FDA gives emergency authorization for new antigen test to help detect coronavirus quicker and cheaper
The U.S. Food and Drug Administration has issued the first emergency use authorization for a new category of tests, known as a covid-19 antigen test, to rapidly detect the ongoing pandemic.
These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
The main advantage of the antigen test is that it can provide results in minutes. However, it can’t detect all active infections, unlike polymerase chain reaction tests which are much more accurate but take longer to show results.
There is a higher chance of false negatives with an antigen test and a negative result may need to be confirmed with an additional PCR test prior to further treatments.
The emergency use authorization was issued on May 8 to Quidel Corporation for the Sofia 2 SARS Antigen FIA. The test was certified by the Clinical Laboratory Improvement Amendments.
Once manufacturers start producing these antigen tests, it can test millions of Americans per day. The antigen tests have a simpler design and can be produced at a lower cost than PCR tests.
The coronavirus has infected more than 3.9 million worldwide and killed at least 275,188, according to data compiled by Johns Hopkins University.
Widespread testing is important in assessing the problem and quickly identifying those who may need to be quarantined to reduce the risk of infecting others.
