RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 5 > FDA authorizes first antigen test for COVID-19, updates EUA templates

FDA authorizes first antigen test for COVID-19, updates EUA templates

Posted 11 May 2020 | By Michael Mezher 

FDA authorizes first antigen test for COVID-19, updates EUA templates

After issuing an emergency use authorization (EUA) for the first antigen test for coronavirus disease (COVID-19) over the weekend, the US Food and Drug Administration (FDA) on Monday updated its EUA templates for molecular diagnostics and posted a new EUA template for antigen test developers.
On Saturday, FDA announced it had issued an EUA to Quidel Corporation for its Sofia 2 SARS Antigen FIA test to detect SARS-CoV-2 antigens from nasopharyngeal and nasal swab specimens. FDA has previously issued dozens of EUAs to test makers and laboratories for polymerase chain reaction (PCR) and serological tests.
“Each category of diagnostic test has its own unique role in the fight against this virus. PCR tests can be incredible accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes,” said FDA Commissioner Stephen Hahn, who cautioned that while antigen tests are highly accurate in terms of detecting positive results, they have a higher chance of delivering false negatives.
As such, Hahn said that negative results should be confirmed with a PRC test to be more certain of the result.
The EUA allows for the use of Quidel’s antigen test at Clinical Laboratory Improvement Amendments (CLIA) certified high- and moderate-complexity laboratories and for point-of-care testing at facilities with a CLIA waiver.
FDA has also revised its immediately effective guidance on COVID-19 diagnostics to explain that it has moved its EUA templates that had previously been included within the guidance to its website for download.
In addition to revising its two EUA templates for molecular diagnostics, FDA created a new EUA template for antigen test developers to use to assist them in putting together an EUA submission.
FDA reiterates that test developers may use alternative approaches to those laid out in the templates and guidance but encourages them to seek feedback from the agency beforehand.
EUA, Statement

Regulatory Focus newsletters

All the biggest regulatory news and happenings.