User:Shawndouglas/sandbox/sublevel1

As of September 2021, the U.S. Food and Drug Administration (FDA) has issued 260 EAUs for all types of molecular in vitro diagnostic test kits. Two hundred and eight of those 260 are only authorized to be used in CLIA-certified high-complexity laboratories, and 19 are rated for both moderate- and high-complexity. When looking at the makeup of the EUAs, a huge majority of those tests use some form of RT-PCR methods, with most using real-time or qualitative versions of RT-PCR (qRT-PCR). CLIA-waived RT-PCR tests are still rare, however. Eight PCR-based kits from five manufacturers have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices^[1]:

BioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ
Cepheid's Xpert Omni SARS-CoV-2
Cepheid's Xpert Xpress SARS-CoV-2
Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV
Mesa Biotech's Accula SARS-Cov-2 Test
Roche Molecular Systems' cobas SARS-CoV-2
Roche Molecular Systems' cobas SARS-CoV-2 & Influenza A/B
Visby Medical's COVID-19 Point of Care Test

Of course, there are many more test kits than those approved in the United States. The Foundation for Innovative New Diagnostics (FIND) is currently "collating an overview of all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19."^[2] As of September 2021, their site shows nearly 280 commercialized manual NAAT tests around the world (most being RT-PCR), with 30 in development. The AdVeritasDx test and controls database is also useful.^[3]