FDA clears first at-home test to detect RSV, flu, and COVID-19 in infants as young as 6 months

ACON Laboratories, Inc. announced the retail availability of the first FDA–cleared home test that allows families to identify 4 common respiratory infections—respiratory syncytial virus (RSV), influenza A, influenza B, and COVID-19—using a single test in adults and children as young as 6 months. The Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test is an over-the-counter rapid antigen test designed to support earlier identification of respiratory illness symptoms at home.^1,2

The clearance is notable due to RSV being the leading cause of hospitalization among young children, according to the US Centers for Disease Control and Prevention. Until now, no FDA-cleared home test has been authorized for RSV detection in infants. The Flowflex Plus 4-in-1 test is cleared for use in children aged 6 months and older when administered by an adult using ACON’s proprietary nasal swab guard.

The test is intended to help families distinguish between viral respiratory infections that often present with similar symptoms, including fever, cough, congestion, and wheezing. Differentiating among RSV, influenza, and COVID-19 may influence decisions related to monitoring at home, seeking medical care, isolating, or taking additional precautions, particularly in households with infants, older adults, or individuals who are immunocompromised.

“Respiratory symptoms often look the same, but the decisions families need to make can be very different,” said Michael Lynch, vice president of sales & marketing at ACON Laboratories. “This test gives people clarity sooner, and in the comfort of their own home.”

The Flowflex Plus RSV + Flu A/B + COVID Home Test uses a single nasal swab specimen to simultaneously detect antigens associated with RSV, influenza A, influenza B, and SARS-CoV-2. Results are available within minutes, allowing for rapid interpretation without the need for laboratory processing or a clinical visit. The company noted that the test is designed for ease of use by consumers and caregivers, including parents administering the test to young children.

Home-based diagnostic testing has expanded significantly in recent years, particularly during the COVID-19 pandemic, as consumers have sought more accessible and timely health information. According to ACON Laboratories, Flowflex is already widely used in the US market, and the addition of a multi-pathogen respiratory panel represents an extension of at-home testing beyond single-disease detection.

The company positioned the new test as part of a broader shift toward decentralized care, in which patients and families can obtain actionable health information outside of traditional clinical settings. While home testing does not replace clinical evaluation, early identification of respiratory viruses may support more informed discussions with pediatricians and other clinicians, particularly during peak respiratory virus seasons.

The Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test is now available nationwide at major retail pharmacies and grocery chains, including CVS, Walgreens, and Albertsons, as well as other retailers. The test is sold over the counter without a prescription.

ACON Laboratories stated that additional product information and updates are available through the Flowflex website.

Reference

1. ACON Laboratories. Flowflex Launches First FDA-Cleared 4-in-1 Home Test Detecting RSV, Flu A/B and COVID for Ages 6 Months+. PR Newswire. January 23, 2026. Accessed January 23, 2026. https://www.prnewswire.com/news-releases/flowflex-launches-first-fda-cleared-4-in-1-home-test-detecting-rsv-flu-ab-and-covid-for-ages-6-months-302668750.html
2. ACON Laboratories. About. ACON Laboratories. 2026. Accessed January 23, 2026. https://www.aconlabs.com/about/