FDA Warns of False Negatives from Abbott’s COVID Test

May 18, 2020

The FDA has warned that Abbott’s ID NOW point-of-care COVID-19 diagnostic test may give inaccurate results.

The agency said it has received 15 adverse event reports, suggesting some users are receiving false-negative results.

The FDA said the inaccuracies may be linked to the types of swabs being used or the material used to transport the patient’s specimen.

The diagnostic may still be used as it can correctly identify patients with the virus, but negative results may need to be confirmed with a high-sensitivity molecular test, the agency said.

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