Source npr.org November 6, 20205:06 AM ET
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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.
In addition to learning of the early warning, reviewers determined the Respiratory Viruses Diagnostic Laboratory, run by a highly regarded scientist named Stephen Lindstrom, was beset with problems, 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 review said.
The CDC declined to make Lindstrom or anyone else available for an interview and declined to discuss the unreleased internal review. A spokesman would only say that the agency had "acknowledged and corrected mistakes along the way."
Like building a house without a hammer
In late January, the tally of confirmed COVID-19 cases seemed relatively manageable — about 4,500 confirmed cases worldwide and under a dozen confirmed in the continental United States. In a pandemic, public health officials say, the best hope to keep the numbers low is to determine who else might have the virus and where it was spreading and then concentrate efforts on those areas first.
The CDC's coronavirus test kits began arriving at the 100 or so public labs across the country in small white boxes on Feb. 6, according to the CDC timeline in the review. Each cardboard container held four tiny vials of chemicals that, when used properly, were meant to confirm the presence of the virus.
The New York City Public Health Laboratory was in that first wave of labs receiving the kits, and its director, Jennifer Rakeman, said her technicians began trying to verify the test right away. Verification is a standard protocol; it involves following detailed instructions to ensure the tests work the same way in an outside lab as they do at the CDC labs in Atlanta.
A technician prepares coronavirus test samples on New York's Long Island. The head of New York City's public labs said fighting the virus without a test was like building a house with a saw but no hammer.
The first three vials in the box were specific to the coronavirus, and the fourth was a control that let the labs know the specimen they were examining was a good one. Essentially, Rakeman said, it lets you know if the swab went all the way up a patient's nose and wasn't just "waved in the air."
By Feb. 8, hours after her lab started verifying the test kits, Rakeman said she began receiving panicked emails from colleagues. Something, they said, was wrong: They had run the tests dozens of times but were getting inconclusive results from two of the reagents, or chemicals, in the vials.
Rakeman began calling other labs to see if they were experiencing the same problem, and they said they were. "It was very truly an 'oh, crap' moment," Rakeman said. "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."
She said trying to battle COVID-19, which was just starting to rage through New York, without a test was like trying to build a house with a saw but no hammer. "And we need that hammer. We need that other tool, we need that test," she said.
When the complaints reached the CDC, leaders at the lab said they suspected the problem was contamination, according to Department of Health and Human Services officials who spoke to them at the time. Low-level contamination was to blame for a problem with a Middle East respiratory syndrome CDC test years ago. Microscopic residue could roil and ruin a sensitive test such as the one built to find the coronavirus.