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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 May 21):

  • 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
  • altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S.
  • Applied DNA Sciences Linea COVID-19 Assay Kit
  • Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
  • Atila BioSystems iAMP COVID-19 Detection Kit
  • Autobio Diagnostics Co. Anti-SARS-CoV-2 Rapid Test
  • Avellino Lab USA AvellinoCoV2 Test
  • Becton, Dickinson & Company BD SARS-CoV-2Reagents for BD MAX System
  • Becton, Dickinson & Company BioGX SARS-CoV-2 Reagents for BD MAX System
  • BGI Genomics Co. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
  • BioFire Defense COVID-19 Test
  • BioFire Diagnostics BioFire Respiratory Panel 2.1
  • Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab Assay
  • Bio-Rad Laboratories SARS-CoV-2 ddPCR Test
  • BioMérieux SA SARS-COV-2 R-GENE
  • CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel 
  • Cellex qSARS-CoV-2 IgG/IgM Rapid Test
  • Cepheid Xpert Xpress SARS-CoV-2 Test
  • Chembio Diagnostic System DPP COVID-19 IgM/IgG System
  • Co-Diagnostics Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
  • DiaCarta QuantiVirus SARS-CoV-2 Test Kit
  • DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG
  • DiaSorin Molecular Simplexa COVID-19 Direct
  • 1drop Inc. 1copy COVID-19 qPCR Multi Kit
  • EUROIMMUN US Anti-SARS-CoV-2 ELISA (IgG)
  • 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
  • GeneMatrix NeoPlex COVID-19 Detection Kit
  • 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
  • Hologic Aptima SARS-CoV-2 Assay
  • Hologic Panther Fusion® SARS-CoV-2 Test
  • InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit
  • Ipsum Diagnostics COV-19 IDx Assay
  • KorvaLabs Curative-Korva SARS-Cov-2 Assay
  • LabGenomics Co. LabGun COVID-19 RT-PCR Kit
  • Laboratory Corporation of America, COVID-19 RT-PCR Test
  • Luminex Corporation ARIES SARS-CoV-2 Assay
  • Luminex Molecular Diagnostics NxTAG CoV Extended Panel Assay  
  • Maccura Biotechnology SARS-CoV-2 Fluorescent PCR 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)
  • 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
  • PerkinElmer New Coronavirus Nucleic Acid Detection Kit
  • Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay
  • QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel
  • 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 Molecular Systems cobas® SARS-CoV-2
  • Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-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 U-TOP COVID-19 Detection Kit
  • Seegene Allplex 2019-nCoV Assay
  • Sherlock BioSciences Sherlock CRISPR SARS-CoV-2 Kit
  • Thermo Scientific TaqPath COVID-19 Combo Kit
  • Trax Management Service PhoenixDx 2019-CoV
  • 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 May 21):

  • AIT Laboratories SARS-CoV-2 Assay
  • Altru Diagnostics Altru Dx SARS-CoV-2 RT-PCR 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
  • Diagnostic Molecular Laboratory – Northwestern Medicine SARS-Cov-2 Assay
  • Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test
  • Exact Sciences Laboratories  SARS-CoV-2 Test  
  • 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
  • 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
  • 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.