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Recent Developments in COVID-19 Diagnostic Testing

Recent Developments in COVID-19 Diagnostic Testing

US boosts efforts to get test kits to labs that need them most, more tests get EUA approval

Rachel Muenz

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 July 27):

  • 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
  • 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
  • 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
  • BGI Genomics Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
  • BioCore Co. 2019-nCoV Real Time PCR Kit
  • BioFire Defense COVID-19 Test
  • BioFire Diagnostics BioFire Respiratory Panel 2.1
  • Biohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
  • 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
  • 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
  • Compass Laboratory Services SARS-CoV2 Assay
  • Cue Health Cue COVID-19 Test
  • dba SpectronRx Hymon SARS-CoV-2 Test Kit
  • 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
  • 1drop Inc. 1copy COVID-19 qPCR Multi Kit
  • Emory Medical Laboratories SARS-CoV-2 RBD IgG Test
  • Enzo Life Sciences AMPIPROBE SARS-CoV-2 Test System 
  • 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
  • Fosun Pharma USA Fosun COVID-19 RT-PCR Detection Kit
  • Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test
  • 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
  • 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 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
  • 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  
  • Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit
  • Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit
  • Mesa Biotech Accula SARS-Cov-2 Test
  • 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
  • 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
  • PerkinElmer New Coronavirus Nucleic Acid Detection Kit
  • Phosphorus Diagnostics Phosphorus COVID-19 RT-qPCR Test
  • PlexBio Co. IntelliPlex SARS-CoV-2 Detection Kit
  • 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
  • Psomagen Psoma COVID-19 RT Test
  • 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
  • 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
  • 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
  • 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)
  • SolGent Co. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
  • TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit
  • 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 Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory MD Anderson High-Throughput SARS-CoV-2 RT-PCR Assay
  • 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
  • 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 July 27):

  • 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.