FDA

F.D.A. Approves First Antigen Test for Detecting the Coronavirus

Unlike commonly available coronavirus tests that use polymerase chain reaction, or PCR, antigen diagnostics work by quickly detecting fragments of virus in a sample. The newly approved Quidel test will rely on specimens collected from nasal swabs, according to the F.D.A., and they can only be processed by the company’s lab instruments.

“Diagnostic testing is one of the pillars of our nation’s response to Covid-19, and the F.D.A. continues to take actions to help make these critical products available,” the agency said in a statement on Saturday. “One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes.” The F.D.A. said it expects to grant emergency clearance for other antigen tests in the near future.

A shortage of coronavirus tests in the United States has hampered efforts to contain the pandemic, and has limited the capabilities of states seeking to

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F.D.A. Paves Way for Home Testing of Coronavirus

In a move that could significantly expand the nation’s testing capacity, the Food and Drug Administration has posted new guidelines that could pave the way for millions of people to test themselves for the coronavirus at home.

The guidelines allow companies to develop and market testing kits with the tools to swab their noses and mail the specimens to any lab in the country.

Access to tests has been improving, but nationwide testing shortages continue to hamper the ability of health authorities to identify and isolate people who are infected.

The F.D.A. said it hoped the new guidelines, posted on its site on Wednesday

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F.D.A. Clears First Home Saliva Test for Coronavirus

The test kit was developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. Rutgers received F.D.A. permission last month to collect saliva samples from patients at test sites but can now sell the collection kits for individuals to use at home. They will cost about $100 each, Rutgers said, and must be ordered by a physician.

“A patient can open the kit, spit into the tube, put the cap back on and ship it back to our lab,” said Dr. Andrew Brooks, chief operating officer and director of technology development at RUCDR.

Dr. Brooks said the tests should be used only by people who have Covid-19 symptoms. His lab can process 20,000 tests each day, with a 48-hour turnaround, but he expects other labs to adopt it for their own use.

The spit tests are part of a rapid emergency

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F.D.A. Bans 65 N-95 Style Face Mask Manufacturers

The Food and Drug Administration on Thursday barred more than 65 manufacturers in China from exporting N95-style face masks to the United States, citing poor quality.

In doing so, the F.D.A. slashed the number of Chinese companies approved to sell the masks in the U.S. to 14 from 80.

N95 masks, which provide better protection against coronavirus particles than cloth or surgical masks, are coveted by health care providers and emergency medical workers. On April 3, drastic shortages of the N95 masks led the F.D.A. to allow imports of similar masks from China.

As

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