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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: Jan. 26, 2021

 

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, reissued 12/17/2020

    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

SARS-CoV-2 IgG II Quant antibody test

  CE mark 12/2020   Serological
Abbott

AdviseDx SARS-CoV-2 IgM

EUA 10/9/2020     Serological
Abbott

BinaxNOW COVID-19 Ag Card

EUA 8/26/2020, reissued 12/16/2020

    Antigen
Abbott SARS-CoV-2 IgG test

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

    Serological
Abbott ID Now COVID-19 EUA 3/27/2020     Isothermal amplification
Abbott Abbott RealTime SARS-CoV-2 EUA test EUA 3/18/2020     PCR

Access Bio

CareStart COVID-19 Antigen test

EUA 10/8/2020 CE mark 9/2020   Antigen

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

Acon Laboratories

Acon SARS-CoV-2 IgG/IgM Rapid Test

EUA 12/15/2020     Serological

Acupath Laboratories

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

EUA 6/29/2020     PCR

ADS Biotec

COVID-19 Rapid Antigen Test

CE mark 1/2021 Antigen

Advaite

RapCov Rapid COVID-19 Test

EUA 1/11/2021 Serological

Advanced Biological Laboratories

UltraGene Combo2Screen SARS-CoV-2 assay

  CE mark 5/2020   PCR

Aeon Global Health

Aeon Global Health SARS-CoV-2 Assay

EUA 9/30/2020     PCR 

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

Vstrip COVID-19 Antigen Rapid Test

  CE mark 12/2020

Taiwan EUA 8/2020

Indian Council of Medical Research validation 9/2020

Singapore Health Sciences Authority provisional authorization 12/2020

Antigen

Agena Bioscience

MassArray SARS-CoV-2 Panel

EUA 10/26/2020 CE mark 9/2020   Mass spectrometry

AIT Laboratories

SARS-CoV-2 Assay

EUA 4/24/2020     PCR
Akron Children's Hospital

Akron Children's Hospital SARS-CoV-2 Assay

EUA 9/29/2020     PCR
Akston Biosciences

AntiCoV-ID IgG ELISA

EUA submission pending     Serological
Alimetrix

Alimetrix SARS-CoV-2 RT-PCR Assay

EUA 9/30/2020     PCR, microarray
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 4/22/2020 CE mark 4/2020   PCR
Ambry Genetics

Ambry COVID-19 RT-PCR Test

EUA 1/22/2021

PCR
AMSBIO

A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit

EUA submission pending CE mark 7/2020

Korea Ministry of Food and Drug Safety EUA 7/2020

Philippines FDA 9/2020

PCR
Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit   CE mark 2/2020   PCR

AniCon Labor

Kylt SARS-CoV-2Complete RTU

  CE mark 6/2020   PCR

Applied BioCode

BioCode SARS-CoV-2 Assay

EUA 6/15/2020, reissued 12/7/2020     PCR

Applied DNA Sciences

Linea COVID-19 RT-PCR test

EUA 5/13/2020     PCR
ArcDia International MariPOC 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 authorization PCR

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 Diagnostics Anti-SARS-CoV-2 Rapid Test

EUA 4/24/2020

EUA revoked 8/6/2020

CE mark   Serological
Avellino Lab Avellino 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 IgM

EUA 10/8/2020 CE mark 11/2020   Serological

Beckman Coulter

Access SARS-CoV-2 IgG

EUA 6/26/2020 CE 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 ELISA EUA 8/5/2020     Serological

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab Rapid Test

EUA 7/10/2020     Serological
Beroni Group

SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)

  CE mark 12/2020   Antigen
Beroni Group SARS-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
BGI Real-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoV EUA 3/26/2020 CE mark 3/2/2020 China NMPA 1/2020 PCR

BillionToOne

qSanger-COVID-19 Assay

EUA 9/4/2020     Sequencing

Binx Health

Binx Health At-Home Nasal Swab COVID-19 Sample Collection Kit

EUA 10/20/2020     Collection kit

Biocan Diagnostics

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

EUA 8/25/2020     Serological

Biocartis

Idylla SARS-CoV-2 Test EUA submission pending CE mark 11/2020   PCR

Biocerna

SARS-CoV-2 Test EUA 4/28/2020     PCR

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM Antibody Test Kit EUA 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 Test EUA 8/17/2020     Serological

Biocollections Worldwide

Biocollections Worldwide SARS-Co-V-2 Assay EUA 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

BioGx

Xfree COVID-19 Direct RT-PCR test

EUA submission pending     PCR

Biohit Healthcare (Hefei)

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

EUA 6/18/2020 CE mark 3/2020   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 Rapid Antigen Test

CE mark 1/2021 Antigen
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
BioMérieux Vidas anti-SARS-CoV-2 IgG test EUA 8/6/2020 CE mark 5/2020   Serological
BioMérieux

SARS-COV-2 RESPI R-GENE test

  CE mark 12/2020   PCR
BioMérieux 

SARS-COV-2 R-GENE test

EUA 5/6/2020 CE mark 4/10/2020   PCR

BioMérieux/BioFire Defense

BioFire COVID-19 test

EUA 3/23/2020, reissued 12/4/2020     PCR
BioMérieux/BioFire Diagnostics

BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)

EUA 10/2/2020     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 RV1 Multiplex Kit

  CE mark 11/2020   PCR
Bioneer

AccuPower RV1 Real-Time RT-PCR Kit

  CE mark 11/2020   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 Reliance SARS-CoV-2 RT-PCR Assay Kit

EUA 1/15/2021 PCR
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
BioSewoon Real-Q 2019-nCoV Detection Kit EUA 7/9/2020     PCR
Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) Childrens-Altona-SARS-CoV-2 assay EUA 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, reissued 10/23/2020, reissued 12/18/2020     PCR

Bruker

FluoroType SARS-CoV-2/Flu/RSV panel

  CE mark 12/2020   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
Celltrion

Sampinute COVID-19 Antigen MIA

EUA 10/23/2020     Antigen
Centers for Disease Control and Prevention CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) EUA 2/4/2020, amended 3/15/2020, reissued 12/1/2020     PCR
Centers for Disease Control and Prevention

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

EUA 7/2/2020     PCR
Centogene

CentoSure SARS-CoV-2 RT-PCR Assay

EUA 9/29/2020     PCR
Centogene

SARS-CoV-2 RT-PCR test

EUA 7/1/2020     PCR
Cepheid

Xpert Xpress SARS-CoV-2 DoD

EUA 12/23/2020     PCR
Cepheid

Xpert Omni SARS-CoV-2

EUA 11/27/2020     PCR
Cepheid

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

EUA 9/24/2020  CE mark 11/2020   PCR
Cepheid

Xpert Xpress SARS-CoV-2 test

EUA 3/20/2020     PCR
CerTest BioTec

Viasure SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit

  CE mark 10/2020 on BD Max system   PCR
CerTest BioTec ViaSure SARS-CoV-2 Real Time PCR Detection Kit   CE mark 3/2020 on 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 test EUA 4/2/2020     PCR

ChromaCode

HDPCR SARS-CoV-2 real-time PCR assay EUA 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 Enterprise

EmpowerDX At-Home COVID-19 PCR Test Kit

EUA 10/15/2020     Collection kit
Clinical Reference Laboratory

CRL Rapid Response

EUA 7/30/2020     Molecular
Co-Diagnostics

Logix Smart SARS-CoV-2 Multi-Gene Test

  CE mark 11/2020   PCR
Co-Diagnostics

Logix Smart ABC Assay

  CE mark 11/2020   PCR
Co-Diagnostics

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020 CE 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, reissued 11/2/2020     Isothermal amplification

Columbia University Laboratory of Personalized Genomic Medicine

Triplex CII-CoV-1 rRT-PCR Test

EUA 5/12/2020     PCR
Compass Laboratory Services Compass Laboratory Services SARS-CoV2 Assay EUA 7/13/2020     PCR, Home Collection
Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay EUA 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 Biomedical

VitaPCR Influenza A&B/SARS-CoV-2 assay

  CE mark 10/2020   PCR
Credo Diagnostics Biomedical VitaPCR SARS-CoV2 Assay   CE mark 3/2020 Singapore 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 pending CE 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 4/8/2020 CE mark 3/2020   PCR
Diagnostics Development Hub Fortitude Kit 2.0E     Singapore Health Sciences Authority provisional authorization 2/2020 PCR
Diagnostic Solutions Laboratory DSL COVID-19 Assay EUA 6/25/2020     PCR
DiaSorin

Liaison SARS-CoV-2 Ag

  CE mark 10/2020   Antigen
DiaSorin

Diasorin Liaison SARS-CoV-2 IgM Assay

EUA 9/29/2020     Serological 
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 Laboratory SARS-CoV-2 PCR Test EUA 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 Genotek/OraSure Technologies

ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100saliva collection devices

EUA 10/28/2020     Collection device

DNA Genotek/OraSure Technologies

Omnigene·Orall OM-505 and OME-505 (Omnigene·Oral) saliva collection devices

EUA 10/14/2020, reissued 10/28/2020     Collection device

DnaNudge

COVID Nudge test

  CE mark 6/2020   PCR

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
EliTech

SARS-CoV-2 Plus ELITe MGB Assay

EUA submission pending     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

SARS-CoV-2 Antigen ELISA

  CE mark 12/2020   Antigen
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2/Influenza A/B

  CE mark 12/2020   PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgG)

EUA 5/4/2020     Serological
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2

EUA 6/8/2020 CE 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, reissued 11/19/2020     PCR

Fluidigm

Advanta Dx SARS-CoV-2 RT-PCR Assay

EUA 8/25/2020 CE mark 1/2021   PCR

Fosun Pharma USA

Fosun COVID-19 RT-PCR Detection Kit

EUA 4/17/2020     PCR
Fulgent Genetics/Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test EUA 5/15/2020     PCR
Fulgent Genetics/MedScan Laboratory COVID-19 EUA submission pending     Sequencing
Genalyte

Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

EUA 10/8/2020     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 pending CE mark 5/2020   PCR
GeneFirst

GeneFirst COVID-19 Detection Kit

  CE mark 4/2020   PCR
GeneFirst

GeneFirst COVID-19 Plus Detection Kit

  CE mark 12/2020   PCR
GeneMatrix

NeoPlex COVID-19 Detection Kit

EUA 5/14/2020     PCR
GeneMe

Fast Reliable Accurate Nucleic Acid-Based Kit for COVID-19 Detection (FRANKD)

  CE mark 5/2020   Isothermal amplification
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 4/2020 Taiwan FDA approval; India Central Drugs Standard Control Organisation approval PCR
Genesprint

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

  CE mark 9/2020   Antigen
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 6/5/2020 CE mark 4/2020   PCR
Genetworx

Genetworx Covid-19 Nasal Swab Test

EUA 12/15/2020     PCR
GenMark Diagnostics

ePlex Respiratory Pathogen Panel 2 (RP2)

EUA 10/8/2020 CE mark 9/2020   PCR
GenMark Diagnostics

ePlex SARS-CoV-2 Test (discontinued)

EUA 3/19/2020     PCR
GenMark Diagnostics eSensor SARS-CoV-2 test EUA submission pending     PCR
Genomica/PharmMar Group 2 kits: qCOVID-19, CLART COVID-19   CE mark 3/2020   PCR

GenScript Biotech

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

EUA 11/6/2020 CE 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 NovaGen SARS-CoV-2 (COVID-19) antigen rapid test

  CE mark 12/2020   Antigen
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 SARS-CoV-2 RT-PCR Assay

EUA 11/23/2020     PCR

Gravity Diagnostics

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

Grifols

Procleix SARS-CoV-2 Assay

  CE mark 5/2020   Isothermal amplification

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

C/Tech SARS-CoV-2 ERT-PCR kit

  CE mark 7/2020   PCR
Hai Kang Life

C/Tech SARS-CoV-2 RT-PCR kit

  CE mark 7/2020   PCR
Hangzhou AllTest Biotech

2019-nCoV IgG/IgM Rapid Test Cassette

EUA submission pending CE mark 2/2020   Serological
Hangzhou Biotest Biotech

RightSign COVID-19 IgG/IgM Rapid Test Cassette

EUA 6/4/2020     Serological
Hayat Genetics

Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit

  CE mark 9/2020   Isothermal amplification
Healgen Scientific

2019-nCoV Direct qPCR Kit

  CE mark 4/2020   PCR
Healgen Scientific COVID-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 Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay EUA 6/23/2020     PCR
Helix Helix COVID-19 NGS Test

EUA 8/6/2020, reissued 10/22/2020

    Sequencing
Helix Helix COVID-19 Test EUA 7/23/2020     PCR
Hologic Panther Fusion SARS-CoV-2 assay EUA 3/16/2020     PCR
Hologic

Aptima SARS-CoV-2/Flu assay

EUA 12/16/2020     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 approval PCR

Innovita (Tangshan) Biological Technology

Innovita 2019-nCoV Ab Test (Colloidal Gold)

 
EUA 11/23/2020     Serological
Integrated DNA Technologies/Danaher IDT 2019-novel coronavirus kit under 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 EUA CE mark 4/2020 Singapore Health Sciences Authority provisional authorization; Philippines FDA PCR
Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test EUA 6/13/2020     PCR
Kantaro Biosciences

COVID-SeroKlir, COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits

EUA 11/25/2020 (COVID-SeroKlir) CE mark 10/2020   Serological
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 7/13/2020 CE mark EUAL, Korea Centers for Disease Control and the Korea Food and Drug Administration PCR

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 Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay EUA 7/6/2020     PCR
Laboratory Corporation of America COVID-19 RT-PCR Test

EUA 3/16/2020, reissued 4/20/2020, 7/24/2020, 9/18/2020, 12/9/2020

    PCR
LetsGetChecked (PrivaPath Diagnostics)

LetsGetChecked Coronavirus (COVID-19) Test

EUA 5/28/2020     PCR
LGC, Biosearch Technologies

Biosearch Technologies SAR-CoV-2 Real-Time and End-Point RT-PCR Test

EUA submission pending     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
Lucira Health

Lucira COVID-19 All-In-One Test Kit

EUA 11/17/2020     LAMP
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

Luminostics

Clip COVID Rapid Antigen Test

EUA 12/7/2020     Antigen

LumiraDx

LumiraDx SARS-CoV-2 RNA STAR Complete

EUA 10/14/2020     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
MatMaCorp

MatMaCorp COVID-19 2SF Test

EUA 12/17/2020     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
MedMira REVEALCOVID-19 total antibody test EUA submission pending CE mark 5/2020   Serological
Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit EUA 7/17/2020     Serological
Meridian Bioscience Revogene SARS-CoV-2 test EUA submission pending     PCR
Mesa Biotech Accula SARS-CoV-2 test EUA 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

Mologic

COVID-19 Rapid Antigen Test

  CE mark 12/2020   Antigen

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 authorization Serological

Nal von minden

Nadal COVID-19 IgG/IgM test

  CE mark 3/2020   Serological

NanoEntek America

Frend COVID-19 Total Ab

EUA 9/29/2020     Serological

National Jewish Health

SARS-CoV-2 MassArray Test

EUA 9/29/2020     PCR and mass spectrometry

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 3/30/2020 CE mark 5/2020   PCR

NGeneBio

NGenePlex nCoV qRT-PCR kit

EUA submission pending CE mark 7/2020   PCR

Nirmidas Biotech

Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit

EUA 9/29/2020     Serological

Nirmidas Biotech

MidaSpot COVID-19 Antibody Combo Detection Kit

EUA 12/31/2020     Serological

Northwestern Medicine Diagnostic Molecular Laboratory

SARS-Cov-2 Assay

EUA 4/2/2020     PCR
Novacyt/Primerdesign COVID-19 Genesig Real-Time PCR assay EUA 3/20/2020 CE mark 2/2020

EUA, India 3/26/2020

Thailand Ministry of Health, 4/2/2020

PCR
NowDiagnostics AdexusDx 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

Omixon/SeqOnce Biosciences

AzureSeq-200 RT-PCR kit

  CE mark 10/2020   PCR

One Health Laboratories

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

EUA 5/13/2020     PCR

Operon

Simple/Stick Ag SARS-CoV-2

CE mark 15/1/2021 Antigen

Operon

Real SARS-CoV-2 CE mark 12/2020 PCR

Operon

Real SARS-CoV-1/2
  CE mark 10/2020   PCR

OpGen

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

Opti Medical Systems

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

Optolane Technologies

Kaira 2019-nCoV Detection kit

EUA 9/1/2020 CE mark 4/2020   PCR

Orig3n

Orig3n 2019 Novel Coronavirus (COVID-19) Test

EUA 4/10/2020     PCR

Ortho Clinical Diagnostics

Vitros SARS-CoV-2 Antigen test

EUA 1/10/2021 CE mark 11/2020   Antigen

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 Healthcare GeneFinder COVID-19 Plus RealAmp Kit EUA 4/18/2020 CE mark 2/2020   PCR
Oxford Nanopore Technologies

LamPore

  CE mark 10/2020   LAMP, sequencing
P23 Labs

P23 Labs TaqPath SARS-CoV-2 Assay

EUA 5/21/2020, reissued 10/20/2020

    PCR
PacificDx (ResearchDx) PacificDx Covid-19 Test EUA 12/11/2020     PCR
PathoFinder RespiFinder 2Smart kit   CE mark 11/2020   PCR
PathoFinder

RealAccurate Quadriplex (RAQ) Flu/COVID-19 PCR kit

  CE mark 11/2020   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

PKamp Respiratory SARS-CoV-2 RT-PCR Panel

  CE mark 10/2020   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 SARS-CoV-2 RT-PCR Asssay

  CE mark 11/2020   PCR
PerkinElmer

SARS-CoV-2 RT-qPCR Reagent Kit

  CE mark 4/2020   PCR
PerkinElmer

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020, reissued 10/28/2020     PCR
Phadia (Thermo Fisher Scientific)

EliA SARS-CoV-2-Sp1 IgG Test

EUA 1/11/2021 Serological
Phosphorus Diagnostics

Phosphorus COVID-19 RT-qPCR Test

EUA 6/4/2020, reissued 12/15/2020     PCR
PlexBio

IntelliPlex SARS-CoV-2 Detection Kit

EUA 6/25/2020 CE 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

Progenika Biopharma/Grifols

Anti-SARS-CoV-2 (IgG) ELISA Kit

  CE mark 9/2020   Serological
Pro-Lab Diagnostics

Pro-AmpRT SARS-CoV-2 Test

EUA 8/13/2020     Isothermal amplification
ProterixBio SARS-CoV-2 (RBD) IgG Antibody test EUA submission pending     Serological
Psomagen Psoma COVID-19 RT Test EUA 6/30/2020     PCR
QDx Pathology Services QDX SARS-CoV-2 Assay EUA 8/25/2020     PCR
Qiagen QiaStat-Dx Respiratory SARS-CoV-2 Panel EUA 3/30/2020 CE mark 3/2020   PCR
Quadrant Biosciences

Clarifi COVID-19 Test Kit

EUA 9/22/2020     PCR

Quansys Biosciences

Q-Plex SARS-CoV-2 Human IgG (4 Plex)

EUA 10/28/2020     Serological
Quanterix

Simoa SARS-CoV-2 N Protein Antigen Test

EUA 1/5/2021     Antigen
Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test EUA 12/23/2020     Serological
QuantuMDx SARS-CoV-2 RT-PCR Detection Assay EUA submission pending CE mark 6/2020   PCR
Quest Diagnostics Infectious Disease

Quest Diagnostics RC COVID-19 +Flu RT-PCR

EUA 12/4/2020     PCR
Quest Diagnostics Infectious Disease Quest Diagnostics HA SARS-CoV-2 EUA 7/15/2020     PCR
Quest Diagnostics Infectious Disease Quest Diagnostics RC SARS-CoV-2 Assay

EUA 7/15/2020, reissued 11/27/2020

    PCR
Quest Diagnostics Infectious Disease Quest Diagnostics PF SARS-CoV-2 Assay EUA 7/15/2020     PCR
Quest Diagnostics Coronavirus Disease 2019 (COVID-19) Test EUA 3/17/2020, reissued 7/18/2020     PCR
Quidel

Solana SARS-CoV-2 Assay

EUA 12/23/2020     Isothermal amplification
Quidel

QuickVue SARS Antigen test

EUA 12/18/2020     Antigen
Quidel

Sofia 2 Flu + SARS Antigen FIA

EUA 10/2/2020     Antigen
Quidel Sofia 2 SARS Antigen FIA EUA 5/8/2020 CE mark 7/2020   Antigen
Quidel Lyra SARS-CoV-2 Assay EUA 3/17/2020, amended 3/23/2020 CE mark 3/2020   PCR

Quidel

Lyra Direct SARS-CoV-2 Assay

EUA 5/18/2020 CE mark 5/2020   PCR

Quotient Limited/Quotient Suisse

MosaiQ COVID-19 Antibody Magazine

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

RapidRona

RapidRona Self-Collection Kit

EUA 11/23/2020     Collection Kit

R-Biopharm

Rida Gene SARS-CoV-2

  CE mark 5/2020   PCR

Rendu Biotechnology

2019-nCoV detection kit

    China NMPA 3/2020 Isothermal amplification
Rheonix Rheonix COVID-19 MDx Assay EUA 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 S

EUA 11/25/2020     Serological
Roche

Elecsys Anti-SARS-CoV-2

EUA 5/2/2020     Serological
Roche Cobas SARS-CoV-2 Test

EUA 3/12/2020, reissued 10/15/2020

CE 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

AQ-TOP COVID-19 Rapid Detection Kit Plus

EUA 10/5/2020     Isothermal amplification
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
Seegene

Allplex SARS-CoV-2/FluA/FluB/RSV Assay

  CE mark 9/2020   PCR
Seegene Allplex 2019-nCoV Assay EUA 4/21/2020 CE mark 2/2020 EUA, Korea Ministry of Food and Drug Safety PCR

Sentinel Diagnostics

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

SeqOnce Biosciences

AzureSeq SARS-CoV-2 RT-qPCR Kit EUA submission pending     PCR

Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical

 

novel coronavirus nucleic acid detection kit

  CE mark 3/2020 China NMPA 3/2020 PCR

Shanghai GeneSc Biotech

LAMP Based Coronavirus 2019-nCoV Rapid Detection Kit

CE mark 9/2020 Isothermal amplification

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
Shuwen Biotech

SARS-COV-2 RT-PCR Kit

  CE mark 1/2021   PCR
Siemens Healthineers

Dimension EXL SARS‑CoV‑2 IgG (CV2G)

EUA 1/8/2021 Serological
Siemens Healthineers

Dimension EXL SARS‑CoV‑2 IgG (COV2G)

EUA 1/8/2021 Serological
Siemens Healthineers

SARS-CoV-2 IgG Antibody Test

EUA submission pending CE mark 11/2020   Serological
Siemens Healthineers

Clinitest Rapid COVID-19 Antigen Test

  CE mark 10/2020   Antigen
Siemens Healthineers

Atellica IM SARS-CoV-2 Total (COV2T)

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

Advia Centaur SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020     Serological
Siemens Healthineers Dimension EXL SARS-CoV-2  EUA 6/8/2020     Serological
Siemens Healthineers Dimension Vista SARS-CoV-2  EUA 6/8/2020     Serological
Siemens Healthineers/Fast Track Diagnostics
Fast Track Diagnostics (FTD) SARS-CoV-2 Assay EUA 5/5/2020 CE mark 4/2020   PCR
SML Genetree

Ezplex SARS-CoV-2 G Real-Time PCR Kit

EUA 1/13/2021 PCR
Snibe Diagnostics Maglumi SARS-CoV-2 Neutralizing Antibody Assay CE mark 1/2021 Serological
Snibe Diagnostics Maglumi 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 2/2020 EUA, Korea Ministry of Food and Drug Safety; Philippines FDA PCR

Sona Nanotech

COVID-19 rapid antigen test

EUA submission pending CE mark 12/2020   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
Spectrum Solutions SDNA-2000, SDNA-3000 Saliva Collection Devices   CE mark 1/2021   Collection device
Spectrum Solutions SDNA-1000 Saliva Collection Device EUA 10/8/2020     Collection device
Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 PCR Assay

EUA 4/8/2020, reissued 11/24/2020

    PCR
Sugentech

SGTi-flex COVID-19 IgG

EUA 9/3/2020     Serological
SureScreen Diagnostics SureScreen COVID19 IgM/IgG Rapid Test Cassette   CE mark 2020   Serological
Sysmex

HISCL SARS-CoV-2 Ag Reagent

   

Japan IVD approval for manufacturing and marketing

Antigen
Systaaq Diagnostic Products 2019-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 CE mark 5/2020  India CDSCO 10/2020 Serological
TBG Biotechnology

ExProbe SARS-CoV-2 Testing Kit 

EUA 6/10/2020 CE mark 5/2020  Taiwan FDA 7/2020, India CDSCO 10/2020 PCR

Tempus Labs

iC SARS-CoV2 Test

EUA 10/1/2020     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

EliA SARS-CoV-2-Sp1 IgG test

  CE mark 10/2020   Serological
Thermo Fisher Scientific

OmniPath COVID-19 Total Antibody ELISA Test

EUA 10/2/2020 CE mark 10/2020   Serological
Thermo Fisher Scientific

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

EUA 3/13/2020 (Combo kit), reissued 10/9/2020 CE mark 3/2020 (CE-IVD kit) Authorization in Australia, Singapore, Taiwan (Combo kit) PCR
TIB Molbiol Syntheselabor Sarbecovirus E-gene   CE mark 2/2020   PCR
Tide Laboratories DTPM COVID-19 RT-PCR EUA 6/10/2020     PCR
TNS (BioTNS) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit EUA 6/30/2020 CE mark 5/2020   PCR
Trax Management Services Phoenix Dx 2019-CoV EUA 4/20/2020     PCR

Trax Management Services

Phoenix Dx SARS-CoV-2 Multiplex

EUA 7/13/2020     PCR

Trinity Biotech

Captia(TM) SARS-CoV-2 IgG ELISA

  CE mark 1/2021   Serological

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

UMass Memorial Medical Center

UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel

EUA 10/1/2020     PCR

United Biomedical

UBI SARS-CoV-2 ELISA EUA 1/15/2021 Serological

University of Alabama at Birmingham Fungal Reference Lab

FRL SARS CoV-2 Test EUA 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, Los Angeles

UCLA SwabSeq COVID-19 Diagnostic Platform

EUA 10/6/2020     PCR

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

ZeroPrep Saliva Collection Kit and extraction-free VereRT ZeroPrep COVID-19 PCR Kit

    Singapore Health Sciences Authority provisional authorization 12/2020 PCR
Veredus Laboratories

VereCoV OneMix Detection Kit

  pending Singapore Health Sciences Authority provisional authorization 10/2020 PCR, microarray
Veredus Laboratories

VereRT COVID-19 PCR Kit (previously VereRTCoV SARS-CoV-2 Real-Time RT-PCR)

  CE mark 6/2020 (pending for updated product) Singapore Health Sciences Authority provisional authorization 6/2020 PCR

Veredus Laboratories

VereRT ZeroPrep COVID-19 PCR Kit (previously VereRTCoV 3.0 ZeroStep Real-Time RT-PCR)

  CE mark 8/2020 (old product name) Singapore Health Sciences Authority provisional authorization 8/2020 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 Test

EUA 9/8/2020, reissued 12/18/2020

    PCR

Vibrant America Clinical Labs

Vibrant COVID-19 Ab Assay EUA 6/4/2020     Serological

Viracor Eurofins

Viracor SARS-CoV-2 assay EUA 4/6/2020     PCR

Visby Medical

Visby Medical COVID-19 EUA 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, reissued 10/20/2020

    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, reissued 8/28/2020, reissued 12/16/2020

    PCR

YD Diagnostics

MolecuTech Real-Time COVID-19

EUA submission pending CE mark 3/2020 India 4/2020 PCR

Yourgene Health

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

Zeus Scientific

Zeus ELISA SARS-CoV-2 IgG Test System

EUA 10/6/2020     Serological

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 Lituo Biotechnology

COVID-19 Antigen Detection Kit (Colloidal Gold)

  CE mark 7/2020   Antigen

ZhuHai Sinochips Bioscience

COVID-19 Nucleic Acid RT-PCR Test Kit

EUA 8/17/2020     PCR

Zymo Research

Quick SARS-CoV-2 Multiplex Kit

  CE mark 11/2020   PCR

Zymo Research

Quick SARS-CoV-2rRT-PCR Kit

EUA 5/7/2020 CE mark 7/2020   PCR

While SARS-CoV-2 test demand will likely remain strong well into 2021, the question of what to do with the built-up capacity in a post-COVID-19 environment looms.

The prizes were awarded to software and digital tools that were directly integrated with COVID-19 testing to automate data reporting.

Toronto-based DMark Biosciences will provide the UgenTec FastFinder PCR analysis software to molecular diagnostic labs across Canada.

MeMed believes its tests can be used to identify which COVID-19 patients require more aggressive treatment with corticosteroids.

The firm claims a rapid isothermal test has an LoD of 20 viral copies per milliliter while a saliva-based PCR test has an LoD of 2 copies per milliliter.

The PCR-based panel is designed to simultaneously detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus, with results in less than two hours.

The companies will each contribute resources to the initiative, which is focused on increasing SARS-CoV-2 testing capacity in the Netherlands.

The immunoassay detects and differentiates antibodies against SARS-CoV-2 in serum, plasma, and whole blood with results available in 20 minutes.

Genetworx and PacificDx's tests detect SARS-CoV-2 nucleic acid, while Hologic's test can also detect and differentiate SARS-CoV-2 and influenza A and B.

On its weekly call, the agency also stressed the importance of reporting test results, including those from home-based tests, to public health authorities.

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