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FDA Clears First 4-in-1 Home Test for RSV, Flu & COVID

ACON Laboratories receives FDA clearance for first 4-in-1 home test detecting RSV, Flu A/B & COVID simultaneously. Available at major retailers via www.flowflexcovid.com.

This development matters because it fundamentally changes how people can manage respiratory health at home. For the first time, consumers can quickly distinguish between four major respiratory illnesses—RSV, influenza A, influenza B, and COVID-19—without visiting a healthcare facility. This is particularly crucial during respiratory season when these viruses often circulate simultaneously with overlapping symptoms. Early identification enables faster treatment decisions, potentially reducing severe outcomes and transmission risks. The test's authorization for children as young as 6 months addresses a critical gap in pediatric care, giving parents immediate answers about their child's respiratory symptoms. For vulnerable populations including the elderly and immunocompromised, this test provides accessible diagnostic capabilities that could significantly impact treatment timing and outcomes.