News|Articles|January 26, 2026

FDA Clears First At-Home Diagnostic for RSV, Influenza, and COVID-19 in Adults, Young Infants

The federal agency gave the nod for Acon Laboratories’ Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test that can detect all those respiratory viruses in a single test, which is indicated for use in both adults and children as young as 6 months.

Acon Laboratories announced the retail availability of the Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test, marking a significant advancement in at-home respiratory diagnostics for families. The test is the first FDA-cleared home diagnostic that allows consumers to identify 4 major respiratory infections—RSV, influenza A, influenza B, and COVID-19—using a single nasal swab. "Respiratory symptoms often look the same, but the decisions families need to make can be very different," Michael Lynch, vice president of Sales & Marketing at ACON Laboratories, said in a statement. "This test gives people clarity sooner, and in the comfort of their own home."

A key differentiator of the Flowflex Plus 4-in-1 test is its clearance for use in children as young as six months when administered by an adult using Acon’s proprietary nasal swab guard. This is especially important for RSV, which the Centers for Disease Control and Prevention identifies as the leading cause of hospitalization in young children. Early identification of RSV in infants can help parents and caregivers make more informed decisions about monitoring symptoms and seeking medical care.

What You Need to Know

The Flowflex Plus 4-in-1 is the first FDA-cleared home test to detect RSV, flu A, flu B, and COVID-19 in a single test.

It is the first respiratory home test cleared for use in children as young as six months, addressing a critical gap in RSV detection.

The launch underscores the growing role of at-home diagnostics in helping families quickly manage respiratory illnesses without immediate clinical visits.

For families managing symptoms such as fever, cough, congestion, or wheezing, the ability to distinguish between RSV, flu, and COVID-19 at home can provide clarity during a time when respiratory illnesses often overlap. The test supports faster decision-making around treatment options, isolation, and follow-up care, reducing uncertainty and potentially easing strain on healthcare settings.

The launch also reflects the broader shift toward at-home care and consumer-driven diagnostics. Flowflex is already the top-ranked home test brand in the United States, and the introduction of a multi-pathogen test strengthens Acon’s position in the rapidly expanding home diagnostics market.

The Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test is now available nationwide at major retailers including CVS, Walgreens, Albertsons, and others. Additional product details and updates are available at Flowflex’s website.

Reference
 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

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