(RxWiki News) The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a second COVID-19 antigen test.
This test is called the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2. It’s the second antigen test the FDA has approved.
The first antigen test was approved in early May. That approval was granted to Quidel Corporation for its Sofia 2 SARS Antigen FIA. This first approval for this test went through the FDA’s EUA.
Now, a second test has been approved — also through the FDA’s EUA. This new test helps in the rapid detection of the virus that causes COVID-19.
The BD (Becton Dickinson) Veritor System can help detect the virus with samples that are collected from the nasal cavity. The test can detect portions of proteins found on or within the virus that causes COVID-19.
This test can only be used by authorized laboratories that use the BD Veritor Plus Analyzer Instrument, the FDA noted.
“Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly,” said FDA Commissioner Dr. Stephen M. Hahn in a press release.
This antigen test differs from a polymerase chain reaction (PCR) test (a molecular diagnostic testing technique) because antigen tests provide much faster results. Furthermore, antigen tests don’t cost as much as PCR tests.
Antigen tests can provide results in minutes, helping to identify infection rates closer to real time so people can take the necessary steps to prevent the spread of the virus.
One important thing to note, however, is the fact that antigen tests may miss some active infections, according to the FDA.
Antigen tests are very specific for the virus. However, they are not as sensitive as molecular PCR tests.
This means a positive test is more accurate, but there is a chance for false negatives. A false negative means the test is negative for the virus when, in fact, the person has the virus.
As a result, a negative result may need to be confirmed with a PCR test.