FDA Clears Rapid Test Distinguishing Bacterial, Viral Infections

The 15-minute blood test uses three immune-response proteins and a machine-learning algorithm to help clinicians decide on antibiotic use.

Updated on Nov. 3, 2026 in Life Sciences

FDA Clears Rapid Test Distinguishing Bacterial, Viral Infections

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Do you trust doctors to decide when antibiotics are needed without extra tests?

The FDA cleared Access MeMed BV's rapid blood test, which distinguishes bacterial from viral infections and returns results in 15 minutes. Beckman Coulter Diagnostics will distribute the test and run it on its DxI 9000 and Access 2 analyzers at U.S. medical facilities.

Why it matters

The test is intended to help clinicians reduce unnecessary antibiotic use, a major driver of antibiotic resistance. It arrives as federal data showed a rise in antimicrobial-resistant infections and deaths.

A 2025 physician-reported study of more than 3,000 cases found the test aided patient management in 86% of cases and avoided emergency department referrals 20.5% of the time. In a prior study it showed 90% sensitivity, 92.8% specificity and a 98.8% negative predictive value for bacterial infections.

The players

Beckman Coulter Diagnostics

Beckman Coulter Diagnostics is a major manufacturer of clinical laboratory diagnostic instruments and will distribute and run the test on its equipment.

Access MeMed BV

Access MeMed BV is the company that developed the rapid blood test and received FDA clearance for it.

The details

The test measures three host immune-response proteins in serum or plasma and uses a machine-learning algorithm to produce a single score indicating the probability of a bacterial or viral infection. It is cleared for adults and children as young as 90 days and runs on existing diagnostic equipment installed in hospitals and urgent care centers.

- 2025: A study of more than 3,000 cases reported physician-aided patient management.
- November 3, 2026: FDA clearance was announced for Access MeMed BV.

The Big Picture

Clinicians have long relied on bacterial culture and broad markers that cannot cleanly separate bacterial from viral infection at the bedside. This clearance moves host-response biomarker testing toward routine use on analyzers already installed in hospitals and urgent care centers.

For patients with fever or respiratory symptoms, a faster test could help clinicians decide sooner whether antibiotics are needed. The test is cleared for children as young as 90 days, so its use may extend to infants evaluated for infection.

The takeaway

Ask your clinician whether a test that separates bacterial from viral infection could help avoid unnecessary antibiotics at your next visit. Antibiotics do not treat viral illnesses, so reducing unneeded prescriptions helps limit antibiotic resistance.