Other countries are testing patients for coronavirus by the tens of thousands. Why the U.S. is so far behind

March 3, 2020, 9:40 AM UTC

South Korean officials are setting up “drive-thru” coronavirus screening facilities. Manufacturers in China have the capacity to distribute more than 1.5 million tests a week. The countries, alongside Italy and the U.K., are testing tens of thousands of people for the coronavirus, in many cases processing thousands of samples a day.

In the U.S., meanwhile, inadequate coronavirus testing has become a full-blown scandal. As U.S. cases spike, the Department of Health and Human Services has launched an investigation into defective testing kits that delayed lab results by several days, and experts are worried that a slow federal response may have given the virus more time to spread.

The U.S.’s testing missteps are especially alarming since the coronavirus’s initial spread in Asia gave U.S. officials fair warning that the outbreak was heading their way.

“If we had the ability to test earlier, I’m sure we would have identified patients earlier,” Jeff Duchin, the health officer for public health in Seattle and King County, Wash., where the first coronavirus death in the U.S. was reported, told the New York Times.

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The coronavirus outbreak neared 91,000 confirmed cases worldwide on Tuesday, and over 3,000 people have died. The rising number of confirmed cases in the U.S., which reflects both the continued spread of the virus and the fact that more testing is occurring after delays, has raised questions about U.S. government handling of the outbreak.

The U.S. Centers for Disease Control and Prevention (CDC) had been keeping track of the number of people tested for the coronavirus; the count stood at 472 people as of late Monday. But the tally was scrubbed from the website on Tuesday. The webpage now only lists the number who have tested positive—102 as of Tuesday, up from 86 the day prior. The U.S. reported its first two coronavirus-related deaths over the weekend, and the death toll in the U.S. reached six as of Tuesday.

A faulty first test

The coronavirus’s emergence in Asia in December and January gave the U.S. weeks to prepare, but even in the early stages, diagnostic testing hit snags.

The CDC, a U.S. federal agency, opted to develop its own test kit rather than use the existing one recommended by the World Health Organization; it is not yet clear why. Early on, CDC sent 200 of its test kits to state labs across the country (each kit can test 700 to 800 samples), but in mid-February, the agency announced that some of the kits were flawed, and asked labs to send samples to the CDC’s central lab in Atlanta to be tested, a move that delayed results by several days.

Medical professionals take samples from drivers with suspected symptoms of the COVID-19 coronavirus at a “drive-thru” virus test facility north of Seoul, on February 29, 2020. South Korea is testing possible coronavirus patients by the thousands.

But until last week, only 12 labs had the capacity to test for the virus. As of Saturday night, 31 public health labs were able to carry out the test, Scott Becker, the chief executive officer of the Association of Public Health Laboratories (APHL), said on Twitter. Becker said more than 100 labs—out of APHL’s more than 200 members—would be ready to test for the virus next week, after the CDC sent out more test kits.

The CDC until recently also restricted who could be tested—ruling out people who did not show symptoms and who had not been in contact with a confirmed case or traveled to affected countries. The limits seemed to ignore a key trait of the new coronavirus; that asymptomatic sufferers may still be able to spread the virus.

Regulatory hurdles

Regulatory procedures have also slowed down the process. Commercial and state labs typically need Food and Drug Administration (FDA) approval before they can develop diagnostic tests.

On Feb. 29, the FDA announced a new policy to help expedite the process for labs applying for FDA approval, and signed off on the Wadsworth Center in New York as the first non-CDC lab approved to test for the virus. A Wadsworth lab test confirmed the first coronavirus case in New York state.

The U.S. now has new test kits for 75,000 people, and more are on the way, Health and Human Services Secretary Alex Azar said on CBS’s “Face the Nation” on Sunday. He promised a “radical expansion” of testing in the next week or two.

At least one medical professional is skeptical. “We hear that [the tests are] coming very soon, but I’m here to tell you right now, at one of the busiest hospitals in the country, I don’t have it at my fingertips, I still have to call the Department of Health, I still have to make my case, plead to test people, this is not good,” Matt McCarthy, a staff physician at New York-Presbyterian Hospital, told CNBC.

McCarthy added that there would be “thousands [of cases] by next week, and this is a testing issue.” McCarthy called the lack of coronavirus testing in the U.S. a “national scandal.”

“Although [the testing delay in the U.S.] will soon improve, production of these kits—should infection rate increase and COVID become pandemic—will need to be ramped up and deployed to all hospitals and clinics without delay,” said Alan Hsu, a post-doctoral research fellow at the University of Newcastle in Australia who studies influenza viruses.

But some experts worry that even when test kits become widely available in the U.S., many people will be deterred from getting tested for the virus for fear of expensive medical bills.

Federal funds cover the cost of the test in federal, state and local public health labs, but do not extend to academic or commercial labs, nor do they cover emergency room, doctor’s office, or urgent care visits.

New York Governor Andrew Cuomo on Monday evening issued a directive requiring New York health insurers to waive cost sharing associated with testing for the coronavirus and said New York residents with Medicaid coverage would not be charged co-pays for coronavirus testing.

How are other countries doing?

As the U.S. struggles, other nations have rolled out coronavirus testing on massive scales. South Korea, which has 4,812 confirmed cases and a population around six and a half times smaller than the U.S., had tested more than 121,000 people as of Tuesday, using a test developed in-country.

As coronavirus cases spiked in the country, President Moon Jae-in raised South Korea’s alert level to its highest, empowering the government to carry out sweeping measures to control the virus.

The government designated coronavirus-only hospitals, expedited the approval of newly-built wards, and required anyone visiting a hospital with respiratory symptoms to be tested—even allowing doctors to order a coronavirus test if the patient refuses one. The alert also made it easier for officials to access the personal data of suspected cases and allocate more funds to fight the virus.

South Koreans are queuing for Starbucks-inspired drive-thru coronavirus testing facilities, which local health officials are setting up in parking lots. Medical workers lean into the car window, check individuals inside for fever and other symptoms, and take a secretion sample for examination—all in less than 10 minutes.

Northern Italy In The Grip Of Covid-19 Coronavirus
Health care workers prep evaluation swabs for coronavirus in the research laboratory of a hospital in Turin, Italy. Other countries have tested for coronavirus at scale as the U.S. has struggled to test only dozens of patients.
Stefano Guidi—Getty Images

The drive-thru helps offset the wait times and crowds of hospitals and clinics, which lowers infection risks because fewer people will be in a room together for a shorter period of time. Drivers also do not need to get out of their cars for the drive-thru checks, which also lowers infection risk.

In the U.K., which has a population five times smaller than the U.S., 13,525 people had been tested for coronavirus by Monday—13,485 tested negative and 40 were confirmed positive. Italy, which has over 2,000 confirmed cases and a population size similar to the U.K., had carried out more than 23,000 tests as of Tuesday.

South Korea and Italy have the highest number of confirmed cases outside of China. Both Korea and Italy, as well as the U.K., have a national health service that provides residents with universal coverage.

Importance of coronavirus testing

Because the vast majority of COVID-19 cases can present as mild, with symptoms like fever and cough that are common in the flu and other respiratory viruses, health professionals are “highly dependent on the use of diagnostics” to identify COVID-19, said Meru Sheel, an epidemiologist at Australian National University.

The World Health Organization has manufactured coronavirus test kits and is making 250,000 kits available to 159 laboratories around the world to ensure that countries that cannot manufacture their own kits will be able to test for the virus; countries that don’t have the facilities to use the test kits can send samples back to WHO labs for diagnosis.

So far, 18 countries in Africa have confirmed they have the ability to test for the virus, and 31 countries in Europe have also established testing capabilities.

Countries that have to ship samples to other parts of the world will have to bear “significant delays in getting access to the results,” Sheel said. To minimize the risk of infection, health officials in these countries should treat individuals that show symptoms and have links to a confirmed case as if they are a confirmed case, until their results come back negative.

More must-read stories from Fortune:

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Coronavirus is giving China cover to expand its surveillance. What happens next?
—Coronavirus shows why we need vaccines before, not after, an outbreak
—Before coronavirus, there were SARS and MERS. Do epidemics ever really end?

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