A series of missteps at the nation’s top public health agency caused a critical shortage of reliable laboratory tests for the coronavirus, hobbling the federal response as the pandemic spread across the nation.
President Donald Trump assured Americans early this month that the COVID-19 test developed by the Centers for Disease Control and Prevention is “perfect” and “anyone who wants a test can get a test.” But more than two months after the first U.S. case of the new disease was confirmed, many people still cannot get tested.
In the critical month of February, as the virus began taking root in the U.S. population, CDC data show government labs processed 352 COVID-19 tests — an average of only a dozen per day, an Associated Press review found.
“You cannot fight a fire blindfolded,” Tedros Adhanom Ghebreyesus, head of the World Health Organization, said at a recent briefing. “We cannot stop this pandemic if we don’t know who is infected.”
The Department of Health and Human Services, which includes the CDC, has begun an internal review to assess its own mistakes. But outside observers and federal health officials have pointed to four primary issues that together hampered the national response — the early decision not to use the test adopted by the World Health Organization, flaws with the more complex test developed by the CDC, government guidelines restricting who could be tested, and delays in engaging the private sector to ramp up testing capacity.
Combined with messaging from the White House minimizing the disease, that fueled a lackluster response that allowed the virus to spread, they said.
“There were many, many opportunities not to end up where we are,” Dr. Ashish K. Jha, the director of the Global Health Institute at Harvard, told the AP. “Basically, they took this as business as usual. … And that’s because the messaging from the White House was ‘this is not a big deal, this is no worse than the flu.’ So that message basically created no sense of urgency within the FDA or the CDC to fix it.”
Even as private labs have been cleared by government regulators to process tens of thousands of additional tests in the last two weeks, experts warn that the nation is still falling well short of enough testing capacity to keep ahead of the highly contagious virus.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said the CDC’s system wasn’t designed to test for and track a widespread outbreak, which he characterized as “a failing.”
Stephen Morrison, a health policy expert at the Center for Strategic and International Studies in Washington, called the testing issues a “debacle,” contributing to what he described as a confused and delayed federal response to the crisis.
On New Year’s Eve, Chinese scientists had informed the World Health Organization about a cluster of 27 pneumonia cases of unknown cause in the industrial megalopolis of Wuhan, which they linked to the city’s wholesale fish market. Less than two weeks later, the Chinese had sequenced the virus’ genetic makeup and shared it with the world.
Within days, German scientists had developed a test that could identify a unique part of the virus’ DNA. The WHO quickly adopted that test, publishing technical guidelines Jan. 17 and working with private companies to produce testing kits.
As they have done with some past outbreaks, officials at CDC headquarters in Atlanta decided to develop their own test, focusing on three gene targets distinct from what the WHO used. Over the decades, the headquarters lab had built a track record of being among the first to develop tests for new diseases and quickly making them available for tracking.
CDC published the technical details for its COVID-19 test on Jan. 28, 10 days after the WHO. By then, the virus had already been in the U.S. for at least two weeks.
The 35-year-old man who would become the first American to test positive had arrived in Seattle on Jan. 15, following a trip to Wuhan. After swabs from his nose and throat were flown to the CDC lab, federal officials announced the results Jan. 21.
In an interview the following day, Trump was asked about the risk to the nation.
“We have it totally under control,” he said. “It’s one person coming in from China. … It’s going to be just fine.”
On Jan. 30, the day WHO declared the outbreak a public health emergency, Trump again assured the American people that the virus was “very well under control.”
At that point, the CDC had confirmed just eight cases in the U.S.
Four days after the U.S. declared a state of emergency, only 178 patients had been tested and another 82 were listed as “pending,” meaning they were awaiting final results, according to CDC data released at the time.
To help increase the number of people being screened, the Food and Drug Administration issued emergency authorization for CDC-certified labs run by state health departments to begin processing swabs, but the CDC still declined to work with commercial labs.
As the first tests were processed at the state labs, technicians reported getting inconclusive results, which the CDC has said could be due to the test looking for signs of generic coronaviruses, of which there are many, rather than the specific virus that causes COVID-19.
By mid-February, only about a half-dozen state and local public health labs had reliable tests. But still, CDC Director Dr. Robert Redfield continued to insist his agency had developed “a very accurate test.”
As more sick people sought to be tested, many states were forced to limit access because of the flawed CDC test. On Feb. 24, exasperated officials at the Association of Public Health Laboratories sent a letter to the FDA, basically asking permission for state labs to develop their own. Within days, the FDA reversed its previous position and said both public and private labs could conduct testing.
By then, experts say, the opportunity to halt the relentless spread of the virus within the U.S. population had been lost.
On Feb. 29, only 472 patients had been tested nationwide, with just 22 cases confirmed, according to CDC data.
By comparison, South Korea had its first confirmed case of COVID-19 on Jan. 20, the same day as the U.S. Officials there used a test that focused on the same gene targets as the WHO test, according to website of a test manufacturer. They then quickly permitted private-sector labs to run the samples. As a result, a nation with less than one-sixth the population of the U.S. mobilized to test more than 20,000 people a day.
When asked why the U.S. didn’t adopt the WHOs more streamlined testing protocol, Trump administration officials falsely suggested the test used by much of the rest of the world isn’t reliable.
But Tarik Jašarević, a WHO spokesperson, told the AP that no problems have emerged.
“The test has been validated in three external laboratories, adapted by WHO and manufactured in line with international quality standards,” he said. “It has shown consistently good performance in laboratory and clinical use, and neither a significant number of false-positive nor false-negative results have been reported.”
Over the past two weeks, U.S. testing capacity has surged, with the private companies joining in. And with the increased testing has come a skyrocketing number of confirmed cases, zooming from 43 at the beginning of March to 15,219 when the CDC last updated its numbers Friday — an increase of more than 35,000 percent.
Jha estimates the U.S. should be testing between 100,000 and 150,000 people per day — figures he said should be obtainable given the country’s number of high-quality diagnostic labs.
“We certainly have the capacity. It’s just we’re not doing it,” Jha said. “We are up to about 40,000 tests per day now — and so we are moving in the right direction. Still far from where we need to be, but moving.”
For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia.
The vast majority of people recover from the new virus. According to the World Health Organization, people with mild illness recover in about two weeks, while those with more severe illness may take three to six weeks to recover.