Reports of a respiratory virus spreading in Wuhan, China, emerged in late 2019. After the number of cases outside China increased rapidly, the World Health Organization declared the novel coronavirus a pandemic on March 11.
With no cure or vaccine currently available, diagnostic testing is crucial to containing the spread of the virus.
Opportunities to mitigate the pandemic’s impact in the United States were lost amid bureaucratic delays and a breakdown in efforts to produce a reliable test kit at the Centers for Disease Control and Prevention.
Here are the major developments to understand what happened:
1. Contaminated tests
The failure by the CDC to quickly produce a test kit to detect the coronavirus was triggered by a glaring scientific breakdown at the CDC’s lab in Atlanta. The CDC facilities that assembled the kits violated manufacturing practices, resulting in contamination of one of the three test components used in the detection process. The troubled segment of the test was not critical to detecting the novel coronavirus, experts said. After false-positive results emerged, CDC officials took weeks to remove the unnecessary step from the kits.
2. Early warning signs on flawed testing ignored
Trump administration officials continued to rely on flawed CDC tests even as many lab scientists eager to help grew increasingly alarmed and exasperated by the federal government’s actions, according to emails and documents reviewed by The Washington Post. Scientists at academic, hospital and public health labs were frustrated by the bureaucratic demands that delayed their attempts to develop alternatives to the CDC test.
3. Limited testing
The initial decision to test only a narrow set of people and delays in expanding testing to other labs gave the virus a head start to spread undetected — and helped perpetuate a false sense of security that leaves the United States dangerously behind.
Initial guidelines were so restrictive that states were discouraged from testing patients exhibiting symptoms unless they had traveled to China and come into contact with a confirmed case, when the pathogen had by that point almost certainly spread more broadly into the general population. The limits left top officials largely blind to the true dimensions of the outbreak.
4. Complicated process and paperwork
As they struggled to make the test kit work, many public health labs realized they might succeed by eliminating one of its three main chemical components. But under the Food and Drug Administration’s emergency rules, they could use the test only as it was approved. Public health labs spent much of their time and energy on the FDA’s paperwork and data demands to win approval for their own tests.
5. Denial and dysfunction at the highest levels of government
The Trump administration received its first formal notification of the outbreak of the coronavirus in China on Jan. 3. And yet, it took 70 days from that initial notification for President Trump to treat the coronavirus pandemic seriously. The president consistently played down the threat and became a font of misinformation and confusion. While visiting the CDC in Atlanta on March 6, Trump incorrectly stated: “Anybody that needs a test, gets a test.” In fact, the nation is desperate for more testing, leading some states to conserve testing for only health-care workers.
Timeline of testing delays
A Chinese official officially informs CDC Director Robert Redfield of the outbreak. Redfield relays the report to Health and Human Services Secretary Alex Azar, and Azar notifies the Trump administration of the outbreak of the coronavirus.
The CDC begins planning for tests.
The CDC issues a health advisory informing state and local health departments about the outbreak and requesting that health-care providers ask patients with severe respiratory disease about travel history to Wuhan.
Chinese authorities submit to the World Health Organization the gene sequence data of the novel coronavirus, which is shared globally.
The first known person in the United States to be infected with the virus arrives in Seattle from China.
Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the CDC, says that Japan and Thailand are already using the genetic sequence to detect cases, adding: “We at the CDC have the ability to do that today — but we are working on a more specific diagnostic.’’
A Seattle man who had recently traveled to Wuhan is confirmed as positive for the coronavirus, becoming the first known infection case on U.S. soil. Messonnier says the CDC’s test kit was used to confirm the diagnosis of the man.
Technicians begin assembling a new batch of test kits, to be sent to 26 public health labs. In coming days all but two of those labs observe false-positive reactions that invalidate the test results.
Trump receives his first question about the coronavirus. Asked whether he is worried about a potential pandemic, Trump says: “No. Not at all. And we have it totally under control. It’s one person coming in from China. … It’s going to be just fine.”
The CDC shares the details of the U.S. test publicly.
The CDC raises its travel warning to the highest level, urging U.S. citizens to avoid all nonessential travel to China.
Azar touts the CDC test development: “This was really a historic accomplishment. Within one week — within one week, the CDC had invented a rapid diagnostic test.”
The WHO declares the outbreak a “public health emergency of international concern.”
The United States declares a public health emergency, triggering “emergency use authorizations.” Although this process is designed to speed the development of diagnostic tests and intended to keep the quality of testing high, it would eventually lead to delays in the development of coronavirus tests at clinical labs. The policy discouraged labs from developing in-house testing because it required the approval of the FDA to do so.
The CDC receives the first “emergency use authorization” from the FDA and prepares to distribute its test more widely. The CDC will ship out about 200 test kits to labs nationwide. It is the only test kit design available in the United States.
The CDC informs clinical labs of the new test kit.
The CDC begins to distribute 90 kits to state-run health labs. Meanwhile, the WHO reports it has shipped 250,000 test kits around the world.
Additional CDC test kits arrive at labs in New York, Nebraska, Colorado, Minnesota and elsewhere. By the end of the day, lab directors share bad news: They aren’t working properly. Through the weekend, lab directors share notes of the test and start to realize “this could be really bad.”
The CDC confirms the 13th coronavirus infection in the United States. At a political rally, Trump declared the virus will go away “by April, you know, in theory, when it gets a little warmer, it miraculously goes away.”
The first public hint of trouble with the test kits emerges when the CDC’s Messonnier mentions unspecified “issues’’ at the public health labs. “Some of the states identified some inconclusive laboratory results,’’ Messonnier tells reporters. “We have multiple levels of quality control to detect issues just like this one.”
Azar testifies in Congress that the CDC is working with five cities to add coronavirus testing to its regular flu surveillance to see whether “there is broader spread than we have been able to detect so far.” The labs are in Chicago, Los Angeles, New York, San Francisco and Seattle. However, the tests do not work.
Susan Butler-Wu, director of medical microbiology at the Los Angeles County and University of Southern California Medical Center, warns in an email in response to an inquiry from Congress: “We’re screwed from a testing standpoint if this thing takes off in the US.”
The United States has 15 confirmed cases, mostly in travelers returning from Wuhan.
An Association of Public Health Laboratories lab alert reports that there are issues with the CDC’s instruction for testing.
The CDC warns clinical laboratories across the country against testing on their own without FDA approval. Meanwhile, it has still not provided public health labs with instructions on how to modify its test to make it work properly.
Timothy Stenzel, a top FDA official for regulating diagnostic devices, meets with CDC officials in Atlanta to discuss the malfunctioning test kits. Stenzel will conclude that the problems are caused entirely by the CDC’s in-house manufacturing. He soon advises the CDC to assign any additional manufacturing of the kits to an outside contractor.
A coalition of public health labs asks the FDA for permission to make their own tests: “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories.”
In a congressional hearing, Sen. Patty Murray (D-Wash.) presses Azar, the HHS secretary, on whether the CDC test was faulty. He denies that the test does not work. But in a news briefing going on about the same time, the CDC’s Messonnier says that she was “frustrated” about problems with the test kits and that the CDC hoped to send out a new version to state and local health departments soon.
The FDA commissioner sends a letter to the coalition of public health labs that had asked for permission to make tests: “False diagnostic test results can lead to significant adverse public health consequences — not only serious implications for individual patient care but also serious implications for the analyses of disease progression and for public health decision-making.”
The CDC announces to public health labs that a workaround for the test has been approved.
Redfield, the CDC director, testifies to the House Foreign Affairs subcommittee on Asia, the Pacific and nonproliferation that the “CDC believes that the immediate risk of this new virus to the American public is low.”
On a conference call with a range of health officials, a senior FDA official lashes out at the CDC for its repeated lapses.
Jeffrey Shuren, the FDA’s director for devices and radiological health, tells the CDC that if it were subjected to the same scrutiny as a privately run lab, “I would shut you down.”
Privately, the CDC concludes that a “much broader” effort to testing is needed.
Dozens of clinical laboratory scientists from across the nation write to Congress asking for permission to create new tests, saying “this regulatory process is significantly more stringent than that required for every other virus we test for.”
Forty-seven days after the Chinese had distributed the virus’s genetic sequence, the CDC abandons the test’s once-touted third component. Messonnier announces that the component “can be excluded from testing without affecting accuracy.’’
The CDC announces the first U.S. death from the virus, a man in his 50s in Washington state. So far, the CDC and public health labs have tested only 3,999 people nationwide.
The FDA announces a new policy to make it easier for hospital laboratories to develop their own tests.
New York confirms the state’s first case of the coronavirus, announcing that a woman in her late 30s contracted the virus after traveling to Iran.
Trump tours the facilities at the CDC wearing a red “Keep America Great” hat. He says that the CDC tests are nearly perfect and that “anybody who wants a test will get a test.”
The WHO declares the coronavirus a pandemic.
Redfield tells the House Oversight and Reform Committee that the malfunction with the test kits was caused by either “a li’’ or an unspecified “biologic’’ factor. When pressed, Redfield says, “This is currently under an investigation at this point, and I think I’m going to leave it there.’’
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, testifies to Congress about the testing: “The system does not is not really geared to what we need right now,” he said. “Yes, it is a failure, let’s admit it.”
Trump declares a national emergency.
Federal health officials green light a point-of-care coronavirus test that can provide results in less than 15 minutes, using the same technology that powers some rapid flu tests.
Lack of widespread testing in the early weeks of the outbreak means the official U.S. death toll is an underestimation. The CDC count includes only deaths in which the presence of the coronavirus is confirmed in a laboratory test.