As the first major COVID-19 outbreak was looming on the horizon in the U.S., scientists at the Centers for Disease Control and Prevention (CDC) in Atlanta were quickly developing a diagnostic test that could detect a COVID-19 infection.
When the test debuted in labs across the country on Feb. 6, it was meant to provide a crucial step in the detection and containment of the novel coronavirus in a standard epidemiological bid to prevent widespread outbreaks. If infections could be detected, they could be treated in isolation and contact tracing would be feasible.
NPR reports that this effort was thwarted when the CDC released it’s test kits because the tests had a high failure rate; the first COVID-19 diagnostic tests had a chance of being wrong 33 percent of the time. Despite this dismal evaluation, the public health agency opted to release the test kits anyway.
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The explosive report stated that in addition to the early warning of a problem with the tests, an internal review body from the CDC found problems in the Respiratory Viruses Diagnostic Laboratory, including “process failures, a lack of appropriate recognized laboratory quality standards, and organizational problems related to the support and management of a laboratory supporting an outbreak response.”
The first reports of faulty tests came from officials with the New York City Public Health Laboratory as the city was shaping up to be a hotspot for the virus. In the standard process of verifying the tests’ accuracy, lab technicians were reporting inconclusive results from reagents sent from the CDC, making it impossible to tell if a sample was positive or negative for the virus.
“It was very truly an 'oh, crap' moment," Jennifer Rakeman, the director of the New York City Public Health Laboratory told reporters. "These reagents aren't working; everybody is waiting for us all over the city to have this test online. We think we have more cases than we've been able to detect and the test isn't working.”
Without functional and accurate tests, it would be harder for people to know if they had a COVID-19 infection or not — and lead to further spread of the virus.
Eventually, the CDC took note of its faulty tests, and public health officials thought contamination might be the culprit behind inaccurate tests, NPR reports.
Upon further investigation, poor laboratory procedures, such as researchers wearing the same clothes in and out of testing rooms and disorganized testing ingredients, were observed. These can lead to contamination of chemicals and reagents used for testing.
More complicated issues emerged from the report, including that the head of the Respiratory Viruses Diagnostic Laboratory, Stephen Lindstrom, had constructed the diagnostic test similar to ones he previously created for other respiratory coronaviruses like SARS and MERS.
This is not inherently problematic, but mistakes were made within lab protocols, such as document control to verify test quality. This is critical to secure Emergency Use Authorization from the U.S. Food and Drug Administration for the COVID-19 tests. When the quality control tests at the lab revealed a 33 percent failure rate, Lindstrom decided not to recall them, issuing them to other labs.
One official at the Department of Health and Human Services told NPR reporters that a potential failure rate of 33 percent should have resulted in an immediate recall.
"The [quality control] records showed that the test had a problem," the official reportedly said. "Lindstrom signed off on a quality control that was clearly flawed. He should not have released that kit."
Notably, the CDC had also not set any benchmark success or failure rates for the debut COVID-19 diagnostic test, which made it difficult to gauge what percent chances of failure were acceptable.
NPR reports that Lindstrom did not comment, and the CDC said that the agency had “acknowledged and corrected mistakes along the way.”
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