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FDA Gives Emergency Use Authorization to Wondfo Biotech Point-of-Care COVID, Flu Assay

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

WellLife COVID-19/Influenza A&B Test is designed to simultaneously detect and differentiate influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens. The lateral flow immunochromatographic assay is authorized for use with samples taken 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 assay may be performed by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, as well as at point-of-are settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.

The EUA was issued to Wondfo's San Diego-based subsidiary.