FDA Warns Rapid Coronavirus Tests May Give False Negatives

The FDA announced late Thursday it was investigating preliminary data suggesting the rapid Abbott test can miss COVID-19 cases. Abbott has rejected the findings.

President Donald Trump expressed no concerns Friday about a rapid coronavirus test that the White House has been relying on to ensure his safety, despite new data suggesting the test may return an inordinate share of false negatives.

What We Know:

  • Trump expressed his confidence in the test from Abbott Laboratories after a preliminary study by New York University researchers reported problems with it. Trump and his deputies have promoted the 15-minute test as a “game changer” and have been using it for weeks now to try to keep the White House complex safe.
  • “Abbott is a great test; it’s a very quick test,” Trump said at a Rose Garden event to highlight his administrations efforts to develop a vaccine for the virus. “And it can always be very rapidly double checked.”

“We’ve got to get to the bottom of it, but we still have confidence in the test, or we wouldn’t have it on the market.” – Alex Azar; Health and Human Services Secretary

 

  • Azar described the FDA warning as a routine announcement that comes after medical manufacturers submit any type of negative information about their product.
  • On Friday, FDA Commissioner Steve Hahn said that if a person is suspected of having the disease caused by the coronavirus, “it might be worth, if the test is negative, getting a second confirmatory test. That’s what our guidance is about.“
  • White House Press Secretary Kayleigh McEnany said she had discussed the issue with Hahn and suggested some of the high false negative results may have been the result of “user error.” McEnany also cited the president’s daily test as a reason he chooses not to wear a mask.
  • The FDA warning came a day after New York University researchers reported results suggesting Abbott’s test can miss up to half the infections caught by a rival test made by Cepheid. The research has not been peer-reviewed or published in a medical journal and was based on about 100 patients.
  • The researchers called the test’s performance “unacceptable,” due to the risk of falsely clearing patients who could spread the infection to others. They acknowledged shortcomings of the study, including the time needed to transport patient samples to the device for processing.
  • “ID NOW is intended to be used near the patient with a direct swab test method,” the Abbot company said in a statement. Last month Abbot changed the instructions for its test to explicitly warn against putting patient samples in transport chemicals. The update came after researchers at the Cleveland Clinic reported a 15% false negative rate for samples stored in the chemicals.
  • Federal contracting data show the White House spent $140,666 on the Abbot rapid test kits in April. The Department of Health and Human Services also paid more than $27.3 million last month for the problematic Abbott tests.

Former FDA Commissioner Scott Gottlieb similarly warned about the accuracy of Abbot’s tests in an interview with CBS NEWS, but dubbed the antigen test, like the one developed by Quidel Corporation as a “real game changer.”

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CoronavirusPolitics

Dominique Browder is a Digital Intern at UnmutedCo.

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