Acon Laboratories Gets FDA Emergency Use Authorization for OTC COVID, Flu Test

Original from: 360dx

The US Food and Drug Administration recently granted Emergency Use Authorization for an over-the-counter combination COVID-19 and influenza test developed by Acon Laboratories.

The Flowflex Plus COVID-19 and Flu A/B Home Test is designed for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in anterior nasal swab specimens collected at home. The lateral flow immunoassay is only authorized for use by individuals with suspected COVID-19 infection within the first six 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 marks the latest in a series of authorizations that San Diego-based Acon has received for its COVID-19 tests, which include the Flowflex Plus COVID-19 Home Test and the Flowflex COVID-19 Antigen Home Test.

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Source: Acon Laboratories Gets FDA Emergency Use Authorization for OTC COVID, Flu Test