Why Hasn’t the U.S. Done More Coronavirus Tests?

Coronavirus samples at a laboratory in Scotland. Photo: WPA Pool/Getty Images

As cases of COVID-19 continue to spike around the world, the CDC warned on Tuesday that Americans should prepare for the likelihood that the coronavirus will eventually spread here. Amid escalating outbreaks outside of China, it’s clear that there has been undetected transmission of the virus from countries with which the U.S. has not restricted travel. While there has not been a corresponding spike in cases within the U.S., many health experts are warning the coronavirus may already be here. That remains an unknown though — in no small part because the U.S. has done very little testing for the virus. And thanks to problems at the CDC, including the distribution of a faulty test kit for the coronavirus, it’s not clear when the country’s testing capacity will improve.

“We’re testing everybody that we need to test,” President Trump insisted on Wednesday during his first press conference on the coronavirus. He’s almost certainly wrong.

Also on Wednesday, the U.S. confirmed its first coronavirus case of unknown origin — providing the first evidence that the virus is spreading, undetected, inside the U.S. without any known, direct link to the original outbreak in mainland China. It may not be the first undetected outbreak, either. On Monday, the Washington Post reported that at one unnamed hospital in the U.S., clinicians were unable to test a patient who had developed coronavirus-like symptoms after returning from a trip to Singapore.

Across the country, some health-care facilities and public health laboratories have begun looking for alternative ways to test for the virus, including using imported tests or developing their own, but those efforts have faced regulatory delays. At the same time, the CDC guidelines on who should be tested for the coronavirus have not been expanded, even as the disease has spread around the globe.

Below is a look at what’s gone wrong and what may come next.

How many people in the U.S. have been tested for the coronavirus?

According to the CDC, 445 people have been tested for the virus as of February 25, resulting in 15 confirmed coronavirus infections, including two cases resulting from person-to-person spread, and one case of unknown origin. Those totals only include cases detected and laboratory-tested inside the U.S. — not from people the U.S. has flown back from abroad, like the American passengers on the quarantined Princess Diamond cruise ship in Japan.

There is no centralized count of how many people are being monitored or have been asked to self-quarantine by local and state health officials around the country.

How does U.S. testing compare with other countries?

Not well. While the U.S. has tested less than 500 cases, U.K. health officials have conducted more than 7,100 coronavirus tests as of Wednesday, confirming 13 positive cases, and U.K. authorities have announced aggressive plans to test thousands more, including drive-thru coronavirus testing. South Korea, which is battling the largest known outbreak outside of China, already has drive-thru testing in place and the country’s health officials have already conducted more than 30,000 coronavirus tests — mostly within the last week. And just one province in Canada, Ontario, has already conducted more tests (629) than in the entire U.S.

Why have there been so few tests?

There are combination of factors limiting U.S. testing capacity, including guidelines limiting the surveillance and detection of potential coronavirus cases; an inadequate supply of coronavirus tests, due in part to regulatory hurdles; and ongoing problems at the CDC as it tries to develop and distribute an accurate test to the labs that need it.

As of Tuesday, only a dozen or so state and local health departments can currently test for the virus, and positive results still have to be confirmed by the CDC in Atlanta, according to Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases. Meanwhile, Politico reported last week that only three out of 100 public health laboratories in the U.S. could test for COVID-19, according to a lab industry official. Whatever the total number is, it’s clear that coronavirus test kits have not been made widely available to the hospitals and public health labs across the country that need them — and there is still no word on when that will change.

In addition, CDC guidelines only recommend testing people who are both showing symptoms of a respiratory illness and have either recently been to China or close to someone infected with COVID-19. Many health experts have called on the CDC to expand the guidelines, particularly now that China is far from the only country where the coronavirus has been spreading. The guidelines definitely made sense when China was the source of all known cases of the virus, but they haven’t been updated since.

Earlier this month, the CDC announced a large expansion of U.S. surveillance and testing for the coronavirus using health-care facilities and laboratories that were already part of the national influenza surveillance network the CDC uses to collect data about the seasonal flu. Public health labs across the country already test a few thousand patient samples per week as part of the program, so they would be in a good position to begin screening samples to look for the coronavirus. The CDC’s plan was to start testing coronavirus samples in five cities: Chicago, San Francisco, Los Angeles, Seattle, and New York City, then start expanding the testing to more parts of the country.

The CDC, with the FDA’s approval, had rapidly developed a test kit for the coronavirus, but after shipping it to state laboratories, additional testing of the kit determined that it had a faulty component and had to be scrapped. The CDC has been actively developing a new test kit since then, but no one seems to know when it will be finished and distributed. Messonnier, the CDC official, said on Tuesday that she thought the agency was “close” to being done with the new test.

Meanwhile, Health and Human Services Secretary Alex Azar, who leads President Trump’s coronavirus task force, has denied that the CDC test malfunctioned. Azar and the CDC have vowed full transparency over the U.S. coronavirus response, but that has not been the case so far.

There also remain questions about how budget and staffing cuts at the CDC under the Trump administration have impacted the agency’s capabilities. And there’s good reason to worry that the Trump administration may not always act in line with the agency’s guidance — there has already been at least one instance when the White House overruled the CDC in deciding how to handle confirmed coronavirus cases. On Wednesday, Trump directly contradicted the CDC in his first press conference on the coronavirus, noting that he didn’t think U.S. outbreaks were inevitable a day after the CDC had warned they were.

When will the U.S. be able to ramp up its coronavirus testing capacity?

That is not yet clear.

What are state and local health officials doing in the meantime?

According the Washington Post, hospitals and public health laboratories around the country have been scrambling to come up with alternative ways to test for the coronavirus, including importing tests from abroad or developing their own. But these efforts face serious obstacles:

The nation’s public health laboratories, exasperated by the malfunctioning tests in the face of a global public health emergency, have taken the unusual step of appealing to the Food and Drug Administration for permission to develop and use their own tests. In Hawaii, authorities are so alarmed about the lack of testing ability that they requested permission from the CDC to use tests from Japan. A medical director at a hospital laboratory in Boston is developing an in-house test, but is frustrated that his laboratory won’t be able to use it without going through an onerous and time-consuming review process, even if demand surges.

Former FDA commissioner Scott Gottlieb and former NSC biodefense director Luciana Borio recently argued in the Wall Street Journal that the U.S. needs to make it easier for state, local, and private forces to join the fight:

[U.S. authorities should] expand the types of diagnostic tests that can detect the virus. Right now the only test in use is one developed by the CDC. It is only conducted at CDC and at some public-health labs, which limits how many patients can be screened. The novel coronavirus has been declared a public-health emergency, which means that other tests from commercial and academic labs can’t be used without Food and Drug Administration approval.

The FDA could permit more labs to develop their own tests and also use manufactured diagnostic test kits that the labs can run on their existing platforms. The FDA can work closely with manufacturers of these kits, including large commercial labs, to make these tests more available under the agency’s emergency authority.

It’s also important to note that the CDC isn’t the only organization to have trouble developing an accurate test, and even the tests that work have to be conducted properly and at the right time, since there is evidence that some people infected with COVID-19 have tested positive after testing negative, because of the virus’s incubation period.

At the same time, state and local health jurisdictions have already been straining to handle even pre-outbreak workloads around the country. And coronavirus test kits aren’t the only critical resource in short supply.

Is there any evidence of undetected outbreaks in the U.S.?

Yes. On Wednesday night, the U.S. confirmed the first coronavirus case of unknown origin in Northern California — meaning health officials have found no link between the case and travel to China or exposure to another person who was infected with COVID-19. It is the first evidence that undetected community transmission of the coronavirus has been taking place in the America.

It is important to highlight, however, that as experts have pointed out, there does not seem to be any significant increase in the number of hospital patients with serious, unexplained lung infections. That’s the good news — for now. But as the CDC itself warned on Tuesday, it’s just a matter of time until new coronavirus outbreaks strike inside the country. Without adequate testing capacity, those outbreaks will be much more difficult to detect and contain.

This post has been updated to include President Trump’s comment on the testing and the news of the first confirmed coronavirus case of unknown origin in the U.S.

Why Hasn’t the U.S. Done More Coronavirus Tests?