In Vitro Diagnostic COVID-19 Tests

In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to coronavirus diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health. The companies listed below have developed IVDs that have received Emergency Use Authorization from the U.S. Food and Drug Administration.

To learn more about these tests and their availability, please visit the links below to access each company’s COVID-19 test information portal.

Antigen Tests

Tests to confirm an active infection by detect viral proteins ("antigens") shed in a patient sample.

• Quidel: Sofia 2 SARS Antigen FIA

Molecular Diagnostic Tests

Tests to confirm an active infection by detecting the virus' genetic material (RNA) in a patient sample.

• 1drop: 1copy COVID-19 qPCR Multi Kit
• Abbott: Abbott RealTime Sars-CoV-2 assay; ID NOW COVID-19; 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
• Atlia BioSystems: iAMP COVID-19 Detection Kit
• Becton, Dickinson & Company (BD): BioGX SARS-CoV-2 Reagents for BD MAX System; BD SARS-CoV-2 Reagents for BD MAX System
• BGI Genomics Co.: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
• BioCore Co.: BioCore 2019-nCoV Real Time PCR Kit
  BioFire Defense: Bio Fire® COVID-19 Test
• BioFire Diagnostics: BioFire Respiratory Panel 2.1 (RP2.1)
• BioMérieux: SARS-COV-2 R-GENE
• Bio-Rad Laboratories: Bio-Rad SARS-CoV-2 ddPCR Test
• Cepheid: Xpert® Xpress Sars-CoV-2
• Co-Diagnostics, Inc: Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
• DiaCarta: QuantiVirus SARS-CoV-2 Test Kit
• DiaSorin Molecular: Simplexa™ COVID-19 Direct Kit
• dba SpectronRx: Hymon SARS-CoV-2 Test Kit
  Fast Track Diagnostics (Siemens Healthineers): FTD SARS-CoV-2
• Fosun Pharma USA: Fosun COVID-19 RT-PCR Detection Kit
• GeneMatrix: NeoPlex COVID-19 Detection Kit
• GenMark Diagnostics: ePlex® SARS-CoV-2 Test
• GenoSensor: GS ™ COVID-19 RT-PCR KIT
• Gnomegen: Gnomegen COVID-19 RT-Digital PCR Detection Kit; Gnomegen COVID-19-RT-qPCR Detection Kit
• Hologic: Panther Fusion® SARS-CoV-2 Test; Aptima SARS-CoV-2 assay
• InBios International: Smart Detect SARS-CoV-2 rRT-PCR Kit
• LabGenomics Co.: LabGun COVID-19 RT-PCR Kit
• Luminex Molecular Diagnostics: NxTAG CoV Extended Panel Assay; ARIES SARS-CoV-2 Assay
• Maccura Biotechnology (USA): SARS-Cov-2 Fluorescent PCR Kit
• Mesa Biotech: Accula™ SARS-Cov-2 Test
• NeuMoDx Molecular: NeuMoDx SARS-CoV-2 Assay
• OPTI Medical Systems: OPTI SARS-CoV-2 RT PCR Test
• OSANG Healthcare: GeneFinder COVID-19 Plus RealAmp Kit
• PerkinElmer: Coronavirus Nucleic Acid Detection Kit
• PrimerDesign: COVID-19 genesig Real-Time PCR assay
• QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel
• Quidel: Lyra SARS-CoV-2 Assay; Lyra Direct SARS-CoV-2 Assay
• Rhenonix: Rheonix COVID-19 MDx Assay
• Roche Diagnostics: Cobas SARS-CoV-2
• Sansure BioTech: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
• ScienCell Research Laboratories: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
• Seasun Biomaterials: U-TOP COVID-19 Detection Kit; AQ-TOP COVID-19 Rapid Detection Kit
• Seegene: Allplex 2019-nCoV Assay
• SD Biosensor: STANDARD M nCoV Real-Time Detection Kit
• Sherlock BioSciences: Sherlock CRISPR SARS-Cov-2 Kit
• SolGent Co.: DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
  Thermo Fisher Scientific: TaqPath COVID-19 Combo Kit
• Trax Management Services: PhoenixDx 2019-CoV
• Zymo Research Corporation: Quick SARS-CoV-2rRT-PCR Kit

Serology Tests

Blood-based tests that can be used to identify whether individuals have been exposed to COVID-19 by examining the presence of antibodies to the virus.  Serology testing will be a key component of a national strategy to safely get Americans back to work.

• Abbott: SARS-CoV-2 IgG assay
• Autobio Diagnostics Co.: Anti-SARS-CoV-2 Rapid Test
• Bio-Rad Laboratories: Platelia SARS-CoV-2 Total Ab Assay
• Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
• Chembio Diagnostic System: DPP COVID-19 IgM/IgG System
• DiaSorin: LIAISON SARS-CoV-2 S1/S2 IgG
• EUROIMMUN US: Anti-SARS-CoV-2 ELISA (IgG)
• Healgen Scientific: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  Ortho Clinical Diagnostics: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
• Roche: Elecsys Anti-SARS-CoV-2
  Siemens: ADVIA Centaur SARS-CoV-2 Total (COV2T); Atellica IM SARS-CoV-2 Total (COV2T)