The US drug regulator has warned the coronavirus test being used by the White House could be missing significant numbers of patients, after a study found it could be giving false negative results in almost half of cases.
The Food and Drug Administration on Thursday night warned the test provided by Abbott Laboratories could be returning inaccurate results, just days after members of Donald Trump’s inner circle tested positive for Covid-19.
The FDA said “early data” had shown Abbott’s ID Now test might be returning false negative results, adding that officials were investigating why that might be the case.
Tim Stenzel, director of the office of in vitro diagnostics at the FDA’s Center for Devices and Radiological Health, said: “We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue.
“We will continue to study the data available and are working with the company to create additional mechanisms for studying the test,” he said.
The warning came a day after it emerged that a report from New York University had found Abbott’s test, designed to provide a prompt result, missed at least a third of positive cases detected with a rival test. The report, which was posted on BioRxiv, where scientists post work before being peer-reviewed, found the Abbott test missed as many as 48 per cent of cases when using dry nasal swabs, as currently recommended.
The NYU findings were first reported by Bloomberg.
The FDA said it had received 15 reports from manufacturers, healthcare providers and patients about users receiving false negative results. The agency said it was working on a letter warning users to get a second test if they had symptoms of coronavirus but had found to be negative according to the Abbott test.
The warning comes days after two senior officials close to the president tested positive for the disease. Donald Trump’s personal valet and Katie Miller, communications director for vice-president Mike Pence, both tested positive for coronavirus last week.
Since then White House officials have been told they must wear face masks to work. Meanwhile, three senior scientists — Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases, Stephen Hahn, the FDA commissioner, and Robert Redfield, head of the Centers for Disease Control and Prevention — have begun modified forms of self-quarantine.
Kayleigh McEnany, the president’s press secretary, on Thursday insisted there was no plan for Nancy Pelosi, the Democratic speaker of the House of Representatives, to take the role of president should both Mr Trump and Mr Pence fall ill.
“That’s not even something that we’re addressing,” she told reporters. “We’re keeping the president healthy. We’re keeping the vice-president healthy. And you know they’re healthy at this moment, and they’ll continue to be.”