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Phase Scientific Gets FDA Emergency Use Authorization for At-Home SARS-CoV-2 Antigen Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a nonprescription, at-home version of Phase Scientific International's SARS-CoV-2 antigen test.

The Indicaid COVID-19 Rapid Antigen At-Home Test is a lateral flow immunoassay designed to detect SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens in individuals with or without COVID-19 symptoms. Samples may be self-collected by individuals after 14 years and older or adult-collected in individuals aged 2 years and older, according to the authorization.

In mid-2021, Hong Kong-based Phase received EUA from the FDA for its Indicaid COVID-19 Rapid Antigen Test, which uses anterior nasal swab specimens collected by a healthcare provider or self-collected under supervision.