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

Contagion Live 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.