Dive Brief:

• President Donald Trump's former FDA head Scott Gottlieb on Sunday questioned the White House's use of Abbott's rapid point-of-care COVID-19 test amid the news the president and the first lady had tested positive for the coronavirus.
• Appearing on CBS program Face the Nation, the outspoken former commissioner said while Abbott's platform is a "very good test when used appropriately" the White House leveraged the diagnostic in a way for which it was not intended. Gottlieb suggested Cepheid's more accurate GeneXpert rapid molecular test would probably have been "more fit to purpose" in the West Wing given that Trump and his aides relied heavily on daily testing.
• Further, in the absence of mask wearing and social distancing, Gottlieb called into question the White House's overreliance on Abbott's ID Now to protect Trump. "They needed a zero-fail testing protocol because they weren't taking any precautions beyond testing people who are going to be in contact with the president. And that requires multiple layers of testing," Gottlieb said, which was never put in place by the administration.

Dive Insight:

Cepheid on March 21 announced it was the first manufacturer to receive an FDA emergency use authorization for a rapid point-of-care test for the novel coronavirus. The test, which runs on the company's GeneXpert systems, takes about 45 minutes to deliver results. However, when Abbott got the FDA's nod a week later for its five-minute ID Now test, it quickly became the White House's go-to testing platform. 

Not only did Abbott's test produce positive results in as little as five minutes, and negative results in 13 minutes, but it used the same portable, point-of-care systems used for testing more common illnesses like strep and flu. On March 27, Gottlieb took to Twitter heralding the Abbott test as a potential "game changer" for ramping up the nation's COVID-19 testing capacity.

Less than a month later, however, FDA issued a letter formally amending the instructions for using Abbott's ID Now amid accuracy concerns. 

Gottlieb warned May 10 in an earlier Face the Nation appearance that the White House is using an Abbott platform that delivers false negative results. "There's machines that are more accurate than that Abbott machine, like the GeneXpert. They take a little longer to perform the test. The reason why the White House prefers the Abbott machine is it gives a result in five to 15 minutes. GeneXpert takes about 45 minutes," Gottlieb said.   

Just days later, on May 14, FDA issued an alert on the Abbott rapid point-of-care coronavirus test after a study by researchers at NYU Langone Health became the latest to link the test to a higher rate of false negatives than alternative diagnostics, including Cepheid's GeneXpert.

Nonetheless, the White House kept using Abbott's ID Now test for those coming in contact with Trump, and for the president's own testing. Gottlieb said that in a setting like the West Wing when testing people who are asymptomatic "you want a very sensitive test."

"The Cepheid GeneXpert probably would be more fit to purpose. But, frankly, you'd need double layers of testing," Gottlieb said. "You'd probably want to test people before they depart for the White House and then test them again when they arrive. And even that wouldn't be 100%, but it would get you closer."

Concerns about the testing machines were raised to the White House at various points, according to Gottlieb. "I think the White House physician weighed in on that. I don't know who else weighed in on that, but I think they need to reassess those protocols," he added.

Gottlieb noted that in addition to Abbott's ID Now the White House is using the company's BinaxNOW Ag Card rapid antigen test, which delivers results in 15 minutes and was granted an EUA on Aug. 26.

"Using that to screen an asymptomatic population to try to detect virus, you might only have 50% sensitivity; perhaps a little bit better than that. But you're going to let through some people who are infected," Gottlieb warned.