Why Coronavirus Testing in the U.S. is so Slow

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While the United States succeeded where many failed in the early global fight against the novel coronavirus, which originally spread out of the Chinese city, Wuhan, in late December of 2019, one major failure faced by the U.S. is the national shortage of COVID-19 test kits; an issue almost unique to this country.

The United States was one of the first countries to put travel restrictions in place to limit the number of potentially infected people coming into the country, which, according to many experts, delayed the spread of disease. A little over a week after the first infection was confirmed in the U.S., flights coming out of Wuhan were blocked. While it bought the country some time, the virus nonetheless persisted and took root on U.S. soil.

Federal, state, and local governments in cooperation with the private sector essentially shut down most if not all forms of public gatherings, leading to the previously unheard of cancellation of every major sporting organization’s seasons, and other mass gatherings where infections can spread like wildfire. There’s also been a very successful national work from home initiative pushed by private companies.

However, all these measures can do is delay the inevitable. The disease will surely continue to spread, and unless health officials can identify carriers, quarantine and treatment efforts will fall flat.

But why has the US failed to implement mass testing of at risk people? The short answer is government. While countries like South Korea were able to test well over 200,000 people, the CDC has tested barely 5% of that number. Because South Korea was able to quickly identify everyone who was infected, they were able to isolate carriers before they spread the virus to others, and their new infections number reflects this.

According to The Atlantic, “the Food and Drug Administration has a protocol called emergency use authorization, or EUA, through which it clears tests from labs around the country” to test patients. Authorizing more labs to actually test for the coronavirus has been uniquely slow during this pandemic. Unlike previous outbreaks, “the requirements for getting an EUA [are] so complicated that it would have taken weeks to receive one, says Alex Greninger, the assistant director of the virology division at the University of Washington Medical Center.” Red tape and bureaucracy have been the biggest struggle to getting more facilities up and running.

Until a lab gets authorization they cannot begin testing, regardless of how effective internal testing is.

Greninger wrote a letter to Congress on February 28th, saying “many of our clinical laboratories have already validated [tests] that we could begin testing with tomorrow, but cannot due [to] the FDA EUA process.”

“The Chinese government does not allow specimens to be shipped outside its borders,” according to The Atlantic, so labs are having a hard time getting samples of COVID-19 to actually create test kits.

“The type of test Greninger is making is called a lab-developed test. To be used in other labs, his test requires special instruments that extract and then amplify the RNA that makes up the virus. However, labs across the country—like those at many county hospitals—don’t have the tools to do this. They can only run a simple type of test called a sample-to-answer test. As late as this week, several lab directors told me that no sample-to-answer versions of the coronavirus test had been approved in the U.S.”

Even the tests being approved and created require specialty instruments not widely used by most hospitals. The FDA has not approved any tests which would be easier for most healthcare providers to use.

Other issues include shortages in the chemicals used in the testing process. According to the LA Times, the chemicals needed, known as reagents, are used to extract genetic material from a nasal swab sample, among the first steps in the testing process. Demand for reagents has left a key supplier struggling to keep pace with orders from countries around the world.”

However, though there are massive delays in getting approvals, the FDA issued a new policy for “certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their Emergency Use Authorization (EUA) requests.” The government is working to lower the largest hurdle to testing… itself.

Scientific tool manufacturer Thermo Fisher said it plans on producing up to 5 million test kits for novel coronavirus in the next few weeks. Trump said in a statement Thermo Fisher could produce up to 1.4 million of those tests in the next week. They’re hoping to hit maximum production by April 3rd. Roche, another pharmaceutical company, says it can manufacture 400,000 tests a week. They were recently approved by the FDA to begin production.

Roche began production ahead of their approval, so tests will hopefully be sent out soon.

Unlike the U.S., “Korean officials enacted a key reform, allowing the government to give near-instantaneous approval to testing systems in an emergency” long before the current outbreak. “Within weeks of the current outbreak in Wuhan, China, four Korean companies had manufactured tests from a World Health Organization recipe and, as a result, the country quickly had a system that could assess 10,000 people a day,” Pro Publica reports.

South Korea’s rapid deployment of testing has given them one of the world’s lowest mortality rates for the novel coronavirus.

Though a vaccine could be only weeks away from trials, according to Dr. Fauci of the National Institute of Allergy and infectious Diseases, the spread of COVID-19 will get much worse as time goes on, and our only hope is to identify the infected, and maintain social distancing and personal hygiene in order to mitigate the spread of disease.



Categories: U.S. News

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