FDA Clears First At-Home 4-in-1 Respiratory Test Detecting RSV, Influenza A/B, and COVID-19 in Infants, Adults

ACON Laboratories announced the retail availability of the first US Food and Drug Administration–cleared at-home test capable of simultaneously detecting respiratory syncytial virus (RSV), influenza A, influenza B, and COVID-19 using a single nasal swab. The over-the-counter test is cleared for use in adults and in children as young as 6 months, when administered by an adult, according to the company.

The test is designed to help families identify the likely cause of common respiratory symptoms such as fever, cough, congestion, and wheezing without leaving home. The inclusion of RSV detection in infants is notable, as RSV remains the leading cause of hospitalization among young children, based on data from the US Centers for Disease Control and Prevention.

Pediatric clearance and intended use

According to ACON, the test is the first FDA-cleared home respiratory panel authorized for use in children aged 6 months and older. Pediatric testing is enabled through use of a proprietary nasal swab guard intended to support appropriate sample collection when administered by a caregiver.

The company stated that distinguishing among RSV, influenza, and COVID-19 may help caregivers determine next steps, including whether to seek medical evaluation, initiate isolation measures, or take additional precautions for household contacts who may be at higher risk for complications, such as older adults or individuals who are immunocompromised.

Test characteristics

The 4-in-1 home test is a rapid antigen assay that detects RSV, influenza A, influenza B, and SARS-CoV-2 from a single nasal specimen. Results are available within minutes, according to the manufacturer. The test is intended for symptomatic individuals and is available without a prescription.

While the announcement emphasized consumer-facing use, at-home respiratory testing may also have implications for outpatient clinical workflows by supporting earlier symptom triage and potentially reducing unnecessary in-person visits, particularly during peak respiratory virus seasons.

Broader context of at-home respiratory testing

Home-based diagnostic testing has expanded substantially since the COVID-19 pandemic, with increasing consumer familiarity and acceptance of self-testing for infectious diseases. ACON noted that the introduction of a multi-pathogen respiratory test reflects ongoing demand for accessible diagnostic tools that provide rapid results outside traditional care settings.

The company did not disclose pricing or distribution details in the announcement but stated that the test is now available at retail locations.