Rapid Blood Test Tells Bacterial From Viral Infection

The FDA-cleared test gives results in 15 minutes, aiming to reduce unnecessary antibiotic prescribing at U.S. facilities.

Updated on Nov. 3, 2026 in Life Sciences

Rapid Blood Test Tells Bacterial From Viral Infection

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

The FDA has cleared Access MeMed BV, a rapid blood test that helps clinicians tell bacterial from viral infections. The test is cleared for use and is announced as an FDA clearance, with Beckman Coulter Diagnostics set to distribute it and run it on its equipment 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. Its timing follows federal data published one week earlier showing a rise in antimicrobial-resistant infections and deaths.

The test reports 90% sensitivity and 92.8% specificity for bacterial infections in a prior study, with a 98.8% negative predictive value. In a 2025 physician-reported study of more than 3,000 cases, it aided patient management in 86% of cases, though the stub gives no baseline for comparison.

The players

Access MeMed BV

The company behind the rapid bacterial-versus-viral blood test that received FDA clearance.

Beckman Coulter Diagnostics

A diagnostics unit that will distribute the test and run it on its immunoassay analyzers at U.S. medical facilities.

U.S. Food and Drug Administration

The federal agency that cleared the test for use in adults and children as young as 90 days.

The details

The test measures three host immune-response proteins in serum or plasma: tumor necrosis factor-related apoptosis-inducing ligand, interferon-gamma induced protein-10, and C-reactive protein. A machine-learning algorithm combines these measurements into a single score that indicates the probability of a bacterial or viral infection. The test runs on DxI 9000 and Access 2 immunoassay analyzers, existing diagnostic equipment already installed in hospitals and urgent care centers.

2025: Study of more than 3,000 cases reported physician-aided patient management.
2025: A study published one year before the clearance study showed the test's sensitivity and specificity for bacterial infections.
One week before FDA clearance: Federal data showed a rise in antimicrobial-resistant infections and deaths.
2026-11-03
FDA clearance was announced for Access MeMed BV.

The Tech Race

The clearance adds a bacterial-versus-viral classification to existing immunoassay platforms rather than requiring new instruments. The stub does not name a competing test or research program for direct comparison.

The test returns a result in 15 minutes and is cleared for patients as young as 90 days, so it can be used at visits where clinicians currently must decide on antibiotics without a clear signal. Availability timing and pricing are not stated in the source.

The takeaway

The clearance shows whether rapid host-response testing can move routine antibiotic prescribing at scale, and it is worth tracking the test's real-world adoption at U.S. hospitals and urgent care centers. Watch for the first published clinical outcomes from facilities that run it.