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March 10, 2020

Why doesn't America have enough coronavirus tests?

Daily Briefing

    Delays, glitches, and missteps over a six-week period undermined the U.S. response to the new coronavirus outbreak, according to experts and federal government health officials, and despite recent progress, delays in testing persist.

    Our analysis: The 'recurring themes' of disease outbreaks

    The state of the new coronavirus in the US

    Reports of the new coronavirus, which causes the disease known as COVID-19, surfaced in early December 2019 in Wuhan, China. CDC reported the first case of the coronavirus in the United States in late January. The number as of Tuesday morning had grown to 747 and federal officials expect that figure to increase.

    In recent weeks, the federal government has come under scrutiny for its response to the virus, particularly when it comes to testing efforts. The main points of criticism have centered on faulty tests from CDC, the rules about which labs can perform tests, and the criteria under which patients can be tested, which CDC updated last week. According to the Washington Post, these issues, taken together, "gave the virus a head start to spread undetected."

    Politico, the Post, and The Atlantic separately interviewed dozens of laboratory experts and former and current government officials to paint a picture of where the United States' coronavirus response efforts faltered.

    Faulty tests hindered efforts to detect the virus

    According to the sources, the problem began with the United States' process for developing a diagnostic test. 

    While China, Germany, and several other countries also opted to develop their own testing kits for the new coronavirus, the turnaround time was longer in the United States.  

    In the United States, CDC and FDA, working closely with HHS officials, take the lead on developing new diagnostic tests to ensure tests are accurate and reliable. But, according to the Post, the federal officials' messaging and approach discouraged hospitals from developing and using their own in-house testing kits because they would need to obtain FDA's permission to use them. That meant screening needed to be "rationed," former FDA Commissioner Scott Gottlieb explained in a tweet dated Feb. 2.

    The next problem came in the initial batch of tests. On Feb. 6 and 7, CDC shipped testing kits to public health labs, but the labs soon reported issues with the diagnostics, which further limited screening. On Feb. 12, CDC announced some of the tests provided labs with inconclusive results. The problem, which involved an ingredient in the test kit, had further slowed the United States' ability to test and confirm COVID-19 diagnoses, requiring most of the testing to be conducted at CDC's headquarters in Atlanta.

    A federal official, who spoke with the Post on the condition of anonymity, said the issue could have stemmed from contamination in the CDC lab where the tests had been developed or design flaw.

    Once CDC became aware of the issue, the agency decided to fix the diagnostic test instead of switching to the diagnostic tests being used by other countries—a move that drew criticism from experts. However, CDC said applying for an FDA authorization to use tests from other countries and then validating and manufacturing the test would have taken the agency longer than fixing the issues with the agency's already validated tests.

    Epidemiologists questioned narrow testing criteria

    Another reason CDC decided to not adopt tests being used in countries is because U.S. public health officials believed they had enough tests. At the time, CDC's narrow criteria for testing patients—which only applied to people who had recently traveled to China or had close contact with a confirmed case and were exhibiting symptoms of COVID-19—and the small number of confirmed cases in the country made officials believe they had an adequate number of tests.

    However, Jeffrey Engel, executive director of the Council of State and Territorial Epidemiologists, said epidemiologists advising CDC in early to mid-February had already begun to discuss whether testing needed to be expanded in order to determine whether the virus was spreading in communities among patients believed to have a cold or the flu.

    CDC has since broadened the testing criteria. But it wasn't until last Thursday that CDC Director Robert Redfield said the agency will allow testing "[w]hen a clinician or public health individual suspects coronavirus."

    Though testing is becoming more widely available, there continues to be confusion and frustration over testing.

    An ED physician who spoke to the Los Angeles Times on the condition of anonymity pointed out some of the risks associated with limited testing. The doctor said, "Last night I had a patient with clear coronavirus symptoms, but the health department didn't think he should be tested. I went from that patient into the next room, where I had an 80-year-old, immune-compromised, diabetic patient. If I'm taking coronavirus in there, it's mild for me, but it's deadly for her."

    Hospitals, labs grew concerned over test delays

    The issues and delays caused academic hospitals, which have the capacity to develop laboratory tests and regularly produce diagnostics for patients, to feel concerned about the country's reliance on CDC tests. Many considered asking FDA to develop their own diagnostic tests, but hospital officials noted they did not have the expertise or resources, including access to the virus, to file the complex application required during a public health emergency, the Post reports.

    On Feb. 18, CDC reminded hospitals not to develop their own tests absent an "emergency use authorization" from FDA, even though the number of diagnostics available remained limited.

    But by Feb. 25, public health labs had become "desperate" and they requested FDA's permission to develop their own diagnostic tests, the Post reports. FDA approved the request and allowed a partial CDC test with only two of the three original components to be distributed to public health labs. As soon as more tests became available, labs began to confirm more cases of the virus.

    On Feb. 29, FDA released a new policy to give hospitals more flexibility to develop their own diagnostic tests. Stephanie Caccomo, an FDA spokesperson, said, "This outbreak and our response is dynamic and evolving. As the situation changes, we are being flexible as we execute policies intended to protect public health."

    By Friday, public health labs had received tests for as many as 75,000 people and more than 1.1 million tests had been sent to other labs, including academic medical centers and commercial laboratories, the Post reports.

    New tests are also emerging from the private sector, the Post reports. Both Quest Diagnostics and LabCorp separately said they'd have testing kits available this week.

    'You can't get back six weeks of blindness': Experts discuss where things went wrong

    Regarding the missteps, Jeremy Konyndyk, a senior policy fellow at the Center for Global Development who oversaw the international response to Ebola under former President Barack Obama's administration, said, "They've simply lost time they can't make up. You can't get back six weeks of blindness. To the extent that there's someone to blame here, the blame is on poor, chaotic management from the White House and failure to acknowledge the big picture."

    Gottlieb said, "The key in a crisis like this is to take an all-of-the-above approach, whether we're dealing with diagnostics or therapeutics." Gottlieb said HHS and FDA could have decided early on to use a more comprehensive strategy to develop a diagnostic test for the coronavirus and increase the volume of available tests.

    A federal health official told the Post, "Most laboratories were anticipating a more rigorous FDA stance, and had not been leaning forward for tests that could have been made more useful. We were working under the rubric and framework they set in place, and had they known things could be more flexible" labs might have taken more immediate action to develop new tests (Meyer/Madrigal, The Atlantic, 3/6; Kenen, Politico, 3/6; Johnson/McGinley, Washington Post, 3/7; Baumgaertner/Karlamangla, Los Angeles Times, 3/7; Smith et al., New York Times, 3/10).

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