Close Menu

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 use. Links to primary regulatory decisions are provided where available.

Last updated: April 8, 2020.

 

EUA: Emergency Use Authorization

EUA submission pending: FDA requires labs and commercial manufacturers to submit EUA within 15 days of test launch

EUA not required: FDA allows commercial manufacturers to launch serology tests without an EUA

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

*See US FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

Company/Organization
Name
Test NameUS Regulatory Status*EU Regulatory StatusAsia Regulatory StatusTechnology
3D Medicines

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


 CE mark 3/2020  PCR
AbbottID Now COVID-19EUA 3/27/2020  isothermal amplification
AbbottAbbott RealTime SARS-CoV-2 EUA testEUA 3/18/2020   PCR
Anatolia GeneworksBosphore Novel Coronavirus (2019-nCoV) Detection Kit CE mark 2/2020  PCR
ARUP LaboratoriesCOVID-19EUA submission pending   PCR
A*STAR,Tan Tock Seng Hospital of SingaporeA*STAR Fortitude 2.0  Singapore Health Sciences Authority, provisional authorization for clinical use PCR
Assure Tech

COVID-19 IgG/IgM Rapid Test Device

EUA not required  Serological
AusDiagnostics

AusDiagnostics SARS-CoV-2, influenza, RSV panel

 CE mark 3/2020 PCR
Autobio DiagnosticsAnti-SARS-CoV-2 Rapid TestEUA not required  Serological
Avellino LabAvellino SARS-CoV-2/COVID-19 (AvellinoCoV2)EUA 3/25/2020   PCR

Becton Dickinson, BioGx

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

EUA 4/2/2020   PCR
Beijing Decombio BiotechnologyNovel Coronavirus IgM/IgG Combo Rapid Test-CassetteEUA not required  Serological
Beijing Diagreat Biotechnologies

2019-nCoV IgG, IgM Antibody Determination Kits

2019-nCoV IgG/IgM Antibody Rapid Test Kit

EUA not required  Serological
Beijing Kewei Clinical Diagnostic ReagentGenonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test KitEUA not required  Serological
Beijing O&D BiotechCoronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold)EUA not required  Serological
Beroni GroupSARS-CoV-2 IgG/IgM Antibody Detection KitEUA not requiredCE mark 4/2020 Serological
BGIReal-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoVEUA 3/26/2020CE mark 3/2/2020China NMPA 1/2020 PCR

Biodesix

 

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

EUA submission pending   PCR

BioMedomics

COVID-19 IgM-IgG Rapid Test

EUA not required  Serological

BioMérieux/BioFire Defense

BioFire COVID-19 test

EUA 3/23/2020   PCR
Bioneer

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

 CE mark PCR
BioReference Laboratories

Novel Coronavirus COVID-19

EUA submission pending   PCR
BTNXRapid Response COVID-19 IgG/IgM Test CassetteEUA not required  Serological
Cellex

qSARS-CoV-2 IgG/IgM Rapid Test

EUA 4/1/2020  Serological
Centers for Disease Control and Prevention (performed at qualified high-complexity CLIA laboratories designated by CDC)CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)EUA 2/4/2020, amended 3/15/2020  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 Diagnostic SystemsDDP COVID-19 IgM/IgG SystemEUA not required  Serological

Children’s Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

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

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020CE mark 2/2020  PCR
Core Technology CoreTest COVID-19 IgM/IgG Ab TestEUA not required  Serological
Credo Diagnostics BiomedicalVitaPCR SARS-CoV2 Assay CE mark 3/2020  PCR
DiaCarta

QuantiVirus SARS-CoV-2 test

EUA submission pendingCE mark 3/2020  PCR
Diagnostic Solutions LaboratoryCOVID-19 AssayEUA submission pending   PCR
DiaSorin Molecular

Simplexa COVID-19 Direct

EUA 3/19/2020   PCR
Diatherix EurofinsCOVID-19 PanelEUA submission pending   PCR
Diazyme Laboratories

Diazyme DZ-LITE SARS-CoV-2 IgG, IgM CLIA Kits

EUA not required  Serological
Eachy Biopharmaceuticals

AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)

EUA not required  Serological
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2

 CE mark 3/2020 PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISAs (IgA and IgG)

 CE mark 3/2020 Serological
Fulgent Genetics/MedScan LaboratoryCOVID-19EUA submission pending  Sequencing
Genetic Signatures

EasyScreen SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
Genetron

Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing)

 CE 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

Gnomegen

Gnomegen COVID-19 RT-Digital PCR Detection Kit

EUA 4/6/2020   PCR
Guangzhou Wondfo Biotech SARS-CoV-2 Antibody Test EUA not required  Serological
Hangzhou AllTest BiotechAllTest 2019-nCoV IgG/IgM Rapid Test Cassette, AllTest COVID IgG/IgM Rapid Test DipstickEUA not required  Serological
Hangzhou Biotest Biotech COVID-19 IgG/IgM Rapid Test Cassette EUA not required  Serological
Hangzhou Clongene Biotech Clungene COVID-19 IgM/IgG Rapid Test Cassette EUA not required  Serological
Hangzhou Testsealabs Biotechnology

One Step SARS-CoV2 (COVID-19) IgG/IgM Test

EUA not required   Serological
Healgen Scientific COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) EUA not required  Serological
HologicPanther Fusion SARS-CoV-2 assayEUA 3/16/2020   PCR
InBios International

Smart Detect SARS-CoV-2 rRT-PCR Kit

 EUA 4/7/2020   PCR
Innovita (Tangshan) Biological Technology 2019-nCoV Ab Test (Colloidal Gold) EUA not required  Serological
Integrated DNA Technologies/DanaherIDT 2019-novel coronavirus kitunder CDC's EUA
   PCR
Ipsum Diagnostics

COV-19 IDx assay

EUA 4/1/2020  PCR
Jiangsu Macro & Micro-Test Med-Tech

SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)

EUA not required  Serological
JN MedsysProTect Covid-19 kit  Singapore Health Sciences Authority, provisional authorization for clinical usePCR
Kogene Biotech2019 Novel Coronavirus Real-time PCR Kit CE markEUAL, Korea Centers for Disease Control and the Korea Food and Drug Administration PCR
Laboratory Corporation of AmericaLabCorp 2019 Novel Coronavirus testEUA 3/16/2020   PCR
LGC, Biosearch Technologies

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

under CDC's EUA   PCR
Lifeassay Diagnostics

Test-it COVID-19 IgM/IgG Lateral Flow Assay

EUA not required  Serological
Luminex

ARIES SARS-CoV-2 Assay

EUA 4/3/2020  PCR
Luminex

NxTAGCoV Extended Panel Assay

EUA 3/27/2020  PCR

Massachusetts General Hospital

MGH COVID-19 qPCR assay

EUA 4/3/2020   PCR
Medical Systems Biotechnology

Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit

EUA not required  Serological
Mesa BiotechAccula SARS-CoV-2 testEUA 3/23/2020   PCR

Nanjing Liming Bio-products

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

EUA not required  Serological

NanoResearch

NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test

EUA not required  Serological

Nantong Diagnos Biotechnology

(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)

EUA not required  Serological

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020   PCR
Nirmidas Biotech

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

EUA not required  Serological

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
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
OsangHealthcareGeneFinder COVID-19 RealAmp KitEUA submission pendingCE mark 2/2020  PCR
PCL

COVID19 IgG/IgM Rapid Gold

EUA not required  Serological
PerkinElmer

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020CE mark 3/2020  PCR
PhamatechCOVID19 IgG/IgM Rapid TestEUA not required  Serological
PromedicalCOVID-19 Rapid Test, Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)EUA not required  Serological
QiagenQiaStat-Dx Respiratory SARS-CoV-2 PanelEUA 3/30/2020CE mark 3/2020  PCR
Quest DiagnosticsCoronavirus Disease 2019 (COVID-19) TestLab test, EUA 3/17/2020   PCR
QuidelLyra SARS-CoV-2 AssayEUA 3/17/2020, amended 3/23/2020 CE mark 3/2020Health Canada PCR

Rendu Biotechnology

2019-nCoV detection kit

  China NMPA 3/2020isothermal amplification
RocheCobas SARS-CoV-2 TestEUA 3/12/2020CE mark 2020  PCR

ScienCell Research Laboratories

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

EUA 4/3/2020   
SD BiosensorStandard Q COVID-19 IgM/IgG DuoEUA not required  Serological
SeegeneAllplex 2019-nCoV Assay CE mark 2/2020EUA, Korea Ministry of Food and Drug Safety PCR

Sentinel Diagnostics

STAT-NAT COVID-19 HK kit, B kit CE mark 3/2020  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
Shenzhen Landwind MedicalCOVID-19 IgG/IgM Rapid Test DeviceEUA not required  Serological
Snibe DiagnosticsMaglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits CE mark 2/2020 PCR
SolGent

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit

  CE mark 2/2020EUA, Korea Ministry of Food and Drug Safety; Philippines FDA PCR
Suzhou Kangheshun Medical Technology SARS-CoV-2 IgG/IgM Rapid Test Cassette EUA not required  Serological
Systaaq Diagnostic Products2019-Novel Coronavirus (COVID-19) Real Time PCR Kit CE mark 3/2020  PCR
Telepoint Medical Services

SARS-CoV-2 IgG/IgM Rapid Qualitative Test

EUA not required  Serological
Thermo Fisher Scientific

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

EUA 3/13/2020 (Combo kit), amended 3/24/2020 CE mark 3/2020 (CE-IVD kit) Authorization in Australia, Singapore, Taiwan (Combo kit) PCR
Tianjin Beroni BiotechnologySARS-CoV-2 IgG/IgM Antibody Detection KitEUA not required  Serological
TIB Molbiol SyntheselaborSarbecovirus E-gene CE mark 2/2020  PCR
United BiomedicalUBI SARS-CoV-2 ELISAEUA not required  Serological

Viracor Eurofins

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

Vision Medicals

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

VivaChek Biotech (Hangzhou)

VivaDiag COVID-19 IgM/IgG Rapid Test

EUA not required  Serological

Yale New Haven Hospital Clinical Virology Laboratory

SARS-CoV-2 PCR test

EUA 3/31/2020  PCR

Zhejiang Orient Gene Biotech

COVID-19 IgG/IgM Rapid Test CassetteEUA not required CE mark  Serological

Zhengzhou Fortune Bioscience

IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method)

EUA not required  Serological

Zhongshan Bio-Tech

SARS-CoV-2 IgM/IgG (GICA)

EUA not required  Serological

Zhuhai Encode Medical Engineering

Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device

EUA not required   Serological

Zhuhai Livzon Diagnostics

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

EUA not required   Serological

The company said the COVID-19 pandemic and resulting stay-at-home orders have led to a slowdown in testing service volumes in recent weeks.

The firm plans to submit an EUA application for its quantitative Sanger sequencing COVID-19 test, which could run on hundreds of available CE instruments.

The investment bank said the company's molecular diagnostics have the potential to replace microarrays for cytogenetics analysis.

The assays detect either SARS-CoV-2 antigens or antibodies to SARS-CoV-2 to identify active infections and previous exposure.

PharmaCyte, which develops therapies for cancer and diabetes, will be responsible for development and commercialization of tests based on the technology.

The collaboration includes setting up a new testing laboratory that will investigate the use of alternative chemical reagents for test kits.

Avacta said it is aiming to complete development of Affimer reagents for the COVID-19 test by the end of May.

Starting late March and into its fiscal fourth quarter, social distancing guidelines began significantly impacting test volume trends, the company said.

The real-time PCR test provides results in about four hours and has been validated on Thermo Fisher Scientific and Bio-Rad instruments.

Approximately 80 percent of gross product placements in the quarter were associated with interest in COVID-19 testing, the firm said

Pages