NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization to Acon Laboratories' Flowflex COVID-19 Home Test, an over-the-counter antigen test for SARS-CoV-2.
The nonprescription lateral flow test is designed to detect the SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab specimens from symptomatic or asymptomatic individuals aged 14 years and older. It can also be used with adult-collected specimens from individuals aged 2 years and older.
Test results can be visually interpreted within 15 minutes.
The FDA said that this EUA should significantly increase the availability of rapid, at-home tests for consumers and is expected to double rapid at-home testing capacity in the US over the next several weeks. By year-end, Acon plans to produce more than 100 million tests per month, with production rising to 200 million per month by February 2022.
In late 2020, San Diego-based Acon received EUA from the FDA for a SARS-CoV-2 antibody test.