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Abbott Gets FDA Emergency Use Authorization for Point-of-Care COVID-19 Test

NEW YORK — The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.

The test runs on the company's ID Now system, which uses isothermal nucleic acid amplification for the qualitative detection of infectious diseases and is designed to detect SARS-CoV-2 nucleic acid in direct anterior nasal or nasopharyngeal swab specimens within the first seven days of symptom onset.

The test is authorized for use by labs CLIA certified to perform high-, moderate-, or waived-complexity tests, according to the FDA. It is also authorized for use at the point of care in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

In 2020, Abbott Park, Illinois-based Abbott received EUA from the FDA for an earlier version of the ID Now COVID-19 test.