Americans and other residents in the United States will no longer have to go to medical facilities to get themselves tested for the coronavirus as the first over-the-counter COVID-19 at-home diagnostic test received approval from the Food and Drug Administration (FDA) on Tuesday, December 15.
This announcement is another good news after shipments of Pfizer COVID-19 vaccines were received in various states starting Monday following FDA's approval for its emergency use last Friday, December 11.
According to FDA Commissioner Stephen Hahn, "Today's authorization is a major milestone in diagnostic testing for COVID-19," in a report by the New York Post.
The test, which is being manufactured by the diagnostics company Ellume, involves a nasal swab that can be done at home and produce near-instant results.
According to the FDA website, "the Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules."
The newly approved test could detect fragments of proteins of the SARS-CoV-2 virus taken from a nasal swab sample from any individual two years of age or older.
As stated on the FDA's website, "By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes," said Hahn.
While there are drawbacks to the first over-the-counter COVID-19 at-home diagnostic test, it is still a major development in diagnosing the infection, according to Jeff Shuren, the director for FDA's Center for Devices and Radiological Health.
The near-instant result is a big step, considering the FDA had given approval to more than 25 at-home consumer coronavirus tests. Still, results take longer because the collected samples had to be sent away to a lab.
The United States continues to lead other countries in having the highest number of COVID-19 infections worldwide, with more than 16 million cases and more than 300,000 deaths. In a day, it tallies more than 200,000 new cases.
However, the U.S. has already started administering Pfizer COVID-19 vaccines to its health workers on Monday as the vaccine continues to be shipped statewide.
In an earlier interview, Moncef Slaoui, the co-leader and chief advisor of the U.S. government's Operation Warp Speed coronavirus vaccine initiative, revealed their goal of vaccinating 100 million Americans by the end of February.
