FDA Approves First COVID-19 Antigen Test for Emergency Use

FDA Bans 65 Chinese Mask Makers for Failing to Meet Filtration Standards

The Food and Drug Administration (FDA) has revoked approval for more than 60 N95-type mask manufacturers in China to export to the United States, after testing found that many of their products did not meet quality standards. The agency on May 7 cut the number of authorized manufacturers in China to 14 from around 80. Previously, on April 3, it had authorized the import of China-made masks that hadn’t been tested to counter shortages in personal protective equipment. One condition of that policy, however, was that the masks be tested by independent labs. Millions of masks had been imported since then. Testing by the National Institute for Occupational Safety and Health (NIOSH) under the Centers for Disease Control and Prevention found that many of the masks did not meet the…

Federal authorities announced Saturday that emergency-use authorization has been granted for the first antigen test for COVID-19, the disease caused by the CCP virus.

The Food and Drug Administration (FDA), in a May 9 release, said the authorization was issued late Friday to Quidel Corporation for an antigen test, a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19.

Antigen tests detect the presence of the disease, while antibody tests indicate past infection.

FDA chief scientist Denise Hinton said in a letter (pdf) that Quidel’s test, called the Sofia 2 SARS Antigen FIA, that based on the scientific evidence, “it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks.”

Hinton added that the emergency-use approval for the new antigen test does not mean it has been cleared or approved by the FDA for widespread use, but only for use by authorized laboratories.

“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president, and chief executive officer of Quidel Corporation, in a release.

Bryant told The Wall Street Journal that Quidel has already placed around 36,000 test-analyzer instruments in medical facilities around the country, and that production would go from 200,000 tests in the week of May 11, “to more than a million a week within several weeks.”

Another type of active infection test the FDA has, in the past, issued emergency-use authorization for is the polymerase chain reaction (PCR) test, which is a diagnostic technique that detects the genetic material from the virus.

“Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, 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 FDA said in the release.

Former FDA Commissioner Scott Gottlieb, explaining in a CNBC op-ed how antigen tests work, wrote, “One approach is based on the use of antibodies that adhere to parts of the virus that contribute to its symptoms called antigens.”

“If virus is present, the antibodies bind to these viral antigens and produce a chemical reaction that signals the presence of an infection,” he added.

Based in San Diego, Quidel specializes in tests for flu, strep, and infectious diseases.

“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 company’s CEO stated.

Focus News: FDA Approves First COVID-19 Antigen Test for Emergency Use

China Needs to Develop More Nukes to Curb the US: Editor of Chinese State-Run Newspaper

China should expand its stock of nuclear warheads to 1,000 to counter the challenges posed by the United States, chief editor of the Chinese state-run Global Times newspaper argued in a May 8 social media post. The communist regime’s nuclear arsenal should include “at least 100 DF-41 strategic missiles,” said Hu Xijin, who is known for his hawkish stance on foreign relations. The DF-41, unveiled in mid-2019 by the rocket force of China’s military, the People’s Liberation Army (PLA), is estimated to have a 12,000- to 15,000-kilometer range, the longest nuclear operating range in the world, and is capable of striking the continental United States. “We love peace and promise not to use nuclear weapons first, but we need a bigger nuclear arsenal to suppress U.S. strategic ambition and impulse against…