FDA probes accuracy issue with Abbott's rapid virus test

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 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. Last month Abbott 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. The FDA said in a statement it is reviewing the data with Abbott and working on a letter to health care providers about potential accuracy issues. The agency said physicians may need to confirm the results of a negative Abbott test if patients have signs and symptoms of the virus.