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FDA authorizes for antigen-based coronavirus test


May 9 (UPI) — The U.S. Food and Drug Administration issued the first emergency use authorization for a new kind of coronavirus test this week.

According to an FDA statement, once manufacturers start making the tests, “they can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.”

The new tests can produce results more quickly than the polymerase chain reactions tests in current use, but are more likely to produce false negatives — though positive results are highly accurate.

They work by detecting protein fragments called antigens, which are found on or within the virus, in samples collected using nasal swabs.

The emergency use authorization was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA, and certified by the Clinical Laboratory Amendments.

The FDA also said it has authorized two other test types under the emergency authorization and expects to authorize more in the near future to help gauge the coronavirus pandemic.

Also late Friday, Politico reported that FDA Commissioner Stephen Hahn is self-isolating for 14 days after exposure to White House Spokesperson Katie Miller, who tested positive for COVID-19 this week.

Administration officials said Hahn is asymptomatic and tested negative for the virus Friday.


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