The Food and Drug Administration has given emergency-use authorization to diagnostic health care manufacturer Quidel Corp. for its COVID-19 antigen test, the first of its kind, the Wall Street Journal reported Saturday.
The FDA said antigen tests are “a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19.”
In contrast, antibody tests look for traces of past exposure.
Quidel already has placed about 36,000 test-analyzer instruments around the United States in hospital labs, emergency departments and doctors’ offices, and is “ramping up manufacturing to go from 200,000 tests [in the week of May 11] to more than a million a week within several weeks,” Douglas Bryant, Quidel’s chief executive, told the Journal.
The FDA noted the most commonly used test for COVID-19 until now, known as a PCR test, magnifies virus particles to ease their detection. Though “incredibly accurate,” running the tests and analyzing the results “can take time, the agency told the Journal.
Quidel’s technology uses nasal swabs to produce samples that are run on the company’s Sofia analyzers, which can be read in minutes.
“We want to be able to test people quickly,” Bryant told the Journal. “We want people to be able to get a test at an urgent-care center or a retail clinic.”
He said his company’s data show that their test is about 85% “sensitive,” or able to identify the new coronavirus when it is present.
The United States currently 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.
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