This week the FDA added to its list of authorized SARS-CoV-2 tests by issuing Emergency Use Authorizations (EUAs) for six molecular assays.
As of Aug 13, 2020, the FDA has now authorized 213 tests under EUAs, including 174 molecular tests, 37 antibody tests, and 2 antigen tests.
Aug 13
- ProLab Diagnostics, for its Pro-AmpRT SARS-CoV-2 Test
- Sample method: upper respiratory specimens, such as nasal, nasopharyngeal, and oropharyngeal swab specimens
- EUA available here
Aug 12
- LumiraDx UK Ltd, for its LumiraDx SARS-CoV-2 RNA STAR
- Sampling method: upper respiratory specimens, such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens, and bronchoalveolar lavage specimens
- EUA available here
- Biomeme Inc, for its Biomeme SARS-CoV-2 Real-Time RT-PCR Test
- Sampling method: nasopharyngeal, nasal, and oropharyngeal swab specimens, and nasopharyngeal wash/aspirate or nasal aspirate specimens
- EUA available here
Aug 11
- Solaris Diagnostics, for its molecular Solaris Multiplex SARS-CoV-2 Assay
- Sampling method: nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirates, nasal aspirates, bronchoalveolar lavage specimens
- EUA available here
- Alpha Genomix Laboratories, for its molecular Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
- Sampling method: nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swab specimens
- EUA available here
Aug 10
- George Washington University Public Health Laboratory, for its GWU SARS-CoV-2 RT-PCR Test.
- Sampling method: upper respiratory specimens (eg, nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs)
- EUA available here
The emergency use of the tests is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet requirements to perform high complexity tests, according to the agency.
