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.

• Abbott: Abbott RealTime Sars-CoV-2 assay; ID NOW COVID-19
• Becton, Dickinson & Company (BD): 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: Bio Fire® COVID-19 Test
• Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
• Cepheid: Xpert® Xpress Sars-CoV-2
• DiaSorin Molecular: Simplexa™ COVID-19 Direct Kit
• GenMark Diagnostics: ePlex® SARS-CoV-2 Test
• Hologic: Panther Fusion® SARS-CoV-2 Test
• Luminex Molecular Diagnostics: NxTAG CoV Extended Panel Assay
• Mesa Biotech: Accula™ SARS-Cov-2 Test
• NeuMoDx Molecular: NeuMoDx SARS-CoV-2 Assay
• 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
• Roche Diagnostics: Cobas SARS-CoV-2
• Thermo Fisher Scientific: TaqPath COVID-19 Combo Kit