Commercially Available COVID-19 Diagnostic Tests
As labs are trying to meet the demand for assays to detect Coronavirus, Myndshft is keeping a list up to date daily with information on the regulatory status of these tests in the US. The tracker includes only those tests that are available for diagnostic use. Links to primary regulatory decisions are provided where available.
To See a List of Specimen Testing and Shipping Information click here.
| Company/Organization Name | Test Name | US Regulatory Status |
| Abbott | Abbott RealTime SARS-CoV-2 EUA test | EUA 3/18/2020 |
| ARUP Laboratories | COVID-19 | Lab test; EUA planned |
| Avellino Lab | Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | Lab test; EUA planned |
| BGI | Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2) | EUA planned |
| BioReference Laboratories | Novel Coronavirus COVID-19 | Lab test, EUA planned |
| Centers for Disease Control and Prevention (performed at qualified high-complexity CLIA laboratories designated by CDC) | CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) | EUA 2/4/2020, amended 3/15/2020 |
| Cleveland Clinic, University Hospitals | COVID-19 test | CDC test |
| Co-Diagnostics | Logix Smart Coronavirus COVID-19 | EUA submitted |
| Diagnostic Solutions Laboratory | COVID-19 Assay | Lab test, EUA submitted |
| DiaSorin Molecular | Simplexa COVID-19 Direct | EUA 3/19/2020 |
| Diatherix Eurofins | COVID-19 Panel | Lab test, initially not available in NY State |
| Fulgent Genetics/MedScan Laboratory | COVID-19 | Lab test, EUA planned |
| GenMark Diagnostics | ePlex SARS-CoV-2 Test | EUA 3/19/2020 |
| Hackensack Meridian Health CDI | SARS-COV-2 test | Lab test; preliminary EUA, New Jersey DOH approval |
| Hologic | Panther Fusion SARS-CoV-2 assay | EUA 3/16/2020 |
| Integrated DNA Technologies/Danaher | IDT 2019-novel coronavirus kit | Kit, under CDC EUA |
| Laboratory Corporation of America | LabCorp 2019 Novel Coronavirus test | Lab test, EUA 3/16/2020 |
| LGC, Bioresearch Technologies | 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | Kit, under CDC EUA |
| NorthShore University HealthSystem | Novel Coronavirus test | Lab test; EUA planned |
| Northwell Health | 2019 Novel Coronavirus PCR | Lab test; EUA planned |
| NY State Department of Health (performed at Wadsworth Center and New York City Department of Health and Mental Hygiene, Public Health Laboratories) | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Lab test, EUA 3/10/2020 |
| Quest Diagnostics | Coronavirus Disease 2019 (COVID-19) Test | Lab test, EUA 3/17/2020 |
| Quidel | Lyra SARS-CoV-2 Assay | EUA 3/17/2020 |
| Roche | Cobas SARS-CoV-2 Test | EUA 3/12/2020 |
| Stanford Clinical Virology Laboratory | SARS-CoV-2 RT-PCR test | Lab test; EUA planned |
| Thermo Fisher Scientific | TaqPath COVID-19 Combo Kit | EUA 3/13/2020 |
| University of North Carolina Medical Center McLendon Clinical Laboratories | COVID-19 PCR, on WHO protocol | Lab test, EUA planned |
| University of Washington Medicine Clinical Virology Lab | SARS-CoV-2 PCR test | Lab test; EUA planned |
| UPMC | COVID-19 test | Lab test |
| Viracor Eurofins | Coronavirus SARS-CoV-2 RT-PCR assay | Lab test, EUA planned |
| Zhejiang Orient Gene Biotech | COVID-19 IgG/IgM Rapid Test | EUA planned |
Last updated: March 20, 2020
Self Reported Labs Performing COVID-19 Diagnostic Tests
| Lab Name | Website | Location Availability |
| Ammon Labs | http://www.ammonlabs.com | Continental US except Nevada |
| Dynamic Medical, LLC | http://dynamicmedicalusa.com/ | Salem, VA |
| HealthTrackRx/AIT | www.healthtrackrx.com | Texas, Ohio, California, Florida, Georgia, Mississippi, Kentucky, North Carolina, Indiana, and West Virgina |
| Certus Laboratories, LLC | www.certuslaboratories.net | Mississippi, Alabama, Louisiana, Tennessee, Georgia, Texas, South Carolina, Florida |
| Genesis Diagnostics | genesisdx.com | Langhorne, Pennsylvania |
| Genesis Reference Labs | https://genesisreferencelabs.com | All States |
Last updated: March 20, 2020