FDA approves the first COVID-19 antigen test for emergency use

05/12/2020 03:00 | 15

FDA approves the first COVID-19 antigen test for emergency use

PCR testing is used to identify coronavirus infection through a nasal swab and antibody testing — available only in conjunction with PCR — helps to detect those who have already had Covid-19, the disease caused by the virus.

Quidel (NASDAQ:QDEL) lands emergency use authorization from the FDA for a new antigen test that could help rapidly screen people for COVID-19.

However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests.

The FDA said it expects to authorize similar antigen tests in the future.

Between the lines: Antigen tests create a greater chance of false negatives, CNBC reports, and a negative antigen result may need to be confirmed with additional testing.

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

The main advantage of the antigen test is that it can provide results in minutes.

A third type of tests, antibody tests, use blood to look for proteins that are markers of a previous Covid-19 infection. "The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient". The tests can only be carried out in CLIA approved high and complex laboratories.

Dr Deborah Birx, a member of the White House Covid-19 task force, said in April that a "breakthrough innovation" in antigen testing was needed to speed reopening of the USA economy.

The United States now is running tests at a rate under half of the optimal level needed to be sure the public is safe to go back to work and resume other activities, the Journal reported, citing public health experts.

Shares of QDEL have doubled over the last 90 days.


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