FDA-Approved COVID-19 Tests

Test Kits

  1. CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel by Centers for Disease Control and Prevention (CDC) (Molecular) on 2/4/20
     
  2. New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel by Wadsworth Center, New York State Department of Public Health (Molecular) on 2/29/20
     
  3. cobas SARS-CoV-2 by Roche Molecular Systems, Inc. (Molecular) on 3/12/20
     
  4. TaqPath COVID-19 Combo Kit by Thermo Fisher Scientific, Inc. (Molecular) on 3/13/20
     
  5. COVID-19 RT-PCR Test by Laboratory Corporation of America (Molecular) on 3/16/20
     
  6. Panther Fusion SARS-CoV-2 Assay by Hologic, Inc. (Molecular) on 3/16/20
     
  7. Quest SARS-CoV-2 rRT-PCR by Quest Diagnostics Infectious Disease, Inc. (Molecular) on 3/17/20
     
  8. Lyra SARS-CoV-2 Assay by Quidel Corporation (Molecular) on 3/17/20
     
  9. Abbott RealTime SARS-CoV-2 assay by Abbott Molecular (Molecular) on 3/18/20
     
  10. ePlex SARS-CoV-2 Test by GenMark Diagnostics, Inc. (Molecular) on 3/19/20
     
  11. Simplexa COVID-19 Direct assay by DiaSorin Molecular LLC (Molecular) on 3/19/20
     
  12. Xpert Xpress SARS-CoV-2 test by Cepheid (Molecular) on 3/20/20 (CLIA waived)
     
  13. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay by Primerdesign Ltd. (Molecular) on 3/20/20
     
  14. Accula SARS-Cov-2 Test by Mesa Biotech Inc. (Molecular) 3/23/20 (CLIA waived)
     
  15. BioFire COVID-19 Test by BioFire Defense, LLC (Molecular) on 3/23/20
     
  16. PerkinElmer New Coronavirus Nucleic Acid Detection Kit by PerkinElmer, Inc. (Molecular) on 3/24/20
     
  17. AvellinoCoV2 test by Avellino Lab USA, Inc. (Molecular) on 3/25/20
     
  18. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 by BGI Genomics Co. Ltd (Molecular) on 3/26/20
     
  19. NxTAG CoV Extended Panel Assay by Luminex Molecular Diagnostics, Inc. (Molecular) on 3/27/20
     
  20. ID NOW COVID-19 by Abbott Diagnostics Scarborough, Inc. (Molecular) on 3/27/20 (CLIA waived)
     
  21. QIAstat-Dx Respiratory SARS-CoV-2 Panel by QIAGEN GmbH (Molecular) on 3/30/20
     
  22. NeuMoDx SARS-CoV-2 Assay by NeuMoDx Molecular, Inc. (Molecular) on 3/30/20
     
  23. COV-19 IDx assay by Ipsum Diagnostics, LLC (Molecular) on 4/1/20
     
  24. qSARS-CoV-2 IgG/IgM Rapid Test by Cellex Inc. (Serology IgM and IgG) on 4/1/20
     
  25. BioGX SARS-CoV-2 Reagents for BD MAX System by Becton, Dickinson & Company (Molecular) on 4/2/20
     
  26. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit by Co-Diagnostics, Inc. (Molecular) on 4/3/20
     
  27. ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit by ScienCell Research Laboratories (Molecular) on 4/3/20
     
  28. ARIES SARS-CoV-2 Assay by Luminex Corporation (Molecular) on 4/3/20
     
  29. Gnomegen COVID-19 RT-Digital PCR Detection Kit by Gnomegen LLC (Molecular) on 4/6/20
     
  30. Smart Detect SARS-CoV-2 rRT-PCR Kit by InBios International, Inc (Molecular) on 4/7/20
     
  31. QuantiVirus SARS-CoV-2 Test kit by DiaCarta, IncMolecular4/8/20
     
  32. BD SARS-CoV-2Reagents for BD MAX System by Becton, Dickinson & Company (Molecular) on 4/8/20
     
  33. iAMP COVID-19 Detection Kit by Atila BioSystems, Inc. (Molecular) on 4/10/20
     
  34. DPP COVID-19 IgM/IgG System by Chembio Diagnostic System, Inc (Serology IgM and IgG) on 4/14/20
     
  35. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack by Ortho Clinical Diagnostics, Inc. (Serology Total Antibody) on 4/14/20
     
  36. SARS-CoV-2 Fluorescent PCR Kit by Maccura Biotechnology (USA) LLC (Molecular) on 4/15/20
     
  37. COVID-19 ELISA IgG Antibody Test by Mount Sinai Laboratory (Serology IgG) on 4/15/20
     
  38. Curative-Korva SARS-Cov-2 Assay by KorvaLabs Inc. (Molecular) on 4/16/20
     
  39. GS™ COVID-19 RT-PCR KIT by GenoSensor, LLC (Molecular) on 4/16/20
     
  40. Fosun COVID-19 RT-PCR Detection Kit by Fosun Pharma USA Inc. (Molecular) on 4/17/20
     
  41. GeneFinder COVID-19 Plus RealAmp Kit by OSANG Healthcare (Molecular) on 4/18/20
     
  42. PhoenixDx 2019-CoV by Trax Management Services Inc. (Molecular) on 4/20/20
     
  43. Allplex 2019-nCoV Assay by Seegene, Inc. (Molecular) on 4/21/20
     
  44. RealStar SARS-CoV02 RT-PCR Kits U.S. by altona Diagnostics GmbH (Molecular) on 4/22/20
     
  45. STANDARD M nCoV Real-Time Detection Kit by SD Biosensor, Inc. (Molecular) on 4/23/20
     
  46. LIAISON SARS-CoV-2 S1/S2 IgG by DiaSorin Inc. (Serology IgG only) on 4/24/20
     
  47. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack by Ortho-Clinical Diagnostics, Inc. (Serology IgG only) on 4/24/20
     
  48. Anti-SARS-CoV-2 Rapid Test by Autobio Diagnostics Co. Ltd. (Serology IgM and IgG) on 4/24/20
     
  49. SARS-CoV-2 IgG assay by Abbott Laboratories Inc. (Serology IgG only) on 4/26/20
     
  50. U-TOP COVID-19 Detection Kit by SEASUN BIOMATERIALS (Molecular) on 4/27/20
     
  51. LabGun COVID-19 RT-PCR Kit by LabGenomics Co., Ltd. (Molecular) on 4/29/20
     
  52. Rheonix COVID-19 MDx Assay by Rheonix, Inc.(Molecular) on 4/29/20
     
  53. Platelia SARS-CoV-2 Total Ab assay by Bio-Rad Laboratories, Inc (Serology Total Antibody) on 4/29/20
     
  54. New York SARS-CoV Microsphere Immunoassay for Antibody Detection by Wadsworth Center, New York State Department of Health (Serology Total Antibody) on 4/30/20
     
  55. Bio-Rad SARS-CoV-2 ddPCR Test by Bio-Rad Laboratories, Inc (Molecular) on 5/1/20
     
  56. BioFire Respiratory Panel 2.1 (RP2.1) by BioFire Diagnostics, LLC (Molecular) on 5/1/20
     
  57. Elecsys Anti-SARS-CoV-2 by Roche Diagnostics (Serology Antibody) on 5/2/20
     
  58. Anti-SARS-CoV-2 ELISA (IgG) by EUROIMMUN US Inc. (Serology IgG) on 5/4/20
     
  59. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) by Sansure BioTech Inc. (Molecular) on 5/4/20
     
  60. FTD SARS-CoV-2 by Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) (Molecular) on 5/5/20

 

Laboratory Developed Tests

  1. SARS-CoV-2 PCR test by Yale New Haven Hospital, Clinical Virology Laboratory on 3/31/20
     
  2. SARS-Cov-2 Assay by Diagnostic Molecular Laboratory – Northwestern Medicine on 4/2/20
     
  3. SARS-CoV-2 RT-PCR test by Infectious Disease Diagnostics Laboratory – Children’s Hospital of Philadelphia on 4/2/20
     
  4. MGH COVID-19 qPCR assay by Massachusetts General Hospital on 4/3/20
     
  5. Viracor SARS-CoV-2 assay by Viracor Eurofins Clinical Diagnostics on 4/6/20
     
  6. Stanford SARS-CoV-2 assay by Stanford Health Care Clinical Virology Laboratory on 4/8/20
     
  7. Orig3n 2019 Novel Coronavirus (COVID-19) Test by Orig3n, Inc. on 4/10/20
     
  8. ThermoFisher – Applied Biosystems TaqPath COVID-19 Combo Kit by Rutgers Clinical Genomics Laboratory-Rutgers University on 4/10/20
     
  9. SDI SARS-CoV-2 Assay by Specialty Diagnostic (SDI) Laboratories on 4/10/20
     
  10. UNC Health SARS-CoV-2 real-time RT-PCR test by University of North Carolina Medical Center on 4/10/20
     
  11. SARS-CoV-2 Assay by Integrity Laboratories on 4/13/20
     
  12. COVID-19 RT-PCR Test by Pathology/Laboratory Medicine Lab of Baptist Hospital Miami on 4/13/20
     
  13. Childrens-Altona-SARS-CoV-2 Assay by Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital on 4/14/20
     
  14. SARS-CoV-2 Test by Exact Sciences Laboratories on 4/14/20
     
  15. CDI Enhanced COVID-19 Test by Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory on 4/15/20
     
  16. CirrusDx SARS-CoV-2 Assay by CirrusDx Laboratories on 4/15/20
     
  17. SARS-CoV-2 Molecular Detection Assay by Mayo Clinic Laboratories, Rochester, MN on 4/20/20
     
  18. SARS-CoV-2 PCR Test by Diatherix Eurofins Laboratory on 4/22/20
     
  19. COVID-19 Key by Southwest Regional PCR Laboratory LLC. dba MicroGen DX on 4/23/20
     
  20. UDX SARS-CoV-2 Molecular Assay by Ultimate Dx Laboratory on 4/24/20
     
  21. SARS-CoV-2 Assay by AIT Laboratories on 4/24/20
     
  22. SARS-CoV-2 Assay by Nationwide Children’s Hospital on 4/27/20
     
  23. SARS-CoV-2 Test by Biocerna on 4/28/20
     
  24. Altru Dx SARS-CoV-2 RT-PCR assay by Altru Diagnostics, Inc. on 4/30/20
     
  25. UTHSC/UCH SARS-CoV-2-RT-PCR Assay by UTMG Pathology Laboratory on 5/3/20