Rapid Host-Response Assay Gains FDA Clearance to Help Distinguish Bacterial and Viral Infections

Clinicians may need to begin treatment before traditional diagnostic methods, which can take hours or days, provide definitive results. A newly cleared host-response blood test now delivers results in as little as 15 minutes to help distinguish bacterial from viral infections in adults and children.

Beckman Coulter Diagnostics (Brea, CA, USA) has received U.S. Food and Drug Administration (FDA) clearance for the Access MeMed BV assay, a rapid blood test for adult and pediatric patients. The assay is available on the DxI 9000 and Access 2 immunoassay analyzers already installed in hospital laboratories nationwide. On the DxI 9000 Analyzer, results can be available in as little as 15 minutes, allowing laboratories to provide timely information to support treatment decisions without requiring new instrumentation or changes to existing workflows.

Developed in collaboration with MeMed, the automated host-response assay measures the body’s immune response to infection by analyzing three proteins: TRAIL, IP-10, and CRP. The test uses serum or plasma from patients with suspected acute infection and symptoms lasting fewer than seven days and generates a score indicating the likelihood of bacterial infection. It is intended to be used alongside clinical assessment and other laboratory findings for patients evaluated in emergency departments or urgent care settings, as well as for samples collected at hospital admission.

Clinical studies and real-world evidence have demonstrated the potential of MeMed BV to support treatment decisions and antibiotic use. Physicians have reported that test results support or change clinical decision-making in a significant majority of cases, while validation studies have shown strong performance in helping exclude bacterial infection.

Published health-economic modeling in patients with community-acquired pneumonia estimated approximately 1,129 fewer antibiotic days per 1,000 patients when MeMed BV was added to the diagnostic standard of care. Separately, real-world data from Tampa General Hospital showed an estimated USD 1,790 reduction in cost per patient, primarily from avoiding unnecessary admissions among patients considered unlikely to have bacterial sepsis. The Access MeMed BV assay received CE marking in April 2026.

“By delivering bacterial and viral differentiation in as little as 15 minutes on the DxI 9000 Analyzer, we're helping give clinicians greater confidence to make timely, appropriate treatment decisions. That added confidence can be particularly valuable when deciding whether antibiotics are appropriate, helping support responsible antibiotic use while ensuring patients, including children as young as 90 days old, who need antibiotics receive the care they need,” said Melissa Naiman, Senior Director, Medical & Scientific Affairs, Acute Care at Beckman Coulter Diagnostics.