The US drug regulator has warned that the coronavirus test used by the White House could miss a significant number of patients, after a study found that it could give false negative results in almost half of the cases.
On Thursday evening, the Food and Drug Administration warned that the test provided by Abbott Laboratories could return inaccurate results, just days after members of Donald Trump’s inner circle tested positive for Covid-19.
The FDA said “the first data” had shown that Abbott’s ID test could return false negative results, adding that authorities were investigating why this might be the case.
Tim Stenzel, director of the in vitro diagnostics office at the FDA’s Center for Devices and Radiological Health, said, “We are still evaluating information on the inaccurate results and are in direct communication with Abbott about this important issue.
“We will continue to study the available data 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 New York University report had found the Abbott test, designed to provide a rapid result, missed at least a third of the positive cases detected with a rival test. The report, which was published on BioRxiv, where scientists publish work before being peer-reviewed, found that Abbott’s test had missed up to 48% of cases when using swabs dry nasals, as currently recommended.
NYU’s results were first reported by Bloomberg.
The FDA said it has received 15 reports from manufacturers, healthcare providers, and patients regarding users receiving false negative results. The agency said it was working on a letter warning users to take a second test if they had symptoms of coronavirus, but had tested negative according to the Abbott test.
The warning comes days after two senior officials close to the president tested positive for the disease. Personal valet Donald Trump and Katie Miller, vice president Mike Pence’s director of communications, both tested positive for coronavirus last week.
Since then, White House officials have been told they have to wear face masks to work. Meanwhile, three senior scientists – Anthony Fauci, head of the United States National Institute of Allergies and Infectious Diseases, Stephen Hahn, the FDA Commissioner, and Robert Redfield, head of the Centers for Disease Control and Prevention – began to modify forms of self-quarantine.
Kayleigh McEnany, the president’s press secretary, insisted on Thursday that the Democratic Speaker of the House of Representatives Nancy Pelosi was not expected to assume the role of president in the event of Trump and Pence’s illness .
“It’s not even something we’re talking about,” she told reporters. “We keep the president healthy. We keep the Vice President in good health. And you know they are healthy right now, and they will continue to be. “