FDA probes accuracy issue with Abbott’s rapid virus test
WASHINGTON — Federal health officials are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the White House. The Food and Drug Administration said late Thursday it is investigating preliminary data suggesting Abbott Laboratories’ 15-minute test can miss COVID-19 cases, falsely clearing patients of infection. The warning came one day after researchers at New York University reported results suggesting Abbott’s test can miss up to half the infections caught by a rival test made by Cepheid. The researchers found that Abbott’s test, run on the company’s portable ID NOW system, missed one-third of the infections caught by Cepheid’s test when swabs were stored in liquid used to transport laboratory samples. The FDA first cleared Abbott’s test in late March under emergency powers used to quickly accelerate the review of tests and treatments during a public health crisis.
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