FDA Commissioner Talks About Abbott Labs Rapid Test Issue
CHICAGO (CBS)-- The Commissioner of the Food and Drug Administration spoke out after reports that Abbott Labs knew COVID-19 rapid tests may give inaccurate results.
A new NYU study suggests the test frequently misses cases of the virus giving false negative results. Dr. Steven Han said testing has always been evaluated and revised, but the study may not give the full picture.
"There are some data to suggest that there may be inaccuracies and false negatives with the test," Han said. "However, there are many users who have contacted us and have not had this problem. The FDA is digging into it. And we're working with Abbott to actually look at what data are available to get the most up to date and accurate information about the test performance."
Abbott maintains its rapid tests can give results with great accuracy within just 13 minutes. The lab says, in the study, it was used in a way it wasn't designed for.
The company, which is based in suburban North Chicago, plants to clarify its guidelines and continue to refine the test. The FDA gave it emergency authorization in late March.
Han sais if a test comes back negative, it might be worth getting a second test done to confirm the original results.