In the absence of currently available treatment or vaccine, diagnostic tests are essential to contain the spread of the virus.
Opportunities to mitigate the impact of the pandemic in the United States have been lost due to bureaucratic delays and the collapse of efforts to produce a reliable test kit at the Centers for Disease Control and Prevention.
Here are the main developments to understand what happened:
1. Contaminated tests
The CDC’s failure to quickly produce a test kit to detect the coronavirus was triggered by a glaring scientific breakdown at the CDC’s laboratory in Atlanta. The CDC facilities that assembled the kits violated manufacturing practices, resulting in the contamination of one of the three test components used in the detection process. The troubled segment of the test was not critical for detecting the new coronavirus, experts said. After false positive results emerged, CDC officials took weeks to remove the unnecessary step from the kits.
2. Early warning signs of ignored defective tests
Trump administration officials continued to rely on flawed CDC tests even as many laboratory scientists eager to help were increasingly alarmed and exasperated by federal government actions, according to emails and reports. documents reviewed by the Washington Post. Scientists in university, hospital and public health laboratories have been frustrated by bureaucratic demands that have delayed their attempts to develop alternatives to the CDC test.
3. Limited trials
The initial decision to test only a small set of people and the delays in extending testing to other laboratories gave the virus a head start to spread undetected – and helped perpetuate a fake feeling of security that leaves the United States dangerously behind.
The original guidelines were so restrictive that states have been discouraged from testing patients with symptoms unless they have traveled to China and been in contact with a confirmed case, while the pathogen was at that time almost certainly spread more widely among the general population. The boundaries have left senior officials largely blind to the true dimensions of the epidemic.
4. Complicated processes and paperwork
As they struggled to operate the test kit, many public health laboratories realized that they could be successful in eliminating one of its three main chemical components. But under Food and Drug Administration emergency rules, they could only use the test if it had been approved. Public health labs have spent much of their time and energy on paperwork and FDA data requests for approval of their own tests.
5. Denial and dysfunction at the highest levels of government
The Trump administration received its first official notification of the coronavirus epidemic in China on January 3. Yet it took 70 days from this initial notification for President Trump to seriously address the coronavirus pandemic. The president constantly downplayed the threat and became a source of misinformation and confusion. During his visit to the CDC in Atlanta on March 6, Trump said incorrectly: “Anyone who needs a test, gets a test. In fact, the nation is desperate for more tests, leading some states to keep the tests only for healthcare workers.
Chronology of test delays
Information about a new virus causing mysterious pneumonia is starting to leak from Wuhan, China.
A Chinese official officially informs CDC director Robert Redfield of the epidemic. Redfield forwards the report to Secretary of Health and Human Services, Alex Azar, and Azar informs the Trump administration of the coronavirus outbreak.
The CDC begins planning the tests.
The CDC is issuing a health advisory informing state and local health departments of the outbreak and asking health care providers to ask patients with severe respiratory illnesses for a travel history to Wuhan.
Authorities in China are submitting genetic data for the new coronavirus to the World Health Organization, which is shared worldwide.
The first known person in the United States to become 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 already use the genetic sequence to detect cases, adding: “We at the CDC have the capacity to do this today. today – but we are working on a more specific diagnosis. “
A CDC report refers to the first positive case of coronavirus in the United States.
January the 21st
A Seattle man who recently traveled to Wuhan is confirmed positive for coronavirus, becoming the first known case of infection on American soil. Messonnier said the CDC test kit was used to confirm the man’s diagnosis.
Technicians begin to assemble a new batch of test kits, which will be sent to 26 public health laboratories. In the coming days, all but two of these laboratories are observing false positive reactions which invalidate the test results.
Trump receives his first question on the coronavirus. When asked if he was worried about a possible pandemic, Trump replied, “No. Not at all. And we have it totally under control. He’s a person from China. … It will be very good. ”
The CDC publicly shares the details of the American test.
The CDC raises its travel warning to the highest level, urging American citizens to avoid non-essential travel to China.
Azar praises the development of the CDC test: “It was truly an historic achievement. Within a week – within a week, the CDC had invented a rapid diagnostic test. “
WHO declares the epidemic a “public health emergency of international concern.
The United States declares a public health emergency, triggering “emergency use clearances”. Although this process is designed to accelerate the development of diagnostic tests and intended to maintain the quality of tests at a high level, it would ultimately lead to delays in the development of coronavirus tests in clinical laboratories. The policy discouraged laboratories from developing internal testing because it required FDA approval to do so.
The CDC receives the first “emergency use authorization” from the FDA and is preparing to distribute its test more widely. The CDC will send approximately 200 test kits to laboratories across the country. It is the only test kit design available in the United States.
The CDC informs clinical laboratories of the new test kit.
The CDC is starting to distribute 90 kits to state-run health laboratories. Meanwhile, WHO reports having shipped 250,000 test kits worldwide.
Additional CDC test kits arrive in laboratories in New York, Nebraska, Colorado, Minnesota and elsewhere. At the end of the day, the laboratory directors share bad news: they are not functioning properly. Throughout the weekend, lab directors share notes on the test and begin to realize “it could be really bad.”
The CDC confirms the 13th coronavirus infection in the United States. At a political rally, Trump said the virus would go “by April, you know, in theory, when it gets a little warmer, it will miraculously disappear.”
The first public sign of a problem with test kits emerges when the CDC’s Messonnier mentions unspecified “problems” in public health laboratories. “Some states have identified inconclusive laboratory results,” Messonnier told reporters. “We have multiple levels of quality control to detect problems like this.”
Azar testified to Congress that the CDC is working with five cities to add coronavirus tests to its regular flu surveillance to see “if there is a wider spread than we have been able to detect so far. The laboratories are located in Chicago, Los Angeles, New York, San Francisco and Seattle. However, the tests do not work.
Susan Butler-Wu, director of medical microbiology at Los Angeles County and University of Southern California Medical Center, warns in an email in response to a request from Congress: “We are screwed up about testing if this thing takes off in the US. “
The United States has 15 confirmed cases, mainly among travelers returning from Wuhan.
A laboratory alert from the Association of Public Health Laboratories reports that there are problems with CDC’s instructions for testing.
The CDC warns clinical laboratories across the country against testing by themselves without FDA approval Meanwhile, it still has not provided public health laboratories with instructions on how to modify its test to make it work properly.
Timothy Stenzel, a senior FDA official for the regulation of diagnostic devices, meets with CDC officials in Atlanta to discuss defective test kits. Stenzel will conclude that the problems are entirely due to the internal manufacture of the CDC. He soon advised the CDC to entrust any additional manufacturing of the kits to an outside contractor.
A coalition of public health laboratories is asking the FDA for permission to do its own tests: “We are now in many weeks of the answer with still no diagnostic or surveillance tests available outside the CDC for the vast majority of our member laboratories. “
At a congressional hearing, Senator Patty Murray (D-Wash.) Insists Azar, the secretary of the HHS, to find out if the CDC test was defective. He denies that the test does not work. But in a press conference taking place around the same time, the CDC messenger says she was “frustrated” with the problems with the test kits and that the CDC hoped to send a new version to health services soon. local and state.
FDA commissioner sends letter to coalition of public health labs who asked for permission to test: “False diagnostic test results can have serious negative public health consequences – not just serious implications for the care of individual patients, but also have serious implications for the analysis of disease progression and for public health decision-making. “
The CDC announces to public health laboratories that a workaround for the test has been approved.
CDC Director Redfield Tells The House Foreign Subcommittee On Asia, The Pacific And Non-Proliferation That “The CDC believes the immediate risk to the American public of this new virus is low” .
In a conference call with a range of health officials, a senior FDA official blamed the CDC for his repeated failures.
Jeffrey Shuren, the FDA’s director for devices and radiation health, tells the CDC that if it were subjected to the same testing as a private laboratory, “I would shut you down.”
In private, the CDC concludes that a “much broader” test effort is needed.
Dozens of clinical laboratory researchers across the country are writing to Congress asking for permission to create new tests, saying “this regulatory process is much more rigorous than that required for all the other viruses we test.”
Forty-seven days after the Chinese distributed the genetic sequence of the virus, the CDC drops the once-touted third component of the test. Messonnier announces that the component “can be excluded from the tests without affecting accuracy. »»
The CDC announces the first American death of the virus, a man in his 50s in Washington State. So far, the CDC and public health labs have only tested 3,999 people nationwide.
The FDA announces a new policy to make it easier for hospital laboratories to develop their own tests.
1st of March
New York confirms the first case of coronavirus in the state, announcing that a woman in her late 30s contracted the virus after traveling to Iran.
Trump visits CDC facilities with a red “Keep America Great” hat. He says the CDC tests are almost perfect and that “anyone who wants a test will get a test”.
WHO declares the coronavirus a pandemic.
Redfield told the House Oversight and Reform Committee that the malfunction of the test kits was due to either an “li” or an unspecified “biological” factor. When pressed, Redfield said, “This is under investigation, and I think I will stop there. “
12th of March
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, testifies to Congress about the tests: “The system doesn’t really work for what we need today,” he said. “Yes, it was a failure, let’s face it. “
Trump declares a national emergency.
Federal health authorities are giving the green light to a point-of-care coronavirus test that can deliver results in less than 15 minutes, using the same technology that allows some rapid flu tests.
The lack of widespread testing in the first weeks of the epidemic means that the official death toll in the United States is an underestimate. The CDC count only includes deaths for which the presence of the coronavirus is confirmed in a laboratory test.