FDA Clears First At-Home 4-in-1 Respiratory Test for Infants and Adults
Key Insights
ACON Laboratories (search) launched the Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test (search), marking the first FDA-cleared home diagnostic capable of detecting four major respiratory infections with a single nasal swab.
The test represents a breakthrough for pediatric care as the first respiratory home test cleared for use in children as young as six months, addressing critical RSV (search) detection needs.
Early identification capabilities are particularly significant since RSV (search) is the leading cause of hospitalization in young children according to the CDC (search).
ACON Laboratories (search) announced the retail availability of the Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test (search), marking a significant advancement in at-home respiratory diagnostics for families. The test represents the first FDA-cleared home diagnostic that allows consumers to identify four major respiratory infections—RSV (search), influenza A (search), influenza B (search), and COVID-19 (search)—using a single nasal swab.
Pediatric Testing Breakthrough
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 makes it the first respiratory home test cleared by the FDA for use in such young children, addressing a critical gap in RSV (search) detection for the most vulnerable population.
The pediatric application is particularly significant because RSV (search) is the leading cause of hospitalization in young children, as identified by the Centers for Disease Control and Prevention. Early identification of RSV in infants can help parents and caregivers make more informed decisions about monitoring symptoms and seeking medical care.
Clinical Impact and Decision-Making
"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 (search). "This test gives people clarity sooner, and in the comfort of their own home."
For families managing symptoms such as fever, cough, congestion, or wheezing, the ability to distinguish between RSV (search), flu, and COVID-19 (search) 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.
Test Specifications and Availability
The Flowflex Plus RSV (search) + Flu A/B + COVID Home Test is an over-the-counter rapid antigen test that simultaneously detects all four respiratory pathogens using a simple nasal swab. Results are available quickly and can help families decide whether to seek medical care, isolate, or take additional precautions, particularly when caring for infants, older adults, or individuals with compromised immune systems.
The launch reflects the broader shift toward at-home care and consumer-driven diagnostics. Flowflex is already ranked as America's #1 home test brand according to Circana Retail Sales Data, and the introduction of this 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 (search) is now available nationwide at major retailers including CVS, Walgreens, Albertsons, and others.