FDA approves emergency authorization for new antigen COVID-19 tests

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This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses, said the FDA.

Former U.S. Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb in an interview on Face the Nation Sunday said the first antigen test to discover COVID-19 was a "game changer".

This method tests the antigens produced by the virus, prompting the body to begin producing antibodies.

Once manufacturers start producing these antigen tests, it can test millions of Americans per day. The FDA notes that test is less reliable at ruling out infection in patients and that negative results "may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative".

Similar to the rapid, swab-based tests used for different strains of the flu, antigen tests detect the unique fragments of proteins found on the outer walls of the novel coronavirus-as opposed to antibody tests, which gauge the body's immune response, or molecular tests, which search for specific genetic sequences linked to the virus.

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And because Quidel's evaluation indicated it has sensitivity of only 80% relative to PCR tests, "negative results do not rule out infection", the FDA cautioned in announcing the EUA.

US regulators have approved a new type of coronavirus test that administration officials have touted as a key to opening up the country.

The emergency use authorization was issued on May 8 to Quidel Corporation for the Sofia 2 SARS Antigen FIA. The tests can only be carried out in CLIA approved high and complex laboratories. The best advantage of an antigen test is early identification with testing.

The FDA said it expects more antigen tests to be authorised for Covid-19, and the agency said it would provide a template to guide future approvals.

Shares in Quidel have put on a dramatic rally recently, more than doubling year-to-date.

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