The White Home Wager on Abbott’s Speedy Assessments. It Did not Work Out.

The White House Bet on Abbott's Rapid Tests. It Didn't Work Out.

People with no Covid-19 symptoms were among those taking the test for White House reasons, which gave those who had negative results quick access to the president and his advisors.

Dr. Scott Gottlieb, the former FDA commissioner, described these procedures as a misguided attempt at a "zero-fail testing protocol" in an interview on CBS's "Face the Nation" on Sunday, saying officials "didn't take it." Any precautionary measures beyond testing anyone who will come into contact with the President. "

However, according to the product packaging, both Abbott rapid tests are intended for people with Covid-19 symptoms at the onset of their illness. When Abbott passed the F.D.A. the company only made data available to people with symptoms. When used properly, the company said, both tests pass about 95 percent as well as P.C.R. But how well the products work on asymptomatic people remains unclear.

In a statement, Darcy Ross, Abbott's senior director of external communications, said the instructions that came with both products allowed doctors to conduct tests at their own discretion, regardless of whether the recipients had symptoms. "As with all tests given an E.U.A., a health care provider will determine if a person needs a Covid-19 test," she said.

Dr. Krutika Kuppalli, a South Carolina-based infectious disease doctor, said she would not be comfortable doing such tests on healthy patients: "We have no data to show how this test will perform in this population."

Abbott was not required to submit data assessing the performance of a test in asymptomatic populations when obtaining emergency approval from the F.D.A. However, Ms. Ross confirmed that such studies are ongoing, and the company has advised experts that it believes asymptomatic testing is likely to be successful.

On Saturday evening, Andrea Wainer, Abbott's Executive Vice President, Rapid and Molecular Diagnostics, emailed a document entitled "Perspectives on Testing" to several public health experts, including Dr. Ashish Jha, Dean of Brown University School of Public Health, with preliminary information results describing the performance of ID NOW in people with no symptoms. Among an unspecified number of people, the test picked up approximately 88 percent of the infections identified by the P.C.R. Tests, said the company statement. No numbers were reported for BinaxNOW.


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