CDC Report: Officials Knew Coronavirus Test Was Flawed But Released It Anyway

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The flawed coronavirus test kits went out to public laboratories in February. An internal Centers for Disease Control and Prevention review obtained by NPR says the wrong quality control protocols were used.

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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.

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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.

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CDC Director Robert Redfield confers with Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a Jan. 28 press conference in Washington, D.C., on the public health response to the coronavirus.

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HHS officials said there was nothing intrinsically wrong with the test Lindstrom’s lab built but had Lindstrom been at the infectious disease lab longer, he might have pulled a MERS test out of the freezer and used that as the template for a coronavirus test instead because it had more in common with a respiratory virus than influenza did.

Because the respiratory disease lab had fewer entrenched systems than Lindstrom’s previous lab, the review also found that basic mistakes were made. «The absence or failure of document control to ensure the use of a single verified correct test quality control procedure matching [Emergency Use Authorization] procedure, the review said, «resulted in deficiencies.

The FDA had required a particular protocol be followed when designing the test, and the lab didn’t seem to be using the correct one, it said. «The first round of [quality control] for final kit release used an ‘incorrect’ testing procedure, it said. «Later in the timeline, detection of a 33 percent kit failure using the correct quality control protocols «did not result in a kit recall or a performance alert.

Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, said she was surprised that Lindstrom’s lab would be called out for something as basic as quality control. That hasn’t been her experience. «I’ve done studies with Steve, and he’s meticulous in so many ways so the documentation failure is really surprising, she said.

When the lab ran the very last quality control test, using the correct Emergency Use Authorization procedures and showing a possible 33% failure rate, it was Feb. 6, according to the review. The kits, with their four little vials, were already in their boxes. There was time to recall them before they went out, but Lindstrom decided not to do that, three officials familiar with the review said.

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CDC headquarters in Atlanta in April. The CDC review made some recommendations so such a failure doesn’t happen again.

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CDC headquarters in Atlanta in April. The CDC review made some recommendations so such a failure doesn’t happen again.

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One HHS official told NPR this shouldn’t have been a tough call. «The QC records showed that the test had a problem, the official said. «Lindstrom signed off on a quality control that was clearly flawed. He should not have released that kit.

Wroblewski agreed. «The thing that hangs me up most is probably the 33% and not recalling or not immediately going to remanufacture or something at that point, she said, «because 33% is clearly a lot.

Compounding the problem, officials said, was the fact that the CDC had not established specific benchmarks for the test. There was not, for example, an agency directive that said the test needed to be correct some specific percentage of the time before it could be released.

Obviously, the CDC would like the tests to be completely accurate, one official told NPR, but something less than that is typically acceptable, particularly during a public health crisis.

Because there was no benchmark set for acceptance, it became Lindstrom’s call. He appears to have decided either that the last quality control test was wrong or that the 33% failure rate was acceptable, officials said.

Ramping up testing

The inspector general for HHS is also investigating why that first coronavirus test failed and has not yet completed its report.

The CDC review has some recommendations so a failure such as this one doesn’t happen again. Among them: setting specific criteria that must be met before test kits can go to public labs, and now requiring that an outside group reviews all the CDC tests.

NPR has confirmed that Lindstrom is no longer in the respiratory disease lab, and the CDC has effectively removed all the leadership from the division of viral diseases that oversaw the lab. A CDC spokesman declined to discuss CDC personnel issues.

NPR’s Monika Evstatieva and Barbara Van Woerkom contributed to this report.