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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: June 3, 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
3D Medicines

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


 CE mark 3/2020 PCR
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

Advanced Biological Laboratories

UltraGene Combo2Screen SARS-CoV-2 assay

 CE mark 5/2020 PCR

AIT Laboratories

SARS-CoV-2 Assay

EUA 4/24/2020  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 submission pending  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

A*STAR,Tan Tock Seng Hospital of Singapore

A*STAR Fortitude 2.0

  Singapore Health Sciences Authority, provisional authorization for clinical usePCR

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 TestEUA 4/24/2020CE 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

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

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
Beroni GroupSARS-CoV-2 IgG/IgM Antibody Detection Kit CE mark 4/2020 Serological
BGIReal-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoVEUA 3/26/2020CE mark 3/2/2020China NMPA 1/2020PCR

Biocerna

SARS-CoV-2 TestEUA 4/28/2020  PCR

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

Biolidics

2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

EUA submission pendingCE mark 4/2020

Singapore Health Sciences Authority provisional authorization; Philippines FDA

Serological

BioMedomics

COVID-19 IgM-IgG Rapid Test

 CE mark 3/2020 Serological
Biomerica

COVID-19 IgG/IgM Rapid Test

 CE mark 5/2020 Serological
BioMérieux

Vidas anti-SARS-CoV-2 IgM test

 CE mark 5/2020 Serological
BioMérieuxVidas anti-SARS-CoV-2 IgG test 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 5/1/2020   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  Serological
BioReference Laboratories

Novel Coronavirus COVID-19

EUA submission pending  PCR
Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL)Childrens-Altona-SARS-CoV-2 assayEUA 4/14/2020  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 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 Diagnostics
DDP COVID-19 IgM/IgG SystemEUA 4/14/2020  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 submission pending  PCR

CirrusDx Laboratories

CirrusDx SARS-CoV-2 Assay

EUA 4/15/2020   PCR
Co-Diagnostics

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020CE mark 2/2020 PCR

Color

Color SARS-CoV-2 LAMP Diagnostic Assay

EUA 5/18/2020  Isothermal amplification

Columbia University Laboratory of Personalized Genomic Medicine

Triplex CII-CoV-1 rRT-PCR Test

EUA 5/12/2020  PCR
Credo Diagnostics BiomedicalVitaPCR SARS-CoV2 Assay CE mark 3/2020Singapore Health Sciences Authority, provisional authorization for clinical usePCR

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  
Dba SpectronRx

Hymon SARS-CoV-2 Test Kit

EUA 5/22/2020  PCR
DiaCarta

QuantiVirus SARS-CoV-2 test kit

EUA 4/8/2020CE mark 3/2020 PCR
Diagnostic Solutions LaboratoryCOVID-19 AssayEUA submission pending  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/IgM CLIA kits

EUA submission pending  Serological
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
Erba Mannheim

ErbaLisa COVID-19 ELISA kits

 CE mark 4/2020 Serological
Eurofins Ingenasa

Ingezim COVID 19 DR

 CE mark 6/2020  Serological
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2

 CE mark 3/2020 PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgG)

EUA 5/4/2020  Serological
Euroimmun/PerkinElmer

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

 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

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
Genedrive

Genedrive 96 SARS-CoV-2 Kit

 CE mark 5/2020 PCR
GeneMatrix

NeoPlex COVID-19 Detection Kit

EUA 5/14/2020  PCR
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

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

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 assaysEUA submission pending
CE mark 4/2020 Serological

Gravity Diagnostics

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

Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory

CDI Enhanced COVID-19 Test

 
EUA 4/15/2020  PCR
Hangzhou AllTest Biotech

2019-nCoV IgG/IgM Rapid Test Cassette

EUA submission pendingCE mark 2/2020 Serological
Healgen Scientific/Zhejiang Orient Gene Biotech

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

EUA 5/29/2020   Serological
HologicPanther Fusion SARS-CoV-2 assayEUA 3/16/2020  PCR
Hologic

Aptima SARS-CoV-2 assay

EUA 5/14/2020  PCR
InBios International

Smart Detect SARS-CoV-2 rRT-PCR Kit

EUA 4/7/2020  PCR
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

JN Medsys

ProTect Covid-19 kit

 CE mark 4/2020Singapore Health Sciences Authority, provisional authorization; Philippines Food and Drug AdministrationPCR
Kogene Biotech2019 Novel Coronavirus Real-time PCR Kit CE 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
LabGenomics

LabGun COVID-19 RT-PCR Kit

EUA 4/29/2020  PCR
Laboratory Corporation of AmericaLabCorp 2019 Novel Coronavirus testEUA 3/16/2020  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
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

Maccura Biotechnology

SARS-CoV-2 Fluorescent PCR Kit

EUA 4/15/2020  PCR

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
Mesa BiotechAccula SARS-CoV-2 testEUA 3/23/2020  PCR

MicroGenDx (Southwest Regional PCR Laboratory)

COVID-19 Key

EUA 3/23/2020  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

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

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020CE mark 5/2020 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
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

One Health Laboratories

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

EUA 5/13/2020   PCR

Opti Medical Systems

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

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020CE mark 3/2020 PCR
PlexBio

IntelliPlex SARS-CoV-2 Detection Kit

 CE mark 5/2020 PCR
QiagenQiaStat-Dx Respiratory SARS-CoV-2 PanelEUA 3/30/2020CE mark 3/2020 PCR
Quest DiagnosticsCoronavirus Disease 2019 (COVID-19) TestEUA 3/17/2020  PCR
QuidelSofia 2 SARS Antigen FIAEUA 5/8/2020  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

MosaiQ COVID-19 Antibody Microarray

 CE mark 5/2020 Serological

Rendu Biotechnology

2019-nCoV detection kit

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

Elecsys Anti-SARS-CoV-2

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

Rutgers University Clinical Genomics Laboratory

ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit

 
EUA 4/10/2020, amended 5/7/2020  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

EUA submission pending  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

Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical

 

novel coronavirus nucleic acid detection kit

 CE mark 3/2020China NMPA 3/2020PCR

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

ADVIA Centaur SARS-CoV-2 Total (COV2T)

 
EUA 5/29/2020CE mark 5/2020 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
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

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
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
Tataa Biocenter

TATAA GrandPerformance SARS-CoV-2 detection kit

 CE mark 3/2020 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
Trax Management ServicesPhoenix Dx 2019-CoVEUA 4/20/2020  PCR

Ultimate Dx Laboratory

UDX SARS-CoV-2 Molecular Assay

EUA 4/20/2020  PCR

University of North Carolina Medical Center

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

 
EUA 4/10/2020   PCR

UTMG Pathology Laboratory

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

EUA 5/1/2020   PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test

 CE mark 4/2020

Singapore Health Sciences Authority provisional authorization

PCR

Viracor Eurofins

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

Xiamen Wiz Biotech

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

 CE mark 3/2020 Serological

Yale New Haven Hospital Clinical Virology Laboratory

SARS-CoV-2 PCR test

EUA 3/31/2020  PCR

YD Diagnostics

MolecuTech Real-Time COVID-19

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

Zhejiang Orient Gene Biotech

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

Zymo Research

Quick SARS-CoV-2rRT-PCR Kit

EUA 5/7/2020   PCR

CDC Director Robert Redfield told a congressional subcommittee about the test, for which the center plans to seek Emergency Use Authorization from the FDA.

The company said it is recruiting 200 staff members in science, engineering, and manufacturing to support its role within a national SARS-CoV-2 testing program.

The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.

The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.

The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.

The first year's pilot phase aimed to develop an infectious disease digital health and precision medicine platform connecting healthcare facilities to NYSDOH.

he firm will use the proceeds to expand manufacturing capacity for its existing and in-development COVID-19 assays.

The firm this week received the CE-IVD mark for its point-of-care infectious disease test and is in the middle of a US clinical study to support an FDA submission.

Some parts of Europe turned to serology testing early to try to get a handle on the pandemic but had to quickly pull back after those tests performed abysmally.

The companies will use Coca-Cola bottle preforms— small plastic tubes that are heated and blown into a bottle shape for beverages — as test tubes.

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