NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Mologic's over-the-counter SARS-CoV-2 antigen test.
The COVI-Go SARS-CoV-2 Ag Self-Test is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen using self-collected anterior nasal specimens. Results are provided within 20 minutes, the FDA said.
The lateral flow chromatographic immunoassay is authorized for use by symptomatic individuals within the first five 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 asymptomatic individuals when tested at least three times over five days with at least 48 hours between tests.
In mid-2021, UK-based Mologic was acquired by a group of investors led by the Soros Economic Development Fund with support from the Bill & Melinda Gates Foundation, becoming a part of social enterprise Global Access Health.