FDA Clears First 4-in-1 Home Test for RSV, Flu, and COVID-19, Including for Young Children

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 the first over-the-counter rapid antigen test that allows consumers to test for four different respiratory infections simultaneously from their homes. This lateral flow immunoassay is designed for the rapid, simultaneous qualitative detection and differentiation of respiratory syncytial virus, influenza A, influenza B, and SARS-CoV-2 protein antigens. The test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens and will be manufactured domestically in ACON's San Diego facility.

This clearance represents multiple significant milestones in home diagnostic testing. It is the first 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. Michael Lynch, VP of Sales & Marketing at ACON, emphasized the importance of this development, stating that the product demonstrates the company's commitment to enabling consumers to take charge of their own health. Lynch explained that symptoms of respiratory infections can be similar, so knowing which infection you have is important for making early treatment decisions, which can lead to better outcomes.

The test holds particular significance for vulnerable populations, including parents of young children, the elderly, and immunocompromised individuals. Lynch noted that the company expects the Flowflex 4-in-1 home test will bring peace of mind to parents of young children as well as those in contact with at-risk populations. Flowflex continues to maintain its position as America's leading home test brand according to Circana Retail Sales Data, and the new Flowflex Plus RSV + Flu A/B + COVID Home Test will be widely available at major retailers later this year. Additional information about authorized distributors and retail partners can be found at https://www.flowflexcovid.com.

The introduction of this comprehensive home testing solution addresses a critical need in public health management by providing consumers with accessible tools to identify specific respiratory infections quickly. This capability is especially important during seasonal respiratory illness periods when multiple viruses circulate simultaneously. The ability to distinguish between RSV, influenza A, influenza B, and COVID-19 from a single test could potentially reduce unnecessary medical visits, enable more targeted treatment approaches, and help individuals make informed decisions about isolation and care. The clearance for use in young children represents a particularly important advancement, as this age group has historically had limited options for at-home respiratory testing. The domestic manufacturing of the test in San Diego also supports supply chain reliability for these critical diagnostic tools.