NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Nano-Ditech's over-the-counter Nano-Check COVID-19 Antigen At-Home Test.
The lateral flow assay is designed for the at-home qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab specimens. It is authorized for use by individuals with symptoms of COVID-19 within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests. It is also authorized for use by individuals when tested at least three times over five days with at least 48 hours between tests.
In late 2021, Cranbury, New Jersey-based Nano-Ditech — a subsidiary of South Korea's Precision Biosensor — received EUA from the FDA for a prescription version of the test.