Since the beginning of the SARS-CoV-2 pandemic, doctors, researchers, and government officials have coordinated methods of detecting the disease through testing. During the nearly two years since the pandemic began to seriously affect the nation, the U.S. Food and Drug Administration (FDA) has been examining and reexamining the methods used for Covid-19 testing under their Emergency Use Authorization (EUA) methods.
In late December and early January, the FDA released a series of updated EUA decisions regarding the various types of tests given to detect Covid-19. Some of these changes adjust the scope of the EUA usage of a device, while some devices are having their EUA status rescinded for various reasons. The FDA announced these changes in two batches: one addressing Molecular Diagnostic Tests, and the other addressing Antigen Diagnostic Tests.
Molecular diagnostic tests function broadly in two stages: collection and analysis. During the collection phase, a sample will be taken, commonly from the nose or throat, and sent to a laboratory for analysis. Once there, the sample will undergo a process called reverse transcriptase polymerase chain reaction (RT-PCR). A PCR test will extract any viral RNA in the sample, convert it into DNA, and multiply it. If the virus that is grown from the sample is Covid-19, then the sample is considered positive and the individual is informed of the diagnosis. Molecular diagnostic tests can be highly accurate as long as the sample is properly stored and collected.
The FDA updated the EUA clearance for 22 molecular diagnostic tests from December to January. Those molecular diagnostic tests were:
- PMLS SARS-CoV-2 Assay
- FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
- GWU SARS-CoV-2 RT-PCR Test
- Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
- PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1
- AQ-TOP COVID-19 Rapid Detection Kit
- PowerChek 2019-nCoV Real-time PCR Kit
- Cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- DTPM COVID-19 RT-PCR Test
- UCSD EXCITE COVID-19 Test
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test
- Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
- Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2
- BioCode CoV-2 Flu Plus Assay
- Quest Diagnostics Collection Kit for COVID-19
- Quest SARS-CoV-2 rRT-PCR
- Quest Diagnostics PF SARS-CoV-2 Assay
- Quest Diagnostics RC SARS-CoV-2 Assay
- Quest Diagnostics HA SARS-CoV-2 Assay
- Quest Diagnostics RC COVID-19+Flu RT-PCR
- PerkinElmer New Coronavirus Nucleic Acid Detection Kit
The FDA also updated the EUA clearance for a number of antigen diagnostic tests. Unlike molecular diagnostic tests, antigen tests detect Covid-19 by detecting specific proteins unique to Covid-19. In general, antigen tests are faster than PCR tests. This makes them preferable for individuals who are looking to know their results quickly.
From December to January, the FDA updated the EUA for 14 antigen diagnostic tests. Those tests were:
- BinaxNOW COVID-19 Ag Card
- BinaxNOW COVID-19 Ag 2 Card
- BinaxNOW COVID-19 Ag Card Home Test
- BinaxNOW COVID-19 Antigen Self Test
- BinaxNOW COVID-19 Ag Card 2 Home Test
- Biosensor Inc. COVID-19 At-Home Test
- CLINITEST Rapid COVID-19 Antigen Self-Test
- iHealth COVID-19 Antigen Rapid Test
- Simoa SARS-CoV-2 N Protein Antigen Test
- Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
- BD Veritor System for Rapid Detection of SARS-CoV-2
- Nano-Check COVID-19 Antigen Test
- CareStart COVID-19 Antigen test
- CareStart COVID-19 Antigen Home Test
As the nation continues to grapple with Covid-19, the FDA continues to update its EUA information. Some products, like the BioFire Respiratory Panel 2.1 (RP2.1), were removed from the EUA listing due to receiving De Novo clearance, formally authorizing the products through a traditional avenue.