On Feb. 6, a scientist in a small infectious disease lab on the Centers for Disease Control and Prevention campus in Atlanta was putting a coronavirus test kit through its final paces. The lab designed and built the diagnostic test in record time, and the little vials that contained necessary reagents to identify the virus were boxed up and ready to go. But NPR has learned the results of that final quality control test suggested something troubling — it said the kit could fail 33% of the time.
Under normal circumstances, that kind of result would stop a test in its tracks, half a dozen public and private lab officials told NPR. But an internal CDC review obtained by NPR confirms that lab officials decided to release the kit anyway. The revelation comes from a CDC internal review, known as a "root-cause analysis," which the agency conducted to understand why an early coronavirus test didn't work properly and wound up costing scientists precious weeks in the early days of a pandemic.
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While the CDC and HHS were trying to determine what was wrong with the kits, public labs were still waiting for something they could use. "We waited another month before we had testing available," Rakeman told NPR.
28 FEB 2020
The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), in contrast, has done only 459 tests since the epidemic began.
Buzzfeed reports on the HHS investigation of the testing failure (heavily excerpted, I recommend reading this in full):
Overconfidence. The CDC did not initially rely on tests already in use in other countries, because officials thought they could build a better one. Agency leaders did not coordinate with outside manufacturers for support, and they never performed any validations of previously developed tests that could have been used as backup.
The test catastrophe documented by the HHS investigation has led to unprecedented demands from former federal science officials to overhaul the CDC in order to avert another such disaster.
On Jan. 16, the World Health Organization published instructions from the German Center for Infection Research for its successful COVID test. Dozens of countries worldwide began to widely manufacture and distribute it.
Why didn't the CDC team follow suit? Lu, according to the interview notes, said that the health agency scientists thought they could make a better one. The CDC's test mimicked the one it had made for MERS in 2012. "Our MERS assay performed better than WHO's," Lu recounted. And, she added, "We were racing against the clock."
A CDC employee familiar with the development of the test told BuzzFeed News that the health agency had also felt it would be better to have both US and German types of tests available worldwide — and that copying the WHO test would not have been politically possible under Donald Trump. "Imagine the backlash we would have had if CDC had said, 'Hey, yeah, let's use a German test,'" the CDC employee said.
The CDC test was intended only as a tool for the public health agency to detect outbreaks, not to diagnose every sick person walking into an emergency room. Instead, in the early days of the pandemic, it became the only legal US test for every patient.
That's in part because no one else stepped up: Large test makers, burned before by past demands for unused and unsold Ebola and Zika virus tests, had no incentive to start making tests. And smaller academic and medical center labs were daunted by the paperwork requirements to validate tests: 240 pages' worth of patient testing data.
Facing what was now looking like an inescapable pandemic, the CDC's unreliable three-part test was scrapped. On Feb. 26, the agency gave public health labs permission to nix the contaminated N3 component from tests they had already received, and it began sending out kits with only N1 and N2. The N1 reagents were no longer throwing off false positives by this point.
On Feb. 29, the FDA finally gave them permission to use their own tests. "We should have been permitted to do testing in January," said Geoffrey Baird, a laboratory medicine expert at the University of Washington who reviewed the investigation notes for BuzzFeed News. "We weren't. We were waiting and had this laboratory-developed test ready, like everyone else who knew anything about this, the week after the Chinese published the sequence."
Trump visited the CDC on March 6. Just a few hours before he'd arrived, the HHS investigators ended their three days of interviews with lab personnel. But with the cameras rolling at CDC, Trump falsely promised that "anybody that wants a test can get a test."
In reality, only about 2,000 tests were performed on that date. Meanwhile, the country fell into uncontrolled spread of the virus.
The fact that the CDC was the only group in the US responsible for making tests made the failure even more consequential, Baird said. But he argued that the wider lack of tests wasn't the CDC's fault. Instead, he blamed the FDA, which held on to a bureaucratic EUA process that stymied fast action in the face of a public health emergency. "There was a feeling this wasn't going to be a major outbreak early on," a CDC lab official told BuzzFeed News, saying that senior leaders didn't do enough to encourage industrial test manufacturers to mobilize.
Other countries with different health systems had started efforts back in January (the validated WHO test protocol was released Jan 16) to enable as many commercial labs as possible to run Covid tests on their machines, increasing capacity to a point where everyone who was at risk could be tested if they showed symptoms. The USA were clearly capable of the same from a scientific standpoint, but it looks like the public health bureaucracy (CDC, FDA) wasn't up to the task of making it happen.