The U.S. Food and Drug Administration announced Saturday that it was authorizing American laboratories to develop their own coronavirus tests, which should significantly increase the country’s testing capacity.
The effect could be rapid. About 80 labs and private companies have applied for emergency approval for tests they have already created. If they have submitted evidence that the tests work, the labs and companies will be able to use them immediately, rather than wait for the F.D.A. to complete reviews and issue approvals.
“This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation,” the F.D.A.’s commissioner, Stephen M. Hahn, said in a statement.
Experts have been frustrated with the limited availability of coronavirus tests in the U.S., which until now could only be provided by the Centers for Disease Control and Prevention. Broader testing will enable more rapid detection and isolation of people who have the coronavirus to help contain the spread of disease.
Why did this take so long?
What about antibody tests?
From the Jerusalem Post:
The US Centers for Disease Control and Prevention (CDC) may have harmed the country’s ability to track and detect the spread of the COVID-19 disease due to a series of missteps, including refusing to use the tests recommended by the World Health Organization (WHO), according to ProPublica.
As the virus began to spread, the CDC decided to start creating its own, more complicated test instead of using the test guidelines provided by the WHO. The test was made to check for a variety of different viruses. When the test was sent to labs across the country, it didn’t work and falsely flagged the presence of other viruses in harmless samples.
Update: From the WaPo of April 5, a detailed chronology of how our two public health agencies totally screwed up testing for Coronavirus in the US.