An unreleased CDC review obtained by NPR shows that lab officials knew an early coronavirus test kit had a high failure rate. They decided not to recall it and sent it to the nation's labs anyway.



We are also tracking the pandemic where the United States remains the world leader in cases and deaths. This election week, the U.S. surpassed 100,000 cases per day for the first time. And today, we have more of the story of how we got here. An NPR investigation has revealed news of a failure of coronavirus testing. Early in the pandemic in February, a test designed by the Centers for Disease Control did not work, which setback U.S. efforts. Now, an internal investigation from the CDC obtained by NPR shows the microbiologist who produced that test knew it was flawed and sent it to the nation's labs anyway. Here's NPR's Dina Temple-Raston.

DINA TEMPLE-RASTON, BYLINE: The COVID tests arrived in New York City on a Friday in early February when there were just a handful of confirmed cases in the United States.

JENNIFER RAKEMAN: It was a little box with a few little tiny screw cap test tubes in it.

TEMPLE-RASTON: That's Jennifer Rakeman. She's the director and assistant commissioner of the New York City Public Health Laboratory. And she was one of the first people to learn that the COVID-19 test the CDC sent to labs around the country actually didn't work. It became clear as soon as her lab technicians tried to verify the test.

RAKEMAN: Well, the emails from the lab staff were saying something looks not quite right. Call us.

TEMPLE-RASTON: What jumped out at them - when the lab ran specimens that were supposed to be negative, the tests seemed to indicate those samples contained a low level of the coronavirus.

RAKEMAN: It was truly an oh crap moment. Like, what are we going to do now? Everybody is waiting for us all over the city to have this test online. Everybody was holding on to this moment that we were going to have a test, and now we don't have it.

TEMPLE-RASTON: And they wouldn't have it, it turns out, until nearly a month later in March, which meant public health officials were hobbled from the earliest days of the pandemic.


UNIDENTIFIED REPORTER #1: Health officials across the country reporting a shortage of tests despite promises from the federal government...

UNIDENTIFIED REPORTER #2: This comes amid growing criticism that the delay in testing may have compromised the nation's ability to detect cases.

TEMPLE-RASTON: The CDC lab appeared to have failed in a spectacular way, though as recently as July, the agency was still saying the test didn't have a problem. Here's CDC Director Robert Redfield.


ROBERT REDFIELD: When we did try to expand that test to give it to each of the local health departments, there was a manufacturing problem in one of the reagents that had to be corrected. That took about five weeks.

TEMPLE-RASTON: But the agency's internal review suggests that isn't so. It determined that the scientists who built the test used the wrong quality control procedures. The review also found problems with the lab's quality standards and problems with the management of the lab more generally. The infectious diseases lab was run by a highly regarded scientist, Dr. Stephen Lindstrom. He'd been an expert in influenza at the CDC for more than a decade and became director of the Infectious Diseases Lab a couple of years ago. The CDC declined to make Lindstrom available for an interview and declined to comment for the story. But 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 in a report for something basic like quality control. That hadn't been her experience with him.

KELLY WROBLEWSKI: I have done studies with Steve, and he's meticulous. And so the documentation failure was really surprising.

TEMPLE-RASTON: So that was one thing the CDC found, a problem in the way the lab was run. The second thing the review found was that right before the tests were going to be sent to hundreds of public labs, the lab ran a final check that showed the kits might not work a third of the time. But rather than pull the kits back, lab officials sent them out anyway. Kelly Wroblewski again.

WROBLEWSKI: The thing that hangs me up the most is probably the 33% and not recalling or not immediately going to remanufacture or something at that point because 33% is clearly a lot.

TEMPLE-RASTON: To ensure this never happens again, the CDC review has recommendations for change. It sets clear criteria that must be met before the kits can be sent out rather than allowing lab directors to make a judgment call. An outside group must review all the CDC test kits before they go out. Stephen Lindstrom, for his part, no longer runs the lab. And none of the same people who oversaw the making of that test are in charge now. New York's Rakeman says that month they lost was crucial.

RAKEMAN: The outcome and the response nationally, as well as in New York City, would have been different if we were able to have all the tools we needed in our toolbox earlier than we did.

TEMPLE-RASTON: Not having the CDC tests, she said, was like building a house with just a saw and not a hammer. They needed a hammer, she said. Dina Temple-Raston, NPR News.

(SOUNDBITE OF SOUND REMEDY'S "LIBERATION") Transcript provided by NPR, Copyright NPR.