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FDA Grants Emergency Use Authorization for At-Home Version of Wondfo Biotech COVID, Flu Assay

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a home-use version of a combination COVID-19 and influenza immunoassay developed by Chinese diagnostics firm Wondfo Biotech.

The WellLife COVID-19/Influenza A&B Home Test is designed to detect and differentiate influenza A, influenza B, and SARS-CoV-2 protein antigens in self-collected or adult-collected anterior nasal swab specimens. The lateral flow immunoassay is authorized for use only within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests, according to the FDA.

The EUA was issued to Wondfo's San Diego-based subsidiary Wondfo USA. In a statement, Wondfo USA said  the test was developed as part of the National Institutes of Health Rapid Acceleration of Diagnostics Tech's Independent Test Assessment Program. 

It added that it has established a manufacturing facility in San Diego.

Last month, Wondfo USA received EUA from the FDA for a point-of-care version of the COVID-19/influenza test.