Recent Developments in COVID-19 Diagnostic Testing

Bioeksen R&D Technologies

3Editor's Note: We will be regularly updating the list of EUA-approved tests contained in this article as more tests get FDA approval

One major challenge in the US response to the novel coronavirus pandemic has been the availability of test kits and the reagents required to use those kits. Public health authorities say accurate and widespread testing is critical in identifying COVID-19 hotspots and how it is spreading, as well as ensuring infected patients are treated quickly.

But, as recently as last week, the US had only 23 test kits per million people, according to Dr. Paul Biddinger, MD, FACEP, of Boston’s Massachusetts General Hospital (MGH), speaking in a webinar broadcast Mar. 13. “It’s hard to say we have a handle on the situation when we just can’t test,” said Biddinger, chief of MGH’s Division of Emergency Preparedness and director of the hospital’s Center for Disaster Medicine.

However, authorities are moving quickly to close that gap and ramp up testing capacity.

On Mar. 16, the US Food & Drug Administration (FDA) announced they are eliminating regulatory hurdles around the development and release of diagnostic tests for COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

The move by the FDA involves three main elements:

Allows states to take responsibility for diagnostic tests developed and used by labs in their states without having to go through the FDA
Expands the Feb. 29 guidance originally released for COVID-19 diagnostic testing to include commercially developed tests
Provides recommendations to manufacturers wanting to develop serological tests for COVID-19

Since the end of January, the FDA has being working with more than 100 diagnostic test developers. The regulator has helped more than 80 of those developers with tests they plan to bring through the FDA’s Emergency Use Authorization (EUA) process. As the COVID-19 situation is changing day by day, the FDA is asking that labs with questions about the EUA process, getting key supplies, or FDA policies call their toll-free line, 1-888-INFO-FDA.

At the moment, it’s not known how many test kits are now available as “this number fluctuates daily as more and more test developers get their tests in the field and start testing patients,” the FDA said in their Monday statement. “At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests.”

As of early Mar. 19, seven commercial developers and two non-commercial developers had received EUA authorization for certified clinical labs to use their tests. Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week. Roche plans to ship 400,000 of its cobas® SARS-CoV-2 tests for COVID-19 each week to labs authorized to run COVID-19 testing. Thermo Scientific also received authorization to distribute its real-time PCR (RT-PCR) diagnostic kits on Mar. 13 and plans to produce 5 million of those tests a week by April.

There are many more tests currently in development, including a new point-of-care test from California-based Fluxergy that may deliver results within 60 minutes and two tests from PathogenDx—one is a respiratory test that detects influenza A and B as well as COVID-19 and COVID mutations and the other focuses on air and surface environmental transmission, the company said in an email.

Limitations of key testing methods:

RT-PCR-based tests for COVID-19 seem to be the most common available from developers and while very sensitive, they do have some issues that could affect accuracy. Though manufacturers now have the go-ahead to develop serological tests, which measure the amount of proteins or antibodies responding to infection in a patient’s blood, it’s unclear how many developers will choose to do so. In their Mar. 16 statement, the FDA admitted these tests “are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis.”

COVID-19 diagnostic test kits currently available in the US that have been granted EUA (as of Sept. 14):

Abbott Diagnostics Scarborough BinaxNOW COVID-19 Ag Card
Abbott Diagnostics Scarborough ID NOW COVID-19
Abbott Laboratories SARS-CoV-2 IgG assay
Abbott Molecular Abbott RealTime SARS-CoV-2 Assay
Abbott Molecular Alinity m SARS-CoV-2 Assay
Access Bio CareStart COVID-19 MDx RT-PCR
Access Genetics OraRisk COVID-19 RT-PCR
Acupath Laboratories Acupath COVID-19 Real-Time (RT-PCR) Assay
Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S.
Applied BioCode SARS-CoV-2 Assay
Applied DNA Sciences Linea COVID-19 Assay Kit
Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
Assure Tech. Assure COVID-19 IgG/IgM Rapid Test Device
Atila BioSystems iAMP COVID-19 Detection Kit
Autobio Diagnostics Co. Anti-SARS-CoV-2 Rapid Test
Avellino Lab USA AvellinoCoV2 Test
3B Blackbio Biotech India (a subsidiary of Kilpest India) TRUPCR SARS-CoV-2 Kit
Babson Diagnostics aC19G1
BayCare Laboratories BayCare SARS-CoV-2 RT PCR Assay
Beckman Coulter Access SARS-CoV-2 IgG BD Veritor System for Rapid Detection of SARS-CoV-2
Becton, Dickinson & Company BD SARS-CoV-2Reagents for BD MAX System
Becton, Dickinson & Company BD Veritor System for Rapid Detection of SARS-CoV-2
Becton, Dickinson & Company BioGX SARS-CoV-2 Reagents for BD MAX System
Beijing Wantai Biological Pharmacy Enterprise Co. Wantai SARS-CoV-2 Ab Rapid Test
Beijing Wantai Biological Pharmacy Enterprise Co. Wantai SARS-CoV-2 RT-PCR Kit
BGI Genomics Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
BillionToOne qSanger-COVID-19 Assay
Biocan Diagnostics Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
BioCheck SARS-CoV-2 IgG and IgM Combo Test
BioCheck SARS-CoV-2 IgG Antibody Test Kit
BioCheck SARS-CoV-2 IgM Antibody Test Kit
BioCore Co. 2019-nCoV Real Time PCR Kit
Bioeksen R&D Technologies Bio-Speedy Direct RT-qPCR SARS-CoV-2
BioFire Defense COVID-19 Test
BioFire Diagnostics BioFire Respiratory Panel 2.1
Biohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
Biomeme SARS-CoV-2 Real-Time RT-PCR Test
BioMérieux SA SARS-COV-2 R-GENE
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab Assay
Bio-Rad Laboratories SARS-CoV-2 ddPCR Test
BioSewoom Real-Q 2019-nCoV Detection Kit
Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test
Boston Medical Center BMC-CReM COVID-19 Test
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
Cellex qSARS-CoV-2 IgG/IgM Rapid Test
CENTOGENE US CentoFast-SARS-CoV-2 RT-PCR Assay
Cepheid Xpert Xpress SARS-CoV-2 Test
Chembio Diagnostic System DPP COVID-19 IgM/IgG System
ChromaCode HDPCR SARS-CoV-2 Assay
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute Cleveland Clinic SARS-CoV-2 Assay
Clinical Reference Laboratory CRL Rapid Response
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
Co-Diagnostics Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
Color Genomics Color COVID-19 Test Self-Swab Collection Kit
Compass Laboratory Services SARS-CoV2 Assay
Cue Health Cue COVID-19 Test
Cuur Diagnostics SARS-CoV-2 Molecular Assay
dba SpectronRx Hymon SARS-CoV-2 Test Kit
Detectachem MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (Reissued October 2, 2020)
DiaCarta QuantiVirus SARS-CoV-2 Multiplex Test Kit
DiaCarta QuantiVirus SARS-CoV-2 Test Kit
Diagnostic Solutions Laboratory DSL COVID-19 Assay
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG
DiaSorin Molecular Simplexa COVID-19 Direct
Diazyme Laboratories DZ-Lite SARS-CoV-2 IgG CLIA Kit
Diazyme Laboratories DZ-Lite SARS-CoV-2 IgM CLIA Kit
1drop Inc. 1copy COVID-19 qPCR Multi Kit
DxTerity Diagnostics DxTerity SARS-CoV-2 RT-PCR Test
DxTerity Diagnostics DxTerity SARS-CoV-2 RT PCR CE Test
Eli Lilly and Company Lilly SARS-CoV-2 Assay
Emory Medical Laboratories SARS-CoV-2 RBD IgG Test
Enzo Life Sciences AMPIPROBE SARS-CoV-2 Test System
Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
Euroimmun US Anti-SARS-CoV-2 ELISA (IgG)
Euroimmun US EURORealTime SARS-CoV-2
Everlywell COVID-19 Test Home Collection Kit
Fast Track Diagnostics Luxembourg FTD SARS-CoV-2
Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
Fosun Pharma USA Fosun COVID-19 RT-PCR Detection Kit
Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test
Guardant Health Guardant-19
Gencurix GenePro SARS-CoV-2 Test
Gene By Gene SARS-CoV-2 Detection Test
GeneMatrix NeoPlex COVID-19 Detection Kit
Genetron Health (Beijing) Co. Genetron SARS-CoV-2 RNA Test
GenMark Diagnostics ePlex SARS-CoV-2 Test
GenoSensor GS™ COVID-19 RT-PCR Kit
George Washington University Public Health Laboratory GWU SARS-CoV-2 RT-PCR Test
Gnomegen COVID-19 RT-Digital PCR Detection Kit
Gnomegen COVID-19-RT-qPCR Detection Kit
Gravity Diagnostics COVID-19 Assay
Hangzhou Biotest Biotech Co. RightSign COVID-19 IgG/IgM Rapid Test Cassette
Hangzhou Laihe Biotech LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Healgen Scientific COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
Helix OpCo Helix COVID-19 NGS Test
Helix OpCo Helix COVID-19 Test
Hologic Aptima SARS-CoV-2 Assay
Hologic Panther Fusion® SARS-CoV-2 Test
Illumina COVIDSeq Test
InBios International SCoV-2 Detect IgG ELISA
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit
Inform Diagnostics SARS-CoV-2 RT-PCR Assay
Ipsum Diagnostics COV-19 IDx Assay
ISPM Labs, LLC dba Capstone Healthcare Genus SARS-CoV-2 Assay
Jiangsu Bioperfectus Technologies COVID-19 Coronavirus Real Time PCR Kit
Jiangsu CoWin Biotech Co Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test
KogeneBiotech Co. PowerChek 2019-nCoV Real-time PCR Kit
KorvaLabs Curative-Korva SARS-Cov-2 Assay
LabGenomics Co. LabGun COVID-19 RT-PCR Kit
Laboratorio Clinico Toledo SARS-CoV-2 Assay
Laboratory Corporation of America, COVID-19 RT-PCR Test
LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel
Luminex Corporation ARIES SARS-CoV-2 Assay
Luminex Corporation xMAP SARS-CoV-2 Multi-Antigen IgG Assay
Luminex Molecular Diagnostics NxTAG CoV Extended Panel Assay
LumiraDx UK LumiraDx SARS-CoV-2 Ag Test
LumiraDx UK LumiraDx SARS-CoV-2 RNA STAR
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit
Mammoth Bioscience SARS-CoV-2 DETECTR Reagent Kit
Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit
Mesa Biotech Accula SARS-Cov-2 Test
MiraDx SARS-CoV-2 RT-PCR Assay
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
NeuMoDx Molecular NeuMoDx SARS-CoV-2 Assay
New York SARS-CoV-2 Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)
Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR Test
Omnipathology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR
OPTI Medical Systems OPTI SARS-CoV-2 RT PCR Test
OPTOLANE Technologies Kaira 2019-nCoV Detection Kit
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit
P23 Labs TaqPath SARS-CoV-2 Assay
Patients Choice Laboratories PCL SARS-CoV-2 Real-Time RT-PCR Assay
PerkinElmer New Coronavirus Nucleic Acid Detection Kit
Phosphorus Diagnostics Phosphorus COVID-19 RT-qPCR Test
PlexBio Co. IntelliPlex SARS-CoV-2 Detection Kit
Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling Assay
PreciGenome FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay
PrivaPath Diagnostics LetsGetChecked Coronavirus (COVID-19) Test
Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test
Psomagen Psoma COVID-19 RT Test
QDx Pathology Services QDX SARS-CoV-2 Assay
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel
Quest Diagnostics Infectious Disease Quest Diagnostics HA SARS-CoV-2 Assay
Quest Diagnostics Infectious Disease Quest Diagnostics PF SARS-CoV-2 Assay
Quest Diagnostics Infectious Disease Quest Diagnostics RC SARS-CoV-2 Assay
Quest Diagnostics Infectious Disease Quest SARS-CoV-2 rRT-PCR
Quidel Corporation Lyra Direct SARS-CoV-2 Assay
Quidel Lyra SARS-CoV-2 Assay
Quidel Sofia 2 SARS Antigen FIA
Rheonix Rheonix COVID-19 MDx Assay
Roche Diagnostics Elecsys Anti-SARS-CoV-2
Roche Diagnostics Elecsys IL-6
Roche Molecular Systems cobas® SARS-CoV-2
Roche Molecular Systems cobas SARS-CoV-2 & Influenza A/B
Roche Molecular Systems cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Diagnovital SARS-CoV-2 Real-Time PCR Kit
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay
Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
Sansure BioTech Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
ScienCell Research Laboratories SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
SD Biosensor STANDARD M nCoV Real-Time Detection Kit
Seasun Biomaterials AQ-TOP COVID-19 Rapid Detection Kit
Seasun Biomaterials U-TOP COVID-19 Detection Kit
Seegene Allplex 2019-nCoV Assay
Shenzhen New Industries Biomedical Engineering Co. MAGLUMI 2019-nCoV IgM/IgG
Sherlock BioSciences Sherlock CRISPR SARS-CoV-2 Kit
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)
Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total Antibody Assay (CV2T)
Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total Antibody Assay (COV2T)
Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay
SolGent Co. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
Sugentech SGTi-flex COVID-19 IgG
T2 Biosystems T2SARS-CoV-2 Panel
TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit
TBG Biotechnology Corp. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit
Texas Department of State Health Services, Laboratory Services Section SARS-CoV-2 Assay
The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit
Thermo Scientific TaqPath COVID-19 Combo Kit
Tide Laboratories DTPM COVID-19 RT-PCR Test
TNS Co., Ltd COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit
Trax Management Services PhoenixDx 2019-CoV
Trax Management Services PhoenixDx SARS-CoV-2 Multiplex
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay
University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test
University of Arizona Genetics Core for Clinical Services COVID-19 ELISA pan-Ig Antibody Test
University of California San Diego Health UCSD RC SARS-CoV-2 Assay
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory MD Anderson High-Throughput SARS-CoV-2 RT-PCR Assay
Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test
Verily Life Sciences Verily COVID-19 RT-PCR Test
Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay
Wadsworth Center, New York State Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection
Wren Laboratories COVID-19 PCR Test
Xiamen Zeesan Biotech Co SARS-CoV-2 Test Kit (Real-time PCR)
Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect (reissued August 28, 2020)
ZhuHai Sinochips Bioscience Co. COVID-19 Nucleic Acid RT-PCR Test Kit
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit

In addition, the FDA has also granted EUA status for the following high complexity molecular-based laboratory developed tests for use in the labs in which they were developed (as of Aug. 14):

AIT Laboratories SARS-CoV-2 Assay
Altru Diagnostics Altru Dx SARS-CoV-2 RT-PCR Assay
Aspirus Reference Laboratory Aspirus SARS-CoV-2 rRT Assay
Avera Institute for Human Genetics SARS-CoV-2 Assay
Biocerna SARS-CoV-2 Test
Biocollections Worldwide SARS-Co-V-2 Assay
Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine, SARS-CoV-2-Assay
CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay
Color Genomics Color SARS CoV-2 Diagnostic Assay
Columbia University Laboratory of Personalized Genomic Medicine Triplex CII-CoV-1 rRT-PCR Test
Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay
CSI Laboratories CSI SARS-CoV-2 RT PCR Test
Diagnostic Molecular Laboratory – Northwestern Medicine SARS-Cov-2 Assay
Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test
Exact Sciences Laboratories Exact Sciences SARS-CoV-2 (N gene detection) Test
Exact Sciences Laboratories SARS-CoV-2 Test
Express Gene (dba Molecular Diagnostics Laboratory) 2019-nCoV RT-PCR Diagnostic Panel
Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test
Infectious Disease Diagnostics Laboratory - Children’s Hospital of Philadelphia SARS-CoV-2 RT-PCR Test
Infectious Diseases Diagnostics Laboratory (IDDL) - Boston Children’s Hospital Childrens-Altona-SARS-CoV-2 Assay
Integrity Laboratories SARS-CoV-2 Assay
Massachusetts General Hospital MGH COVID-19 qPCR Assay
Mayo Clinic Laboratories SARS-CoV-2 Molecular Detection Assay
Nationwide Children’s Hospital SARS-CoV-2 Assay
Nebraska Medicine Clinical Laboratory Vibrant COVID-19 Ab Assay
One Health Laboratories SARS-CoV-2 Real-Time RT-PCR-Test
Orig3n, Inc., Orig3n 2019 Novel Coronavirus (COVID-19) Test
Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19 RT-PCR Test
Rutgers Clinical Genomics Laboratory-Rutgers University ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit
Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key
Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 Assay
Stanford Health Care Clinical Virology Laboratory Stanford SARS-CoV-2 Assay
Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay
University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR Test
UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay
Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 Assay
Warrior Diagnostics SARS-CoV-2 Assay
Yale New Haven Hospital, Clinical Virology Laboratory SARS-CoV-2 PCR Test

Other companies are stepping up to provide quick access to lab automation products for COVID-19 diagnostic testing and products for COVID-19 research, including Hamilton Robotics, Microbiologics, and AMSBIO.

As the COVID-19 situation is evolving rapidly, be sure to reach out to the FDA or your local regulatory agency for the most up-to-date information on COVID-19 diagnostic tests.