Trump praises rapid coronavirus test despite FDA warning

President Donald Trump on Friday expressed confidence in the rapid coronavirus test used to screen White House staff and visitors, despite the results of a new study suggesting it may miss up to half of infections detected by other tests on the market.

“It’s a great test,” Trump told reporters during a news conference in the Rose Garden focused on vaccine development, referring to the 15-minute test produced by Abbott Laboratories.

“It’s a very quick test, and it can always be very rapidly double-checked if you’re testing positive or negative,” he said. “It can always be double-checked, but it’s a very good test. Very portable. Very quick.”

The president’s remarks came after researchers at New York University found earlier this week that Abbott’s test, run on a machine called ID NOW, did not identify many infections caught by Cepheid’s Xpert Xpress PCR test, which can return results in less than 45 minutes.

The preliminary research, which has not been peer-reviewed, also found that Abbott’s test missed one-third of infections when sample swabs were stored in chemicals meant to preserve samples, and more than 48 percent when sample swabs were kept dry.

Earlier Friday, Dr. Stephen Hahn, commissioner of the Food and Drug Administration, defended the data used to grant the test’s emergency use authorization as “very robust,” but said his agency regularly explores additional data such as the NYU research to “make revisions to our original decision.”

“In this case, what we’re saying is there are some data to suggest that there may be inaccuracies, false negatives, with the Abbott test. However, there are many users who have contacted us and have not had this problem,” Hahn told “CBS This Morning.”

“So FDA is digging into it, and we’re working with Abbott to actually look at what data are available to get the most up-to-date and accurate information about the test’s performance,” he added.

Hahn also said the FDA continues to recommend the use of Abbott’s test, which is available on the commercial market, but “we want to make sure that providers have the information about the operating characteristics of tests — about what the test does.”

On Thursday, the agency posted a public alert stating that Abbott’s test might return false-negative results which “may need to be confirmed” by other testing methods.

That warning followed Abbott’s move last month to amend its instructions for the test to caution against transporting samples in chemicals, after a study from the Cleveland Clinic found that doing so caused a false-negative rate of up to 15 percent.

Last week, Abbott’s test reported that one of Trump’s personal valets and Katie Miller, Vice President Mike Pence’s press secretary and the wife of White House adviser Stephen Miller, had both tested positive for Covid-19 — prompting Trump and Pence to limit their in-person contact in recent days and Hahn to enter self-quarantine after exposure to Miller.

“She was tested very recently and tested negative. And then today, I guess for some reason she tested positive,” Trump said of Miller at the time, complaining she had “tested positive out of the blue” and arguing that “this is why the whole concept of tests aren’t necessarily great.”

The White House Management Office has since issued a memo requiring West Wing staffers to wear masks or other face coverings at all times in the building, except at their own desks and the majority of staff now undergo daily testing.

Pressed Friday on whether the White House would continue using Abbott’s test in light of the latest research, Hahn said, “We’re providing guidance to the White House regarding this test. We have been on an ongoing basis, and we will continue to do that. That will be a White House decision.”