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FDA Worries COVID-19 Test Misses Too Many People Who Are Infected

STEVE INSKEEP, HOST:

Is a coronavirus test that the president promoted reliable? The Abbott ID Now test is a small machine, about the size of a toaster. And it's fast. Within 15 minutes, it is supposed to be able to spot people infected with coronavirus. But the Food and Drug Administration has now issued an alert about the test's accuracy. NPR health correspondent Rob Stein is covering this story. Rob, good morning.

ROB STEIN, BYLINE: Good morning, Steve.

INSKEEP: How big a deal would it be if this particular test proves not to be so good?

STEIN: Well, you know, Steve, this test has gotten a lot of attention because it's so fast. You know, President Trump has praised it a lot. In fact, it's the test used to screen people at the White House. And it's in big demand around the country. You know, the company that makes it has distributed at least 1.8 million of the tests. And it's cranking out 50,000 new tests every day to keep up with the demand. And we should point out that Abbott Laboratories is an NPR sponsor.

INSKEEP: Absolutely. But we're reporting on their problems here just the same. What is the FDA's concern about the test?

STEIN: The FDA issued a statement last night alerting the public that research is raising questions about the reliability of the tests, that it may produce inaccurate results. Specifically, the FDA is concerned about false negative results, meaning the test may tell people that they are negative when they're really positive. In other words, the test may miss too many people who are really infected.

INSKEEP: Why does the FDA have that concern?

STEIN: You know, the FDA isn't citing any specific research in this latest alert. But NPR reported back in April that researchers at the Cleveland Clinic had found that the Abbott ID Now test appears to be significantly less reliable than several of the other widely used tests. In their study, the test missed about 15 out of every hundred infections. And another study came out just this week from researchers at New York University. They found that the test could miss between a third and half of infections.

INSKEEP: Wow. Well, what does the company say when confronted with a study that finds that their test might be about as accurate as a coin flip?

STEIN: Yeah. So you know, Abbott is saying, no test is perfect. But it's basically standing by the ID Now. The company says the problem is with the studies, not the test. The way the specimens used in the studies were collected, handled, you know, stored and transported could have caused the problems. For example, the samples that were tested in the Cleveland Clinic study were stored in special fluids first instead of going directly into the testing machine like the company says they're supposed to. That would have diluted the specimens. And the company says other studies found the Abbott test to be just as accurate as any other test.

INSKEEP: OK. So they are questioning the tests of their test. But the FDA...

STEIN: Yeah.

INSKEEP: ...Has done this advisory. Does this mean we shouldn't be relying on the test at all?

STEIN: No, no. The FDA is not saying that. The FDA says the test can still be used. It can correctly identify many positive cases. But the FDA is saying that negative results may need to be confirmed with one of the other tests that have been shown to be highly reliable. And both Abbott and the FDA say they're working together to take a look at the test more closely.

INSKEEP: What are outside experts saying, Rob?

STEIN: I talked to Michael Mina about this. He's an infectious disease expert at Harvard. And he says the fast tests like the Abbott ID Now can definitely be useful as long as you realize that the speed may come with some tradeoffs. But he worries about relying on it to try to stop new outbreaks.

MICHAEL MINA: If you're really trying to prevent an outbreak from occurring, you know, one missed case can become a whole new transmission chain onward.

STEIN: You know, he also worries about the White House relying on this test. My colleagues reached out to the White House last night. But the White House didn't have any media comment.

INSKEEP: Rob, thanks so much.

STEIN: You bet, Steve.

INSKEEP: That's NPR health correspondent Rob Stein. Transcript provided by NPR, Copyright NPR.