FDA clears 15-minute blood test that tells bacterial from viral infections

The FDA has cleared Access MeMed BV, a rapid blood test that can distinguish between bacterial and viral infections in as little as 15 minutes. Developed by MeMed and distributed by Beckman Coulter Diagnostics, the test is approved for use in adults and children as young as 90 days old. Crucially, it runs on immunoassay analyzers already installed in hospitals and urgent care centers — meaning no new equipment or workflow changes are needed.

The test works by measuring three immune-response proteins in blood and running the results through a machine-learning algorithm to generate a probability score for bacterial vs. viral infection. Its clearance comes amid rising concern over antimicrobial resistance, with federal data showing a steep increase in drug-resistant infections and deaths in the U.S.

By the Numbers:

• 15 minutes to generate results
• 86% of cases: physicians said the test aided in patient management
• 20.5% reduction in ED referrals in one study
• 90% sensitivity and 92.8% specificity for bacterial infections
• 98.8% negative predictive value — strong confidence when ruling out bacterial infection

Why it matters: Antibiotic overuse often stems from diagnostic uncertainty. This test gives clinicians objective, real-time data to decide whether antibiotics are truly needed — a meaningful step in the fight against antimicrobial resistance, particularly in emergency and hospital settings.