Skip to main content
Premium Trial:

Request an Annual Quote

Acon Laboratories Gains FDA EUA for Point-of-Care COVID-19 Antigen Test

NEW YORK – The US Food and Drug Administration said on Thursday it had granted Emergency Use Authorization this month to Acon Laboratories for its nasal swab-based point-of-care Flowflex COVID-19 Antigen Rapid Test.

The San Diego-based firm's healthcare provider-use lateral flow assay provides qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens, the FDA said on its website. It is authorized for use in people who developed COVID-19 symptoms within the prior seven days when tested at least twice over three days with at least 48 hours between tests and is authorized for use in people without symptoms when tested at least three times over five days with at least 48 hours between tests.

Acon also secured an EUA in October 2021 for its over-the-counter Flowflex COVID-19 Antigen Home Test, which uses self-collected anterior nasal swab specimens from individuals aged 14 years and older or adult-collected specimens from individuals aged 2 and older.