TABLE 1.
FDA-approved in vitro Emergency Use Authorization diagnostics available for SARS-CoV-2 as of 30 March 2020a
| Developer | Diagnostic platform |
|---|---|
| Centers for Disease Control and Prevention (CDC) | CDC 2019-nCoV real-time RT-PCR diagnostic panel |
| Wadsworth Center, New York State Department of Public Health (CDC) | New York SARS-CoV-2 real-time reverse transcriptase (RT)-PCR diagnostic panel |
| Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 |
| Thermo Fisher Scientific, Inc. | TaqPath COVID-19 combo kit |
| Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR test |
| Hologic, Inc. | Panther fusion SARS-CoV-2 |
| Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR |
| Quidel Corporation | Lyra SARS-CoV-2 assay |
| Abbott Molecular | Abbott RealTime SARS-CoV-2 assay |
| GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 test |
| DiaSorin Molecular, LLC | Simplexa COVID-19 direct assay |
| Cepheid | Xpert Xpress SARS-CoV-2 test |
| Primerdesign, Ltd. | COVID-19 Genesig real-time PCR assay |
| Mesa Biotech, Inc. | Accula SARS-Cov-2 test |
| BioFire Defense, LLC | BioFire COVID-19 test |
| PerkinElmer, Inc. | PerkinElmer new coronavirus nucleic acid detection kit |
| Avellino Lab USA, Inc. | AvellinoCoV2 test |
| BGI Genomics, Co. Ltd. | Real-time fluorescent RT-PCR kit for detecting SARS-2019-nCoV |
| Luminex Molecular Diagnostics, Inc. | NxTAG CoV extended panel assay |
| Abbott Diagnostics Scarborough, Inc. | ID Now COVID-19 |
| Qiagen GmbH | QIAstat-Dx respiratory SARS-CoV-2 panel |
| NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 assay |