SAN DIEGO, CA., July 29, 2024 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex® Plus COVID-19 and Flu A/B Home Test has been authorized for emergency use by the U.S. Food and Drug Administration.
The new Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.
This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first six (6) days of symptom onset when tested at least twice over three days and within at least 48 hours between tests.
“With symptoms often being similar for COVID-19 and Flu A/B, our new 3-in-1 test offers people the ability to quickly determine which virus is causing those symptoms from the comfort of their home,” said Michael Lynch, VP of Sales and Marketing. “ACON is proud of the success of our Flowflex COVID-19 Antigen Home Test, which has earned the confidence of consumers and become America’s #1 home test kit¹. The Flowflex Plus COVID-19 and Flu A/B Home Test is the next step in our continuing mission to make home testing easy, reliable, and affordable.”
Flowflex Plus COVID-19 and Flu A/B Home Tests will be available starting this fall at major retailers. A list of authorized distributors and retail partners can be found at www.flowflexcovid.com.
¹ SOURCE: Circana Retail Sales Data (Units sold)
About ACON Laboratories
Contact: Rachel Stafford
RStafford@aconlabs.com