FAQ: ACON Laboratories' FDA-Cleared Flowflex® Plus RSV + Flu A/B + COVID Home Test
Summary
ACON Laboratories has received FDA clearance for the Flowflex® Plus RSV + Flu A/B + COVID Home Test, the first 4-in-1 respiratory home test that simultaneously detects RSV, influenza A, influenza B, and SARS-CoV-2. This breakthrough enables consumers to identify specific respiratory infections at home, supporting early treatment decisions and offering peace of mind, especially for parents of young children and at-risk populations.
What is the Flowflex® Plus RSV + Flu A/B + COVID Home Test?
It is an over-the-counter rapid antigen test that simultaneously detects and differentiates respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 (COVID) protein antigens from self-collected nasal swab specimens at home.
Why is this test considered groundbreaking?
It is the first FDA-cleared 4-in-1 respiratory home test, the first FDA-cleared RSV home test, and the first respiratory infection home test cleared for children aged 6-23 months when administered by an adult using ACON’s proprietary nasal swab guard.
Who can use this home test?
The test is authorized for non-prescription home use by consumers, including children aged 6-23 months when administered by an adult using ACON’s nasal swab guard, making it particularly valuable for parents, the elderly, immune-compromised individuals, and those in contact with at-risk populations.
How does the test work?
It is a lateral flow immunoassay that uses self-collected anterior nares nasal swab specimens to rapidly and qualitatively detect and differentiate RSV, Flu A/B, and COVID protein antigens in one test.
When and where will the test be available?
The test will be widely available at major retailers later this year and is manufactured domestically at ACON’s facility in San Diego, CA. A list of authorized distributors and retail partners can be found at www.flowflexcovid.com.
What are the key benefits of this 4-in-1 test?
It enables consumers to identify which specific respiratory infection they have when symptoms are similar, supporting early treatment decisions that can lead to better outcomes and providing peace of mind for families and at-risk individuals.
Who manufactures this test and what is their track record?
ACON Laboratories, Inc., a leading global medical device manufacturer, produces the test, and Flowflex continues to be America’s #1 home test brand according to Circana Retail Sales Data.
What regulatory approval has this test received?
The Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for over-the-counter home use.
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