FDA Clears 15-Minute Blood Test to Help Distinguish Bacterial From Viral Infections

The FDA has cleared a rapid blood test that helps clinicians determine whether an acute infection is more likely bacterial or viral, with results available in as little as 15 minutes, manufacturer Beckman Coulter Diagnostics announced November 3, 2026.¹

The Access MeMed BV assay, developed in collaboration with MeMed, is cleared for adults and for children as young as 90 days. It runs on Beckman Coulter's DxI 9000 and Access 2 immunoassay analyzers, which are already in use in hospital laboratories across the US, meaning facilities can adopt the test without purchasing new instruments or changing existing testing workflows. The 15-minute turnaround applies to the DxI 9000 analyzer.¹

How the test works

Rather than looking for a specific pathogen, the assay reads the body's immune response to infection. It measures 3 host proteins in serum or plasma—tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon gamma–induced protein 10 (IP-10), and C-reactive protein (CRP)—and combines them into a single score reflecting the likelihood of a bacterial infection.¹

The test is intended for patients with suspected acute infection and symptoms lasting fewer than 7 days who are evaluated in an emergency department (ED) or urgent care setting, or whose samples are collected at hospital admission. According to the company, results should be interpreted alongside clinical assessment and other laboratory findings.¹

MeMed BV first received FDA clearance in 2021 on MeMed's own point-of-need platform, MeMed Key.⁵ The new clearance extends the test to Beckman Coulter's high-throughput laboratory analyzers. The Access version received a CE mark in Europe in April 2026.¹

Why it matters for antibiotic stewardship

Bacterial and viral infections often look alike at presentation, and clinicians frequently have to decide on treatment before cultures or other definitive tests come back. That uncertainty contributes to antibiotic overuse: a CDC-led analysis estimated that about 30% of outpatient oral antibiotic prescriptions in the US are unnecessary, and roughly half of those written for acute respiratory conditions may not be needed.⁴

"In emergency medicine, clinicians frequently make treatment decisions before having complete diagnostic clarity," said Michael B. Holbrook, MD, MBA, FACEP, director of emergency informatics at Miami Valley Emergency Specialists, in the press release. Holbrook added that objective host-response data can help clinicians judge whether an infection is likely bacterial and explain to patients why antibiotics are or are not part of their care plan.¹

Melissa Naiman, senior director of medical and scientific affairs for acute care at Beckman Coulter Diagnostics, said the speed of the result is intended to give clinicians more confidence when weighing whether antibiotics are warranted, including for young children, who often present with nonspecific symptoms and may be unable to describe them.¹

Supporting evidence

In the prospective, blinded Apollo study, which enrolled patients at 9 EDs and 3 urgent care centers in the US and Israel, MeMed BV was evaluated in 476 adults and children against an expert-panel reference standard. The test demonstrated a sensitivity of 90.0% (95% CI, 80.3%-99.7%), a specificity of 92.8% (95% CI, 90.0%-95.5%), and a negative predictive value of 98.8% (95% CI, 96.8%-99.6%) for bacterial infection; 7.2% of results were equivocal. That study used the rapid MeMed Key platform.²

A 2025 pragmatic cohort study at 10 urgent care centers in Israel examined how the test performed in routine adult care. Among 3,262 cases, the test flagged 19.3% as potentially receiving unwarranted antibiotics, and physicians avoided prescribing in 63.1% of those cases. In a separate analysis of 2,901 cases, physicians reported that the test aided patient management in 86.0% and helped them avoid an ED referral in 20.5%.³

The company also cited health-economic modeling in community-acquired pneumonia estimating about 1,129 fewer antibiotic days per 1,000 patients when the test was added to standard care.¹ In addition, real-world data from Tampa General Hospital, where the test was added to the ED sepsis alert order set, showed an estimated $1,790 reduction in cost per patient, largely from avoided admissions among patients unlikely to have bacterial sepsis. MeMed funded research assistants and supplied tests for that analysis, which was presented at the Society for Academic Emergency Medicine 2026 annual meeting and is in publication.¹

Eran Eden, PhD, MeMed's chief executive officer and co-founder, said the clearance broadens access to host-response diagnostics in the US and could help clinicians identify bacterial infections that may progress to sepsis earlier.¹

What it means for primary care

The test is cleared for ED, urgent care, and hospital admission settings, so it is unlikely to be available in the office. However, your patients may increasingly arrive for follow-up after an urgent care or ED visit in which a host-response result informed whether they received an antibiotic, making familiarity with the test and its strengths—particularly in helping rule out bacterial infection—useful when reviewing those decisions.

References

1. Beckman Coulter Diagnostics receives U.S. FDA clearance for rapid bacterial vs. viral assay providing results in as little as 15 minutes for adults and children. News release. Beckman Coulter Diagnostics. November 3, 2026. https://www.prnewswire.com/news-releases/beckman-coulter-diagnostics-receives-us-fda-clearance-for-rapid-bacterial-vs-viral-assay-providing-results-in-as-little-as-15-minutes-for-adults-and-children-302927223.html
2. Bachur RG, Kaplan SL, Arias CA, et al. A rapid host-protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study. J Am Coll Emerg Physicians Open. 2024;5(3):e13167. doi:10.1002/emp2.13167
3. Kalmovich B, Rahamim-Cohen D, Yehoshua I, et al. Implementation of a rapid host-protein diagnostic test for distinguishing bacterial and viral infections in adults presenting to urgent care centers: a pragmatic cohort study. BMC Med. 2025;23(1). doi:10.1186/s12916-025-03903-8
4. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA. 2016;315(17):1864-1873. doi:10.1001/jama.2016.4151
5. FDA clears technology to distinguish between bacterial and viral infections. Clinical Lab Products. September 2021. https://clpmag.com/diagnostic-technologies/point-of-care/poc-instruments/fda-clears-technology-to-distinguish-between-bacterial-and-viral-infections/