![]() ![]() Low-level contamination was to blame for a problem with a Middle East respiratory syndrome CDC test years ago. 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. We need that other tool, we need that test," she said. 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. We think we have more cases than we've been able to detect and the test isn't working." ![]() "These reagents aren't working everybody is waiting for us all over the city to have this test online. "It was very truly an 'oh, crap' moment," Rakeman said. Rakeman began calling other labs to see if they were experiencing the same problem, and they said they were. 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. 8, hours after her lab started verifying the test kits, Rakeman said she began receiving panicked emails from colleagues. 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."īy Feb. 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. 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. Each cardboard container held four tiny vials of chemicals that, when used properly, were meant to confirm the presence of the virus.Ī technician prepares coronavirus test samples on New York's Long Island. 6, according to the CDC timeline in the review. The CDC's coronavirus test kits began arriving at the 100 or so public labs across the country in small white boxes on Feb. 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. 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. A spokesman would only say that the agency had "acknowledged and corrected mistakes along the way." The CDC declined to make Lindstrom or anyone else available for an interview and declined to discuss the unreleased internal review. 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. ![]() Investigations Irregularities In COVID-19 Reporting Contract Award Process Raise New Questions 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. But an internal CDC review obtained by NPR confirms that lab officials decided to release the kit anyway. 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 NPR has learned the results of that final quality control test suggested something troubling - it said the kit could fail 33% of the time. 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. 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. An internal Centers for Disease Control and Prevention review obtained by NPR says the wrong quality control protocols were used.Ĭenters for Disease Control and Prevention via AP The flawed coronavirus test kits went out to public laboratories in February. ![]()
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