“The Food and Drug Administration has a protocol called emergency use authorization, or EUA, through which it clears tests from labs around the country for use in an outbreak. Getting more of these tests up and running would greatly increase the capacity of doctors and public-health officials to screen patients for the coronavirus.
Former FDA officials I spoke with said that during past outbreaks, EUAs could be granted in just a couple of days. But this time, the requirements for getting an EUA were so complicated that it would have taken weeks to receive one..clinical labs were not allowed to begin testing at all before they had received the EUA, even if they had already internally made sure their tests worked. Though these regulations are in place to ensure that faulty lab tests don’t get used on patients, several microbiologists told me they felt the precautions were excessive for a fast-moving outbreak of this scale.”
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““Labs and companies need samples of the virus itself in order to make their tests, but delays in getting access to samples further slowed down the test-development process. The coronavirus originated in China, and as several microbiologists told me, the Chinese government does not allow specimens to be shipped outside its borders.”
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“Even when working with nonauthoritarian countries, a combination of government processes, researcher reticence, complex shipping regulations, and patient-privacy concerns makes getting samples difficult for diagnostic companies like his.”
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““Even though some hospitals actually have the new, functional CDC tests, the extraction machines and reagents that are used to perform them are in short supply.”
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“For months, President Trump has made light of the coronavirus, telling attendees at a Black History Month reception, for instance, that perhaps the virus could miraculously disappear. He claimed on Twitter that the U.S. has done a “great job” handling the outbreak. Such a cavalier attitude seems unlikely to have motivated health officials to take things seriously.”
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“Containing a new infectious disease requires a lot of close collaboration between the president, the CDC, the FDA, and other parts of the Department of Health and Human Services, several Obama-era health officials told me. “One reason we were able to move quickly [during the Ebola outbreak] was that there was a great deal of coordination and issue spotting and troubleshooting that went on,” Hamburg, the former FDA commissioner, told me.”
https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-testing-us-so-delayed/607954/