The U.S. Food & Drug Administration has granted 510(k) clearance to ACON Laboratories, Inc. for its Flowflex® Plus RSV + Flu A/B + COVID Home Test, creating a new category in consumer diagnostics. This over-the-counter rapid antigen test allows individuals to test simultaneously for respiratory syncytial virus, influenza A, influenza B, and SARS-CoV-2 from their homes using a single nasal swab specimen. The clearance represents multiple industry firsts: it is the initial FDA-cleared 4-in-1 respiratory home test, the first FDA-cleared RSV home test, and notably, 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.
The test's authorization addresses a critical need in public health management, as symptoms of these respiratory infections often overlap, making accurate identification challenging without professional testing. Michael Lynch, VP of Sales & Marketing at ACON, emphasized that knowing which infection is present enables early treatment decisions that can lead to better health outcomes. The test is manufactured domestically at ACON's San Diego facility and will be available through major retailers later this year, with distribution information accessible at https://www.flowflexcovid.com.
This development holds particular significance for vulnerable populations, including parents of young children, elderly individuals, and those with compromised immune systems. Lynch noted that the test provides peace of mind for caregivers and those in contact with at-risk groups by offering rapid, accessible diagnostic information. The clearance reinforces Flowflex's position as America's leading home test brand according to Circana Retail Sales Data, while expanding consumer access to comprehensive respiratory testing previously available only in clinical settings.
The test's design as a lateral flow immunoassay provides qualitative detection and differentiation of the four viral protein antigens through self-collected anterior nares nasal swab specimens. This technological advancement in home testing represents a shift toward consumer empowerment in health management, allowing individuals to make informed decisions about isolation, treatment, and medical consultation based on specific infection identification. The simultaneous testing capability reduces the need for multiple tests and streamlines the diagnostic process during respiratory illness seasons when multiple viruses circulate concurrently.
