssayEUA 5/5/2020CE mark 4/2020 PCR
Snibe DiagnosticsMaglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits CE mark 2/2020 Serological
Snibe Diagnostics

Maglumi SARS-CoV-2 S-RBD IgG kit

 CE mark 8/2020 Serological
Solaris Diagnostics

Solaris Multiplex SARS-CoV-2 Assay

EUA 8/10/2020   PCR
SolGent

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit

EUA 5/21/2020  CE mark 2/2020EUA, Korea Ministry of Food and Drug Safety; Philippines FDAPCR

Sona Nanotech

COVID-19 rapid antigen test

EUA submission pending  Antigen

Sorrento Therapeutics

COVI-Track Diagnostic Test

EUA submission pending  Serological

Specialty Diagnostic (SDI) Laboratories

SDI SARS-CoV-2 Assay

EUA 4/10/2020   PCR
Stanford Health Care Clinical Virology LaboratorySARS-CoV-2 PCR AssayEUA 4/8/2020  PCR
Sugentech

SGTi-flex COVID-19 IgG

EUA 9/3/2020  Serological
SureScreen DiagnosticsSureScreen COVID19 IgM/IgG Rapid Test Cassette CE mark 2020 Serological
Systaaq Diagnostic Products2019-Novel Coronavirus (COVID-19) Real Time PCR Kit CE mark 3/2020 PCR
T2 Biosystems

T2SARS-CoV-2 Panel

EUA 8/31/2020   PCR 
Tataa Biocenter

TATAA GrandPerformance SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
TBG Biotechnology

TBG SARS-CoV-2 IgG/IgM Rapid Test Kit 

EUA 8/31/2020  Serological
TBG Biotechnology

ExProbe SARS-CoV-2 Testing Kit 

EUA 6/10/2020  PCR

Texas Department of State Health Services

Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay

EUA 8/21/2020  PCR
Thermo Fisher Scientific

TaqPath COVID-19 Combo Kit, RT-PCR CE-IVD Kit

EUA 3/13/2020 (Combo kit), amended 3/24/2020, 4/20/2020, 5/9/2020CE mark 3/2020 (CE-IVD kit)Authorization in Australia, Singapore, Taiwan (Combo kit)PCR
TIB Molbiol SyntheselaborSarbecovirus E-gene CE mark 2/2020 PCR
Tide LaboratoriesDTPM COVID-19 RT-PCREUA 6/10/2020  PCR
TNS (BioTNS)COVID-19 RT-PCR Peptide Nucleic Acid (PNA) KitEUA 6/30/2020CE mark 5/2020 PCR
Trax Management ServicesPhoenix Dx 2019-CoVEUA 4/20/2020  PCR

Trax Management Services

Phoenix Dx SARS-CoV-2 Multiplex

EUA 7/13/2020  PCR

UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin

SARS-CoV-2 RNA DETECTR Assay

EUA 7/9/2020  CRISPR

Ultimate Dx Laboratory

UDX SARS-CoV-2 Molecular Assay

EUA 4/20/2020  PCR

University of Alabama at Birmingham Fungal Reference Lab

FRL SARS CoV-2 TestEUA 6/23/2020  PCR

University of Arizona Genetics Core for Clinical Services

COVID-19 ELISA pan-Ig Antibody Test 

EUA 8/31/2020  Serological

University of California San Diego Health

UCSD RC SARS-CoV-2 Assay

EUA 7/31/2020  PCR

University of North Carolina Medical Center

UNC Health SARS-CoV-2 real-time RT-PCR test

 
EUA 4/10/2020   PCR

University of Texas MD Anderson Cancer Center Molecular Diagnostics Laboratory

MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay

EUA 6/25/2020  PCR

UTMG Pathology Laboratory

UTHSC/UCH SARS-CoV-2-RT-PCR Assay

EUA 5/3/2020   PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test v2.0

EUA 9/22/2020

CE mark 7/2020

 PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test

EUA 8/5/2020

CE mark 4/2020

Singapore Health Sciences Authority provisional authorization

PCR

Veredus Laboratories

VereCoV Detection Kit 

 CE mark 3/2020

Singapore Health Sciences Authority provisional authorization 2/2020

PCR

Verily Life Sciences

Verily COVID-19 RT-PCR TestEUA 9/8/2020  PCR

Vibrant America Clinical Labs

Vibrant COVID-19 Ab AssayEUA 6/4/2020  Serological

Viracor Eurofins

Viracor SARS-CoV-2 assayEUA 4/6/2020  PCR

Visby Medical

Visby Medical COVID-19EUA 9/16/2020  PCR

Vision Medicals

SARS-CoV-2 Clinical Sequencing assay CE mark 3/2020 PCR

Wadsworth Center, New York Department of Health

New York SARS-CoV Microsphere Immunoassay for Antibody Detection

EUA 4/30/2020   Serological

Warrior Diagnostics

Warrior Diagnostics SARS-CoV-2 Assay

EUA 6/9/2020  PCR

Wren Laboratories

Wren Laboratories COVID-19 PCR Test

EUA 8/3/2020  PCR

Xiamen Biotime Biotechnology

Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test

EUA 7/24/2020  Serological

Xiamen Wiz Biotech

Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2

 CE mark 3/2020 Serological

Xiamen Zeesan Biotech

SARS-CoV-2 Test Kit (Real-time PCR)

EUA 7/31/2020   PCR

Yale New Haven Hospital Clinical Virology Laboratory

SARS-CoV-2 PCR test

EUA 3/31/2020  PCR

Yale School of Public Health

SalivaDirect

EUA 8/15/2020  PCR

YD Diagnostics

MolecuTech Real-Time COVID-19

EUA submission pendingCE mark 3/2020India 4/2020PCR

Yourgene Health

Clarigene SARS-CoV-2 CE mark 8/2020 PCR

Zhejiang Orient Gene Biotech

Coronavirus Ag Rapid Test Cassette CE mark 7/2020 Antigen

Zhejiang Orient Gene Biotech

COVID-19 IgG/IgM Rapid Test Cassette CE mark 4/2020 Serological

Zhejiang Orient Gene Biotech

Coronavirus Detection Kit  CE mark 4/2020 PCR

Zhejiang Orient Gene Biotech

2019-nCoV and SARS-CoV Detection Kit CE mark 4/2020 PCR

Zhejiang Orient Gene Biotech

SARS-CoV-2 Detection Kit CE mark 4/2020 PCR

ZhuHai Sinochips Bioscience

COVID-19 Nucleic Acid RT-PCR Test Kit

EUA 8/17/2020   PCR

Zymo Research

Quick SARS-CoV-2rRT-PCR Kit

EUA 5/7/2020 CE mark 7/2020 PCR

BillionToOne's assay detects SARS-CoV-2 in samples from nasal, nasopharyngeal, and oropharyngeal swabs and has a testing capacity of 1 million tests per day.

The company's host-response diagnostics read the immune system using a machine learning algorithm and multiple mRNA biomarkers.

Over six months, Abbott and SD Biosensor will provide rapid antigen tests to a variety of countries at a maximum price of $5 per test.

The firm said being able to test asymptomatic people with its Panther Fusion SARS-CoV-2 assay could play an important role in reopening the economy.

The firm's single-step pooling approach, which can be used in areas with high disease prevalence, allows labs to multiply their testing capacity.

The test, which is also CE marked, is designed to run on the company's MosaiQ platform for blood grouping and transfusion-transmitted infection screening.

The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.

The test will be designed to run on a portable device that can ultimately be rolled out to point-of-need settings such as doctors' offices and workplaces.

The assay should have a CE-IVD mark by November and will serve the Finnish molecular diagnostics firm's growing European client base.

The lateral flow immunoassay is designed to rapidly detect and differentiate immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma.

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